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Home> Laws and Regulations
Provisions for Medical Device Registration
(Decree No. 4 of China Food and Drug Administration)
The Provisions for Medical Device Registration, adopted at the executive meeting of China Food and Drug Administration on June 27, 2014, is hereby promulgated and shall be effective as of October 1, 2014.
Minister: Zhang Yong
Chapter I General Provisions
Article 1 The Provisions is formulated in accordance with the Regulations on Supervision and Administration of Medical Devices, with a view to standardizing the administration of medical device registration and filing and guaranteeing the safety and effectiveness of medical devices.
Article 2 All medical devices sold and used within the territory of the People's Republic of China shall apply for registration or filing according to the Provisions.
Article 3 Medical device registration refers to the prescribed procedures conducted by the food and drug regulatory department upon an application submitted by the registration applicant to decide whether the medical device to be marketed can be sold based on a comprehensive evaluation of the research and results of its safety and effectiveness.
Medical device filing is a process that the filing entity submits the filing documents to the food and drug regulatory department and the food and drug regulatory department files the filing documents submitted by the filing entity.
Article 4 The medical device registration and filing shall be conducted under the principles of publicity, equity and justice.
Article 5 Class I medical device is subject to filing administration and class II and class III medical devices are subject to registration administration.
To apply for filing of class I domestic medical devices, the filing entity shall submit the filing documents to the food and drug regulatory department of the city consisting of districts .
Class II domestic medical devices shall be reviewed by the food and drug regulatory department of the provinces, autonomous regions and municipalities directly under the central government, and the medical device registration certificate shall be issued after approval.
Class III domestic medical devices shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.
To apply for filing of import class I medical devices, the filing entity shall submit the filing documents to China Food and Drug Administration.
Import class II and class III medical devices shall be reviewed by China Food and Drug Administration, and the medical device registration certificate shall be issued after approval.
The medical devices from Hong Kong, Macao and Taiwan shall be registered and filed by reference to the import medical devices.
Article 6 Where a registration applicant or filing entity of a medical device brings the products to the market in his own name, he shall take responsibilities for the product.
Article 7 The food and drug regulatory department shall publicize relevant information on medical device registration and filing promptly in accordance with laws. The applicant can look up the approval progress and relevant results as well as the public can look up the result of approval.
Article 8 The State encourages the research and innovation of medical devices, implements special review for innovative medical devices, accelerates the popularization and application for new technologies of medical devices and promotes the development of medical device industry.
Chapter II Essential Requirements
Article 9 The registration applicant and filling entity of medical devices shall establish a quality management system related to product research, development and manufacture and shall keep its effective operation.
Where applying for registration of a domestic medical device subject to the special review procedures for innovative medical devices and its sample production is entrusted to another enterprise, the applicant shall entrust a medical device manufacturer having corresponding production range. Where the domestic medical device applied for registration is not subject to the special review procedures for innovative medical devices, the sample production shall not be entrusted to another enterprise.
Article 10 The persons undertaking registration or filing for medical devices shall have corresponding specialized knowledge and be familiar with the laws, rules, regulations and technical requirements of the administration on registration or filing of medical devices.
Article 11 When applying for registration or filing, the applicant or filing entity shall complete the research and development of medical devices in accordance with the essential requirements for safety and effectiveness of medical devices and make sure the research and development process is true and standardized and all the data is authentic, complete and traceable.
Article 12 The documents for registration application or filing shall be in Chinese. Where they are translated from another language, the original documents shall also be provided at the same time. When referring to unpublished literature, the applicant shall provide documents proving the owner's permission to use the information.
The applicant and filing entity shall take full responsibility for the authenticity of the documents submitted.
Article 13 An import medical device being applied for registration shall be one which has already got permission for distribution in the country (region) where the applicant or filing entity is registered or the manufacture is carried out.
If the product is not managed as medical device in the country (region) where the applicant or filing entity is registered or the manufacture is carried out, the applicant or filing entity shall provide relevant proof documents, including the permission for distribution of sold product in the country (region) where the applicant or filing entity is registered or the manufacture is carried out.
Article 14 An overseas applicant or filing entity shall conduct related work with the support of its representative office established in China or an enterprise legal person in China designated by it as its agent.
The agent shall undertake the following liabilities in addition to conducting medical device registration or filing:
(I) Contacting with corresponding food and drug regulatory department and overseas applicant or filing entity.
(II) Delivering related laws and regulations and technical requirements to the applicant of filing entity in a truthful and faithful manner.
(III) Collecting post-market adverse event information of medical devices and sending feedback to overseas registrants or filing entity, meanwhile, reporting to relevant food and drug regulatory department.
(IV) Coordinating the medical device post-market product recall and reporting to relevant food and drug regulatory department.
(V) Other joint liabilities related to product quality and after-sales service.
Chapter III Product Technical Requirements and Registration Testing
Article 15 The applicant or filing entity shall prepare the product technical requirements for medical device to be registered or filed. The product technical requirements for class I medical devices shall be submitted to the food and drug regulatory department at the time of filing. The product technical requirements for class II and class III medical devices shall be approved by the food and drug regulatory department at the time of registration approval.
Product technical requirements mainly include the performance indicators and testing method of the finished medical device. Performance indicators refer to functional and safety indicators and other quality control indicators of finished medical devices that can be measured objectively.
The medical devices marketed in China shall comply with the product technical requirements which are approved by registration or filed.
Article 16 When applying for class II and class III medical device registration, registration testing shall be conducted. The medical device testing institutions shall carry out relevant registration testing on the products in accordance with the product technical requirements.
The production of samples for registration testing shall comply with relevant requirements of quality management system for medical devices. Clinical trials or registration application can be carried out only after the products passed the registration testing.
For the filing of class I medical device, the filing entity may submit the product self-testing report.
Article 17 For the application of registration testing, the applicant shall submit relevant technical documents and samples for registration testing, and product technical requirements as required according to the registration testing to the testing institutions.
Article 18 Medical device testing institutions shall have the relevant qualification of medical device testing, and perform testing within their specified testing scope. It shall carry out pre-evaluation of the product technical requirements. The pre-evaluation opinions together with the medical device registration testing report shall be submitted to the applicant.
For the medical devices having not included in the testing scope of any medical device testing institutions, the corresponding registration department shall designate a testing institution which has the capability to conduct the testing.
Article 19 The products being tested in one registration unit shall represent the safety and effectiveness for other products in the same registration unit.
Chapter IV Clinical Evaluation
Article 20 Clinical evaluation of medical devices refers to the process that the applicant or filing entity validates whether the products under registration can meet their intended use and indications based on the information of clinical literature, clinical experience data and clinical trials.
Article 21 Clinical evaluation materials refer to the documents developed through clinical evaluation by the applicant or filing entity.
Where clinical trial is required, the clinical evaluation materials to be submitted shall include clinical trial protocol and clinical trial report.
Article 22 For filing of a class I medical device, clinical trial is not required. For application for registration of a class II or class III medical device, clinical trial shall be conducted, however, in one of the following circumstances, clinical trial may be exempted:
(1) Where the functional mechanism of the device is definite, the design is finalized, the production process is well-established, and the marketed medical device of the same variety has been in clinical use for years and no serious adverse events are recorded, and its conventional purposes of use are not changed.
(2) Where safety and effectiveness of the device can be proved through non-clinical evaluation.
(3) Where safety and effectiveness of the medical device can be demonstrated through the analysis and assessment made on the basis of the data obtained from clinical trial or application of a medical device of the same variety.
The catalogue of medical devices that are exempted from clinical trial shall be compiled, adjusted and published by China Food and Drug Administration. Where, for products not listed in the catalogue of medical devices exempted from clinical trial, if the safety and effectiveness of the medical device can be demonstrated through the analysis and evaluation on the data obtained from clinical trials or clinical application of substantially equivalent medical devices, the applicant may give explanations and submit relevant supporting documents when applying for registration.
Article 23 The clinical trial of medical devices shall be conducted within a qualified clinical trial institution according to the requirements of the Good Clinical Practice (GCP) for medical devices. The production of samples used for clinical trial shall meet relevant requirements of quality management system for medical devices.
Article 24 Where the clinical trial of a class III medical device poses high risks to human body, it shall be subject to approval by China Food and Drug Administration. The catalogue of class III medical devices subject to clinical trial approval shall be compiled, adjusted and published by China Food and Drug Administration.
Article 25 The examination and approval of a clinical trial is a process that China Food and Drug Administration conducts a comprehensive analysis to the degree of risk the device may entail, clinical trial protocol, comparative analysis report on clinical benefit and risk of the device to be put on clinical trial, to determine whether to approve the clinical trial.
Article 26 Where a clinical trial approval is required, the applicant shall submit the application documents to China Food and Drug Administration in accordance with related requirements.
Article 27 After accepting the application for approval of clinical trials, China Food and Drug Administration shall forward the application documents to technical evaluation institution within 3 workdays from the date of application acceptance.
The technical evaluation institution shall complete the technical evaluation within 40 workdays and China Food and Drug Administration shall make decisions within 20 workdays after technical evaluation. If the application of clinical trial is approved, the Approval Letter for Clinical Trial of Medical Device shall be issued. If the application is disapproved, the reasons shall be stated in written form.
Article 28 Where supplementary and correction materials are required during technical evaluation, the technical evaluation institution shall inform the applicant one-off of all the supplements to be completed. The applicant shall submit all necessary supplementary and correction materials one-off within one year according to the supplementation notice. The technical evaluation institution shall complete the technical evaluation within 40 workdays from the date of acceptance of the supplements. The time spent by applicant for supplementing such materials shall not be calculated in the overall evaluation time.
Where the applicant fails to submit the supplementary materials within the specified timeline, the technical evaluation institution shall terminate the technical evaluation and come up with a disapproval suggestion, and China Food and Drug Administration shall make a disapproval decision after confirmation.Article 29 In any of the following circumstances, China Food and Drug Administration shall revoke the issued approval document for medical device clinical trials:
(I) The application materials are spurious.
(II) The latest research confirms that an already approved clinical trial has existing problems in ethicality and scientificalness.
(III) Other circumstances under which an approval document for a medical device clinical trial shall be revoked.
Article 30 Clinical trials of medical devices shall be conducted within 3 years after approval. Where it is not conducted in due time, the original approval document shall be invalid automatically. Where the clinical trial still needs to be conducted, a new application shall be submitted.
Chapter V Product Registration
Article 31 To apply for medical device registration, the applicant shall submit application documents to the food and drug regulatory department in accordance with relevant requirements.
Article 32 The food and drug regulatory department shall conduct preliminary review after accepting an application, and handle respectively according to the following circumstances:
(I) Where the application is within functions and duties of department, and the application materials are complete and meet the preliminary review requirements.
(II) Where the application materials have errors that may be corrected on the spot, the applicant shall be allowed to correct them on the spot.
(III) Where the application materials are incomplete or do not meet the preliminary review requirements, the applicants shall be informed one-off of all the supplements or corrections required within 5 workdays. Where the application is not informed, the application shall be deemed as accepted from the date the application materials are received.
(IV) Where an application is not within the functions and duties of the department, the applicant shall be notified immediately of unacceptance.The food and drug regulatory department shall grant a dated acceptance or rejection notice affixed with its special seal to indicate its acceptance or rejection of the medical device registration application.
Article 33 The food and drug regulatory department accepting the registration application shall forward the application materials to technical evaluation institution within 3 workdays from the date of acceptance.
The technical evaluation institution shall complete the technical evaluation within 60 workdays for class II medical device registration, and within 90 workdays for class III medical device registration.
Where experts shall be invited for an evaluation, or in case of a drug-device combination product, a joint evaluation with the drug evaluation institution is required, the time spent shall not be calculated in the overall evaluation time. The technical evaluation institution shall notify the applicant of the time needed in writing.
Article 34 The food and drug regulatory department may refer to the original research data when organizing a technical evaluation for product registration, and organize an inspection of the applicant's quality management system concerning product research, development and production.
For domestic class II and class III medical device registration, the quality management system shall be inspected by the food and drug regulatory department of the provinces, autonomous regions and municipalities directly under the central government. In case the quality management system inspection is for a domestic class III medical device, the technical evaluation institution of China Food and Drug Administration shall notify the food and drug regulatory department of the corresponding province, autonomous region and municipality directly under the central government to carry out the inspection, and participate in the inspection when necessary. The food and drug regulatory department of the province, autonomous region or municipality directly under the central government shall complete the inspection within 30 workdays according to relevant requirements.
When conducting technical evaluation for an import class II or class III medical device, if the technical evaluation institution of China Food and Drug Administration deems it necessary to conduct a quality management system inspection, it shall notify the technical institution for quality management system inspection of China Food and Drug Administration to carry out the inspection according to relevant requirements. The technical evaluation institution shall participate in the inspection when necessary.
The time for quality management system inspection shall not be calculated in the overall evaluation time.
Where the applicant has an objection to the content of the notice for supplements or corrections, it may submit its written opinions to the corresponding technical evaluation institution, to explain its reasons and provide corresponding technical supporting materials.
Where the applicant fails to submit the supplementary materials within the specified timeline, the technical evaluation institution shall terminate the technical evaluation and come up with a disapproval suggestion, and China Food and Drug Administration shall make a disapproval decision after confirmation.
Article 36 The food and drug regulatory department accepting the registration application shall make a decision within 20 workdays after technical evaluation. For that meeting safety and effectiveness requirements, the registration shall be approved, and a medical device registration certificate shall be issued within 10 workdays from the date of approval, and the approved product technical requirements shall be issued as an attachment to the applicant. For that disapproved, reasons shall be given in writing, and the applicant shall be informed of its right to apply for a re-evaluation and for an administrative reconsideration or administrative litigation in accordance with laws and regulations.
The period of validity of the medical device registration certificate is five years.
Article 37 Medical device registration items include permission items and registry items. The permission items include product name, model, specifications, structure and composition, scope of application, product technical requirements, etc., and for an import medical device, production site. The registry items include the name and residence of the registrant, the name and residence of the agent and address of production site of domestic medical devices, etc..
Article 38 For a medical device which is used to treat a rare disease or is urgently needed in dealing with emergent public health incidents, the food and drug regulatory department may require its applicant to further complete relevant work after the product is put on market, and specify the requirements on the medical device registration certificate.
Article 39 For accepted registration applications, where one of the following circumstances exists, the food and drug regulatory department shall decide to reject the application and notify the applicant:
(I) The research conducted by the applicant and its result cannot prove the safety and effectiveness of the medical device to be sold on the market.
(II) The registration application materials are spurious.
(III) The registration application materials have confused or inconsistent contents.
(IV) The registration application materials are obviously inconsistent with application items.
(V) Other circumstances under which the registration application shall not be approved.
Article 40 For an accepted registration application, the applicant may, prior to the administrative permission decision is made, withdraw the registration application and relevant materials, and give reasons to the food and drug regulatory department which accepted the application.
Article 41 For an accepted registration application, where there are evidences indicating that the registration application materials may be spurious, the food and drug regulatory department shall suspend the evaluation and approval process. After investigation, the food and drug regulatory department shall determine to continue the process or to reject the registration application in accordance with the investigation conclusion.
Article 42 Where an applicant has an objection to the disapproval decision of the food and drug regulatory department, it may submit a re-evaluation application within 20 workdays after receiving the disapproval notice to the food and drug regulatory department that made the decision. Contents of the re-evaluation application shall be limited to original application items and original application materials.
Article 43 The food and drug regulatory department shall make a re-evaluation decision within 30 workdays after accepting the re-evaluation application and inform the applicant. Where the original decision shall be maintained, the food and drug regulatory department shall not accept further application for re-evaluation by the applicant.
Article 44 Where the applicant has an objection to the disapproval decision of the food and drug regulatory department, and has applied for an administrative reconsideration or administrative litigation, the food and drug regulatory department shall not accept its re-evaluation application.
Article 45 Where a medical device registration certificate is lost, the registrant shall publish a loss declaration immediately at the media specified by the original certificate-issuing authority, and apply after 1 month of declaration to the original certificate-issuing authority for re-issuing the certificate. The original certificate-issuing authority shall re-grant the medical device registration certificate within 20 workdays.
Article 46 Where major interest relationship between the applicant and others is directly involved in the application for medical device registration, the food and drug regulatory department shall inform the applicant and the interested party of their right to apply for a hearing in accordance with laws, regulations and other provisions of China Food and Drug Administration. During the process of reviewing the application for medical device registration, if the food and drug regulatory department believes there are major licensing issues concerning public interests, it shall make a public announcement and hold a hearing.
Article 47 For a newly developed medical device not yet listed in the classification catalogue, the applicant may directly apply for a class III medical device registration, or may determine the classification of the product according to the classification rules and apply to China Food and Drug Administration for a class confirmation, and apply for product registration or for filing thereafter.
Where a class III medical device registration is directly applied for, China Food and Drug Administration shall determine the class according to its risk degree. Where a domestic medical device is determined as class II, China Food and Drug Administration shall forward the application materials to the food and drug regulatory department of the province, autonomous region or municipality directly under the central government where the applicant is located, for evaluation and approval. Where a medical device is determined as class I, China Food and Drug Administration shall forward the application materials to the food and drug regulatory department of the city consists of its districts where the applicant is located, for filing.
Article 48 Where a patent dispute arises during the registration review or after approval, it shall be dealt with according to relevant laws and regulations.
Chapter VI Registration Alteration
Article 49 For a registered class II or class III medical device, if the content of the medical device registration certificate and its attachment(s) has an alteration, the registrant shall apply to the original registration department for registration alteration and submit application materials according to relevant requirements.
Where the alteration is for product name, model, specifications, structure and components, scope of application, product technical requirement, etc., and for an import medical device, production address, the registrant shall apply to the original registration department for change of permission items.
Where the alteration is for name, residence of the applicant and the agent, the registrant shall apply to the original registration department for change of registry items. Where the alteration is for production address of a domestic medical device, the registrant shall apply for change of registry items after the corresponding production license is changed.
Article 50 Where the application documents for change of registry items conform to the requirements, the food and drug regulatory department shall issue the medical device registration alteration document within 10 workdays. Where the application documents are not complete or do not meet the requirements for preliminary review, the food and drug regulatory department shall inform the applicant all the documents needed to be supplemented and corrected.
Article 51 For change of permission items, the technical evaluation institution shall focus on evaluating the changed parts and give comments on product safety and effectiveness after the change.
The food and drug regulatory department accepting the application for change of permission items shall organize technical evaluation within the period specified in Chapter V of the Provisions.
Article 52 The medical device registration alteration document shall be used in conjunction with the original medical device registration certificate and its period of validity shall be the same with that of the original registration certificate. After obtaining the registration alteration document, the registrant shall alter the product technical requirements, instructions and labels by himself.
Article 53 Where provisions concerning acceptance and approval procedures of the application for change of permission items are not available in this chapter, Chapter V of the Provisions shall prevail.
Chapter VII Registration Renewal
Article 54 Where it is required to extend the period of validity of the medical device registration certificate, the registrant shall submit application for registration renewal to the food and drug regulatory department six months before the expiration of period of validity and submit application documents according to corresponding requirements.
Except for the situations specified in Article 55, the food and drug regulatory department receiving the application for registration renewal shall make a decision for the renewal before the expiration of period of validity of the medical device registration certificate. If the decision is not made within the specified time, the renewal is considered approved.
Article 55 The registration renewal shall not be approved in any of the following circumstances:
(I) The registrant fails to submit the application for registration renewal within the specified period.
(II) The mandatory standard(s) of the medical device has been revised, and the medical device fails to meet the requirements of the new standard(s).
(III) For a medical device which is used to treat a rare disease or is urgently needed in dealing with emergent public health incidents, the registrant fails to complete items stated in medical device registration certificate within specified time as required by registration department upon approving such registration.
Article 56 Where provisions concerning acceptance and approval procedures of application for registration renewal of medical device are not available in this chapter, Chapter V of the Provisions shall prevail.
Chapter VIII Product Filing
Article 57 Filing for a class I medical device shall be conducted prior to production.
Article 58 For a medical device filing, the filing entity shall submit the filing documents in accordance with Article 9 of the Regulations on Supervision and Administration of Medical Devices.
Where the filing documents meet the requirements, the food and drug regulatory department shall complete the filing on the spot. Where the filing documents are not complete or do not meet the filing requirements, the filing entity shall be informed of all the supplements and corrections to be made one- off, for filing after supplements and corrections.
For a filed medical device, the food and drug regulatory department shall make filing certificates according to the format in relevant requirements and publish the information from the filing information form for medical device on their website.
Article 59 For a filed medical device, where the contents set forth in the filing information form for medical device changed, the filing entity shall submit a description of the change and related supporting documents to the original filing department and apply for change of filing. Where the filing documents meet the format requirements, the food and drug regulatory department shall put the changes in the information of changes, and file a record.
Article 60 Where the management classification of a filed medical device is adjusted, the filing entity shall apply to the food and drug regulatory department for cancellation of the original filing. Where the management classification is adjusted to a class II or class III medical device, the filing entity shall apply for registration in accordance with the Provisions.
Chapter IX Supervision and Administration
Article 61 China Food and Drug Administration shall be responsible for the supervision and administration of medical device registration and filing nationwide, and supervise and guide the medical device registration and filing by local food and drug regulatory departments.
Article 62 The food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and administration of medical device registration and filing within their administrative areas, and organize supervision and inspection and report relevant situations to China Food and Drug Administration.
Article 63 The food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall, in accordance with the principle of territorial administration, perform routine supervision and administration over the work concerning registration and filing done by agents for import medical devices.
Article 64 The food and drug regulatory departments of the cities consisting of districts shall perform regular examination over the filing of medical devices and timely report relevant information to the food and drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government.
Article 65 Where, for a registered medical device, there exists a revocation situation in accordance with laws and regulations, or a registrant applies for revocation before the expiration of a registration certificate, the food and drug regulatory department shall revoke the registration certificate according to law and disclose to the society.
Article 66 Where, for a registered medical device, the management classification is adjusted from a higher class to a lower one, the registration certificate within its period of validity shall remain valid. Where a renewal is needed, the registrant shall apply for registration renewal or filing on changed classification to corresponding food and drug regulatory department six months prior to the expiration of period of validity of the registration certificate.
Where, the medical device classification is adjusted from a lower class to a higher one, the registrant shall apply for registration on changed classification to the corresponding food and drug regulatory department in accordance with the provisions in Chapter V hereof. China Food and Drug Administration shall specify a time limit for completing the adjustment in the notice on adjusting management classification.
Article 67 Where a food and drug regulatory department of a province, autonomous region or municipality directly under the central government conducts a medical device registration by violating the Provisions, China Food and Drug Administration shall order it to correct within a deadline. Where it fails to correct before the deadline, China Food and Drug Administration may directly announce a revocation of the medical device registration certificate.
Article 68 The food and drug regulatory departments, relevant technical institutions and their staff shall be liable for the confidentiality of all the trial or testing data and know-how submitted by the applicant or filing entity.
Chapter X Legal Responsibilities
Article 69 Where a medical device registration certificate is obtained by providing spurious documents or by other deception means, punishments shall be imposed according to Paragraph 1, Article 64 of the Regulations on Supervision and Administration of Medical Devices.
Where a filing is done by providing spurious documents, punishments shall be imposed according to Paragraph 2, Article 65 of the Regulations on Supervision and Administration of Medical Devices.
Article 70 Where a medical device registration certificate is falsified, altered, bought or sold, leased or lent, punishments shall be made according to Paragraph 2, Article 64 of the Regulations on Supervision and Administration of Medical Devices.
Article 71 Where, in violation of the Provisions, a change of filing for a class I medical device is not performed, or a registration alteration of registry items for a class II or class III medical device is not performed according to law, punishments shall be imposed according to the situation concerning fail in filing in the Regulations on Supervision and Administration of Medical Devices.
Article 72 Where, in violation of the Provisions, a registration alteration of permission items for a medical device is not performed according to law, punishments shall be imposed according to the situation concerning not obtaining a medical device registration certificate in the Regulations on Supervision and Administration of Medical Devices.
Article 73 Where a clinical trial performed by an applicant is not in accordance with the Regulations on Supervision and Administration of Medical Devices and the Provisions, the food and drug regulatory department at or above the county level shall order for rectifications and may impose a penalty of less than 30,000 yuan(RMB). In case of severe conditions, the clinical trial shall be stopped immediately. Where a clinical trial approval document is already obtained, it shall be cancelled.
Chapter XI Supplementary Provisions
Article 74 Medical device registration or filing units shall in principle be classified according to the technical mechanism, structural composition, performance indicators and scope of application of the product.
Article 75 Where, in the column of "Structure and Components" of a medical device registration certificate, the combining components listed is used on the original registered product for the purpose of replacing consumables, after-sales service, and maintenance, etc., they may be sold individually.
Article 76 The format of the medical device registration certificate shall be prepared by China Food and Drug Administration.
The registration number shall be arranged in the following form:
×1 XZ ×2××××3×4××5××××6. Among which,
×1 shall be the abbreviation of the place where the registration department is located.
The letter "G" shall refer to domestic class III medical devices and import class II and III medical devices.
The abbreviation of the provinces, autonomous regions and municipalities directly under the central government where the registration department is located shall be adopted for domestic class II medical devices.
×2 shall indicate the form of registration.
"Z" is applicable to domestic medical devices.
"J" is applicable to import medical devices.
"X" is applicable to medical devices from Hong Kong, Macao and Taiwan.
××××3 shall indicate the year of initial registration.
×4 shall indicate the classification.
××5 shall indicate the product classification code.
××××6 shall indicate the serial number of initial registration.
For the registration renewal, ××××3 and ××××6 shall remain the same. In case of the management classification changed, a new registration number shall be issued.
Article 77 The filing certificate for class I medical device shall be arranged in the following form:
×1 XB××××2××××3. Among which,
×1 shall be the abbreviation of the place where the filing department is located.
The letter "G" shall refer to import class I medical devices.
The abbreviation of the provinces, autonomous regions and municipalities directly under the central government combines the abbreviation of city divided into districts where filing department is located (if there is no corresponding city divided into districts, only use the abbreviation of province, autonomous region or municipality directly under the central government) shall be adopted for domestic class I medical device.
××××2 shall indicate the year of filing.
××××3 shall indicate the serial number of filing.
Article 78 The Provisions for In-Vitro Diagnostic Reagent Registration shall be applicable to the registration and filing of in-vitro diagnostic reagents administered as medical devices.
Article 79 The emergency approval procedure for medical devices and the special approval procedure for innovative medical devices shall be separately formulated by China Food and Drug Administration.
Article 80 China Food and Drug Administration may, according to necessity, authorize the food and drug regulatory departments or technical organizations of provinces, autonomous regions and municipalities directly under the central government and relevant social organizations to conduct the specific work related to the registration of medical devices.
Article 81 The charging items and the charging standards for medical device registration shall be determined in accordance with the relevant regulations formulated by the competent finance department and the competent pricing department of the State Council.
Article 82 The Provisions shall be effective as of October 1, 2014. The Provisions for Medical Device Registration promulgated on August 9, 2004 (Decree No. 16 of the former State Food and Drug Administration) is annulled simultaneously.
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--Kabir S, Emerging Markets
China SignPost™ 洞察中国 founders Dr. Andrew Erickson and Mr. Gabe Collins have more than a decade of combined government, academic, and private sector experience in Mandarin Chinese language-based research and analysis of Greater China. In 2010, they established China SignPost to offer greater understanding of key Chinese developments of disproportionate impact, with particular focus on natural resource, technology, industry, and trade issues.
China SignPost offers the full text of more than 75 of Dr. Erickson and Mr. Collins' coauthored studies, with exclusive access to new reports each month. With a unique combination of breadth and depth, they go where others can't go to deliver insights spanning a wide range of data sources, disciplines, and experiences to identify areas of risk, value, and opportunities in the world's fastest growing multi-trillion dollar economy.
Dr. Andrew S. Erickson
Dr. Andrew S. Erickson is an Associate in Research at Harvard University's John King Fairbank Center for Chinese Studies. He serves as an expert contributor to the Wall Street Journal's China Real Time Report and as a term member of the Council on Foreign Relations. Dr. Erickson is also a Professor of Strategy at the U.S. Naval War College. He has lectured extensively at government, academic, and private sector institutions throughout the United States and Asia. Dr. Erickson received his Ph.D. and M.A. in international relations and comparative politics from Princeton University. He previously worked at Science Applications International Corporation (SAIC), the U.S. Embassy in Beijing, the U.S. Consulate in Hong Kong, the U.S. Senate, and the White House. Proficient in Mandarin Chinese and Japanese, he has lived in China, Japan, and Korea. He blogs at www.andrewerickson.com.
Mr. Gabe B. Collins
Mr. Gabe B. Collins is a private researcher and author of more than 100 detailed research reports. He regularly consults with clients to assess potential commodity investment opportunities. Mr. Collins' in-depth, custom research concerning emerging markets is supported through his proprietary network of local contacts in emerging markets. His work focuses on identifying unique global opportunities for asset allocation. Mr. Collins has worked in government and as a private sector global commodity analyst and investment advisor, and subsequently as a private commodity researcher. He regularly conducts commodity and market research in Chinese, Russian, and Spanish. He is the co-founder of www.chinasignpost.com and www.chinaoiltrader.com. Gabe received his B.A. from Princeton University and his J.D. from the University of Michigan Law School.
Consumer Economy
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Slowing Overall Growth, Gasoline Replacing Diesel as Demand Driver, Refined Product Exports Rising Substantially Executive Summary: –Three key factors characterize the "new normal" of China's oil…

redpajama_set_name: RedPajamaCommonCrawl


text:
Separation Consciousness vs. Universal Consciousness | Excerpts from Children of the Law of One (CLO)
(Stillness in the Storm Editor) The following are several excerpts from the book Children of the Law of One and the Lost Teachings of Atlantis (CLO).
This work was written by Jon Penial and published in the late 1990s to help prepare humanity for the coming changes in consciousness.
From a content perspective, it is by far one of the densest works of ancient truth and wisdom ever written. Not unlike the Law of One, Ra Material, the CLO is a breathtakingly inspiring piece of writing that incorporates profound spiritual wisdom within a framework of extremely simple and easy to understand language. Whether you are a spiritual adept or just curious about Atlantis, arguably all readers have insights to gain from this work.
Personally, I have read my share of spiritual books about psychology, universal law, and the human condition, but never have I read a work so easy to understand yet so precise in what it has to say.
For those struggling to understand the Law of One channelings, this work is an excellent companion piece. Although the two works are completely independent of each other the ideational content is equivalent.
Related Soul Origin, Life Purpose and Volunteer Incarnations | The Final Wave of Souls is Here & It's Going to Change Everything
Arguably, if one were to read and comprehend the totality of what is contained in the CLO, they would have laid claim to a great portion of the spiritual knowledge available to mankind at this time.
Buy Book: The Children of The Law of One & The Lost Teachings of Atlantis
The following excerpts are in a dialog format and can be read as such.
Source - Esoteric Empyre
by Jon Penial
Separation Consciousness
Separate self consciousness, because of its limitations and narrow-mindedness, 'boxes' its perceptions of the world into 'pieces' that are extensions of its self. Everything in your immediate world becomes an extension of you, of your separate self. For instance, there is your neighborhood, your town, your county, your state, your country, your part of the world (and depending on your socio-economic status, possibly your gang's turf). Because the separate self relates to these as extensions of itself, most people support their country, for instance, just because it is their country. Sure, they come up with 'reasons' why their country is the best or most important. But the problem is, many people believe that their country is 'It', 'the best', the 'most important', the 'most right', regardless of any reason to think so or not. And by so doing, they care less about other countries, and the people of those other countries. And if everyone's country is the best, who's right? They can't all be right.
This phenomenon is even worse when it comes to a person's outlook about their religion. Many people think theirs is the only right religion, and thus the only one that will provide salvation for anyone else. And many of these people actually hate other religions, and their practitioners. When there is more than one religion claiming to be 'THE' only right one, it creates a question of who's right and who's wrong, and the dilemma of choosing the right one, or facing the consequences of having chosen the 'wrong' one (not getting into heaven, going to hell, etc.). But getting back to the idea of everyone thinking their country is the best, consider this: what country ever went into battle without 'God on their side'? In WWII, all sides believed God was on their side, including the Nazis. What country starts a war thinking that they're in the wrong? All of these perceptions and beliefs originate from separate selves and the territories they consider extensions of them-selves.
Most everyone favors not just their country, but ALL the extensions of their separate selves—they favor their race, favor their ethnic group, favor their school, favor their local team, favor their political party, etc., etc.. But a precious few people have begun to expand their self-consciousness to include 'bigger pictures'.
Take, for example, those who have become so environmentally conscious that they are 'environmentally active'. Those who have achieved that, understand the importance of the flow and balance of nature on Earth. They know that saving whales and forests, or seemingly insignificant things, such as tiny birds, fish, or ferns, can seriously alter life in ways that most people don't even suspect. Many of those who are truly environmentally conscious, have transcended some of their separate consciousness, and thus some of their self-centeredness, and self-ishness. Thus preserving the integrity of the environment is more important to them than many of the conveniences or inconveniences (recycling, power usage, etc., etc.) involved.
There is a story about a 'mountain man' from the United States named 'Grizzly Adams' that relates to this. When a beaver dammed the creek next to his cabin, threatening to flood his cabin, he moved and built a new cabin rather than disturb the beaver dam. Talk about inconvenience! And believe it or not, this was still limited consciousness—but what a wonderful expansion of consciousness. To have reverence for all life, and also be able to see the importance and potential effect of the lives of whales, and tiny fish, and a seemingly insignificant fern, is higher consciousness. But it still falls far short of Universal Consciousness, and the efforts of such people can be a total waste of time, or even harmful, without it.
"The human race barely cares about people let alone plants and animals. I remember once seeing a breaking news story about 600,000 people who died in an Earthquake. It was in the L.A. Times. You would expect such a disaster to be on the front page. And be a long article. But it was only one small paragraph, about 40 words, buried on page 9. And the only reason why was because the quake was in China. Even then, I was shocked. Can you imagine how this article would have been treated if 600,000 French people had died? English? American?" (Of course, this was during a time when the U.S. was an enemy of China. The story now, would be bigger news at least, if for no other reason than because there would be 600,000 less Chinese consumers of American products).
And those with separate self-consciousness will defend their views with twisted logic. Some people will say 'So what if I think my country is the most important? It's good to have national pride. It doesn't change anything about any other country, it just helps this one be better.' If you don't think that such an attitude has no effect on other countries, consider the atrocities that one country will often inflict on another. Or that a country will stand by and allow to happen to the citizens of one country, but not in another. Imagine invading soldiers regularly using bayonets to cut babies out of the wombs of 9-month pregnant women in the street, for purposes of genocide. That happens. But as long as it only happens in countries that other countries don't care about, no one cares. As things are, such things are nearly never reported in the news media of the world. What if it was going on in Chicago? England, France, Mexico? Do you think we would not even be hearing about it? If ALL the churches in Britain were being destroyed by invading armies, and the priests tortured, would it not get on the news? It would not only get on the news, but many countries would send troops over there to stop it in an instant.
How's that for national pride? What national pride?
It all depends on what our separate selves consider 'extensions' or relations of themselves, or have selfish stake in. Some people have begun to transcend 'pride of country'. Again, this is good, but it does not go far enough. So few have a truly global feeling of family, but there are some who do. But even environmental and humanitarian consciousness is still limited, and a person could accidentally cause terrible disasters acting from limited perception, even if their intention was only to help. All these expansions of consciousness are steps toward the ultimate expansive and caring consciousness, Universal Consciousness. But they are still all variations of separate self-consciousness—limited by so many constraints, and ultimately mistake ridden and destructive. Oh, how many tears have been shed in the wake of things gone wrong, and the cry is echoed 'But I was only trying to help'.
The fact is, all things in the Universe are essentially made of the same 'stuff', and are totally interdependent and connected. So we cannot be truly separate from the rest of the Universe, we can only be a 'part' of it all ('apart'). But we can think we are separate. We can believe we are separate. And then we act like we are separate. Having separate self-consciousness doesn't mean you are really separate, but it does mean having a total 'illusion' of separateness from everyone and everything else in the Universe. And when a person truly believes they are separate, they naturally focus on themselves. And when someone believes they are separate, and they focus their attention, and their energy, on their 'self', this naturally leads to 'self'ishness. This is very important, pay close attention. This is the BIG issue. The Big problem of all problems. The only REAL problem. As silly and simple as it sounds, it is serious - simple selfishness is the root of all problems and 'evils' that exist on Earth. This is one of the greatest, most important teachings to understand, so say it back to me—selfishness is the root of all problems and 'evils' that exist on Earth.
The Earth is just one speck of dust, within an incredibly greater scheme of things. Outside of the Earth, the entire Universe functions in a beautiful, orderly, harmonious flow. On Earth, humans with separate self consciousness, are the only things that are out of step with the flow of nature, and the Universe. And the results of this have been disharmony, disruption, and destruction. That's why the teachings promote the attainment of "Universal Consciousness", by any means that works for you.
[Additional excerpts added below]
We will cover the Children's teachings about how humans attained separate self-consciousness in the ancient history chapter, and the particulars of each individual's "selfish separate self" later in a "separate" chapter, but first, let's go over the meaning of Universal Consciousness.
"Please tell me more of the teachings on Universal Consciousness, enlightenment, and it's attainment."
"Universal Consciousness is attained when a person has a lasting experience in which they see through their illusion of separateness, and lose their separate self-consciousness. Their consciousness then 'merges' with the Universe - thus they experience being One with the Universe. This is often the result of going through a conscious psychological 'death experience', brought on by meditation and other aspects of a spiritual path [Author's note: these are explained in another chapter]. The illusion of separateness dissolves in the awareness of Oneness. And with the dissolution of the illusion of separateness, the separate self 'seems' to die, and a 'rebirth' occurs.
Separate self-consciousness is transcended and transformed. The dominant consciousness becomes that of the Inner Self, the part of us that is the Universal Spirit—thus, we have 'Universal Consciousness'. When experienced properly, a person is never the same, and never 'sees things' the same way again. From then on, all things are understood in the light of the 'biggest picture', in the light of being One with the Universal Spirit (God). Selfishness thus becomes a thing of the past. This is also called achieving 'enlightenment', and a few other names.
Related Restoring Wholeness by Integrating the Conscious and Subconscious Mind | Conscious Breathing Meditation (Beginner)
The difference between having separate self-consciousness, or having Universal Consciousness, is, as I said before, like night and day. Consider again, an environmentalist who has expanded his/her separate self-consciousness to include concern for ecology. This is good. And if being aware of the flow and balance of Earth's nature is good, imagine the significance of being really aware of the flow and balance, of all things—of the entire Universe? And if being concerned about all humans on Earth is good, what about being devoted to caring for all life within the entire Universe? A person who has attained Universal Consciousness, has transcended separate self-consciousness, and thus sees infinitely more, under- stands infinitely more.
Imagine being able to 'see' the outcome of many of your actions in advance—or whether or not you 'see' the outcome, being able to know if what you are doing is really going to ultimately help, or ultimately harm. Or using the classic car allegory again, imagine seeing one side of the car, and not assuming that the other side is the same? How would you like to be able to sense what all sides were like?"
"That would be incredible Father."
"Yes? That is just a small nothing. What if you really had an awareness of being One with everything—even God, even all other separate selves? How would you see things then? And how would you treat everyone and everything? If you absolutely KNOW that every person you are dealing with, is you, just in a different form, how will you treat yourself (others)? Is there any point in stealing from your- self? Hurting yourself? Is there any point in being tyrannical with yourself?"
"It would make no sense, there would be no point if you really believed that to be true."
"Precisely. A being with Universal Consciousness Loves everyone unselfishly, and is (within the needs of Universal flow) giving, kind, compassionate, caring, knowing, and harmless (that doesn't mean incapable of defending the innocent). Why? Is it because the person has read something that made them that way? Studied to be that way? Trained to be that way? No. Maybe such things were stepping stones on the path towards attainment of that consciousness, but once there, the fact is that being any other way simply makes no sense to someone with Universal Consciousness. It just is their reality—it is just natural.
Related Fractal Universe | Proof of Consciousness and a Creator, the Dreamer within the Dream – Understanding the Fibonacci Sequence and Golden Ratio
Excerpts from Children of the Law of One and the Lost Teachings of Atlantis.
For more see atlantis.to
[PS: Inadvertently, I have been discussing the same philosophic core teachings in the Gaia Portal interpretations well before reading this book in early 2016. I have since that time begun adding more of the vernacular and conceptual syntax from the CLO to enhance reception of the core principles of existence and our role here as spiritual children of the divine.]
The original headline of this article was changed from "Separate Consciousness (ego)," and additional excerpts of text were added.
http://www.esotericempyre.com/single-post/2016/07/22/Separate-Consciousness-ego
Labels: awakening , CLO , consciousness , disclosure , regain sovereignty , self education , self governance
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text:
Entertainment News: Sunday, August 15, 1999
'Prime Time' filled with tricks
By Mark Lindquist
Special to The Seattle Times
In his book "On Becoming a Novelist," John Gardner, the writer and teacher who was a mentor to Raymond Carver among many others, had this advice for writers:
"One of the most common mistakes among young writers is the idea that a story gets its power from withheld information – that is, from the writer's setting the reader up and then bushwhacking him."
Bushwhacking is an unfortunate technique of playwright Brent Askari in his first novel. He ends chapters with sentences like, "And when I did find out the truth, it blew my mind." This is especially unfortunate because his story does not need cheap tricks.
Justine Nichols, the narrator, a 22-year-old lead singer for an all-girl band, is a charming and engaging character. Abandoned by her parents and raised by an alcoholic aunt, she's an intriguing study in dysfunction. Askari's writing continually rings true in this territory.
Justine's bandmates are drawn equally well: "Tara didn't fit in with any of the high school crowds. Even the angst-ridden life-sucks-so-let's-dress-in-black-and-worship-death crowd didn't like her, because they thought she was a downer."
I would have liked to spend more time with the band, but the story moves, as it must, to Justine's confrontation with her mother, a TVstar Justine has never seen in the flesh. Their face-to-face comes in the hospital where the mother is staying after a suicide attempt. This scene, like most of the emotional high points, is handled with grace and wit.
Through the course of the story, Justine has two boyfriends who are her dysfunctional equals, but she is clearly not ready for love. By the end, having confronted her past and herself, she may be.


text:
Q: How to render a component using variable or props? The class receives the props.name which is the name from another Component, but it not renders properly.
class Component extends React.Component{
  constructor(props){
    super(props);
  }

  render(){
    var Element = this.props.name;
    return (
        <Element />
    )
  }
}

const Dropdown = () =>{
    return(

       <select>
          <option value="initial" selected>Select...</option>
          <option value="grapefruit">Grapefruit</option>
          <option value="lime">Lime</option>
          <option value="coconut">Coconut</option>
        </select>

  )
}

class App extends React.Component {
  state = {
    components: []
  };

  render() {
    return (

        <Component components={this.state.components} name="Dropdown" />

    );
  }
}

ReactDOM.render(<App />, mountNode);

The component renders fine when I write manually the name of the Component. For example:
render(){
  var Element = this.props.name;
  return (
       <Dropdown />
  )
}

A: How do you expect to generate Component out of string???
Do this:
class App extends React.Component {
  state = {
    components: []
  };

  render() {
    return (

        <Component components={this.state.components} name={Dropdown} />

    );
  }
}

A: You need to pass the props as tag argument. ex: . see the below example.
class parent extends React.Component{
constructor(){
super();
this.state={
   name:'ABC',
 }
}
render(){
   return(
  <Child argument={this.state.name} />
  )
 }
}

//stateless component don't have state
 function Child(props){
 return
{this.props.arguments}

}

A: Instead of passing the string from parent component, pass it like this:
<Component components={this.state.components} name={Dropdown} />

I think reason is:
<Element>  will get converted into React.createElement(Element, {}) and which expect the first argument as a react component name, or a string (HTML tag), since you want to render a react component so don't pass the name as string.

A: In the render() method you have to return one React element. That React element has to be a representation of DOM element. In your case you're trying to render a string, and that's the reason why isn't rendered (as you said) 'properly'. See documentation of render() method here.
I've updated your code so the name component is successfully rendered:

class Component extends React.Component{
  constructor(props){
    super(props);
  }

  render(){
    var Element = this.props.name;
    return (

      {Element}

    )
  }
}

const Dropdown = () =>{
    return(

       <select>
          <option value="initial" selected>Select...</option>
          <option value="grapefruit">Grapefruit</option>
          <option value="lime">Lime</option>
          <option value="coconut">Coconut</option>
        </select>

  )
}

class App extends React.Component {
  state = {
    components: []
  };

  render() {
    return (

        <Component
        components={this.state.components}
        name={
Dropdown
}/>

    );
  }
}

React.render(<App/> , document.getElementById('app'));

redpajama_set_name: RedPajamaStackExchange


Testing was carried out on our fully insulated 54mm commercial Tadpole on a primary school to show its ability to remove dissolved oxygen and reduce energy consumption.
Tralee Institute of Technology has a long standing committment to renewable energy and has a level 7 and 8 renewable energy management course. It is also pioneering renewable technologies through its facilities management group. It won a Sustainable Energy Ireland (SEI) energy award recently "Excellence In Coordinated Energy Management". This was the top prize in the category. Coupled with this the Engineering School has a strong research department and was recently awared a FP7 research grant of €1.7 million to develop energy efficiencies in milking parlour systems. This was achieved in conjunction with other European Institutions and Dairymaster Milking Systems.
This was a specific report consolidating all information related to the removal of oxygen and its effect on corrosion in the heating system.
Testing for dissolved oxygen under normal domestic heating cycle showed that the oxygen content of the heating water was reduced to an inert level after a weeks running from start up. Hot water recovery in hot water cylinder was improved and energy savings of 23.7% with Tadpole installed.