Applicable regulations As required, specify the applicable regulatory documents considered and against which the manufacturer claims compliance. For example, US 21 CFR 821 only applies if the manufactured devices are subject to device tracking. See the MDSAP Certification Document Requirements MDSAP AU P0026 section – 9 for specific considerations on the inclusion or exclusion of 21 CFR Part 820 as audit – criterion. Jurisdictions that are not pre-listed in the form may be added as an In “Other Jurisdiction”. such a case, the relevant Regulation(s) should also be specified. This is an overview of applicable Medical Device Regulations of MDSAP participating countries. Country-specific applicable Medical Device Regulations Australia , Schedule 3 Part 1 (excluding Part 1.6) Full Quality Assurance Procedure [if – design controls are part of the certification]; OR Schedule 3 Part 4 Production Quality Assurance Procedure [if design controls – are excluded from the certification] Brazil Federal Law n. 6360/76 and RDC ANVISA resolutions: (Good Manufacturing Practices) (Vigilance) (Vigilance) RDC ANVISA n. 56/2001 (Essential Requirements for Safety and Performance) Canada Part 1 – Japan , Article 4 to Article 68 PMD Act (as applicable) United States * (Quality System Regulation) (Medical Device Reporting) (Reports of Corrections and Removals) Subchapter H – (Registration and Listing) Subparts A to D – (Medical Device Tracking) (where applicable) * When United States requirements are audited, 21 CFR 820 is applicable unless it has been demonstrated to the Auditing Organization that the audited organization is exempt (by FDA regulation) from all Quality System Regulation requirements other than 21 CFR 820.180 and 198.
Applicable regulations As required, specify the applicable regulatory documents considered and against which the manufacturer claims compliance. For example, US 21 CFR 821 only applies if the manufactured devices are subject to device tracking. See the MDSAP Certification Document Requirements MDSAP AU P0026 – section 9 – for specific considerations on the inclusion or exclusion of 21 CFR Part 820 as audit criterion. Jurisdictions that are not pre-listed in the form may be added as an “Other Jurisdiction”. In such a case, the relevant Regulation(s) should also be specified. This is an overview of applicable Medical Device Regulations of MDSAP participating countries. Country-specific applicable Medical Device Regulations Australia , Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure [if design controls are part of the certification]; OR Schedule 3 Part 4 – Production Quality Assurance Procedure [if design controls are excluded from the certification] Brazil Federal Law n. 6360/76 and RDC ANVISA resolutions: (Good Manufacturing Practices) (Vigilance) (Vigilance) RDC ANVISA n. 56/2001 (Essential Requirements for Safety and Performance) Canada – Part 1 Japan , Article 4 to Article 68 PMD Act (as applicable) United States * (Quality System Regulation) (Medical Device Reporting) (Reports of Corrections and Removals) – Subchapter H (Registration and Listing) – Subparts A to D (Medical Device Tracking) (where applicable) * When United States requirements are audited, 21 CFR 820 is applicable unless it has been demonstrated to the Auditing Organization that the audited organization is exempt (by FDA regulation) from all Quality System Regulation requirements other than 21 CFR 820.180 and 198.
413_13e_How_to_complete_Basic_Data_of_MDSAP_audited_facility.docx