For MDSAP only: Australia: Therapeutic (Medical Devices) Regulations 2002 Schedule 3, Part 1 - Full Quality Assurance System Which countries are you currently or Schedule 3, Part 4 - Quality Assurance System of Production planning to ship medical devices into? Brazil: Federal Law n. 6360/76 (i.e., What are the Applicable RDC ANVISA n. 16/2013 - Good Manufacturing Practices Jurisdictions and corresponding RDC ANVISA n. 23/2012 Medical Device Regulations?) RDC ANVISA n. 67/2009 - Vigilance RDC ANVISA n. 56/2001 - Essential Requirements for Safety and Effectiveness Canada: Medical Device Regulations SOR/98-282, Part 1 United States: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation 21 CFR Part 821 - Device Tracking Japan: PMD Act (J-QMS ordinance) MHLW MO169 For MDSAP only yes no Is there an existing GMP certificate issued by ANVISA in Brazil? For MDSAP only yes no Should TÜV SÜD conduct the MDSAP audit concurrently with other regulatory audits such as the European MDD? If applicable, what regulatory / industry standards are relevant to your company?
For MDSAP only: Which countries are you currently or planning to ship medical devices into? (i.e., What are the Applicable Jurisdictions and corresponding Medical Device Regulations?) Australia: Therapeutic (Medical Devices) Regulations 2002 Schedule 3, Part 1 - Full Quality Assurance System Schedule 3, Part 4 - Quality Assurance System of Production Brazil: Federal Law n. 6360/76 RDC ANVISA n. 16/2013 - Good Manufacturing Practices RDC ANVISA n. 23/2012 RDC ANVISA n. 67/2009 - Vigilance RDC ANVISA n. 56/2001 - Essential Requirements for Safety and Effectiveness Canada: Medical Device Regulations SOR/98-282, Part 1 United States: 21 CFR Part 803 - Medical Device Reporting 21 CFR Part 806 - Reports of Corrections and Removals 21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing 21 CFR Part 820 - Quality System Regulation 21 CFR Part 821 - Device Tracking Japan: PMD Act (J-QMS ordinance) MHLW MO169 For MDSAP only Is there an existing GMP certificate issued by ANVISA in Brazil? yes no For MDSAP only Should TÜV SÜD conduct the MDSAP audit concurrently with other regulatory audits such as the European MDD? yes no If applicable, what regulatory / industry standards are relevant to your company?