certificates

ISO 13485:2016

 

Australia

Therapeutic Goods (Medical Devices) Regulations 2002

Schedule 3, Part 4 - Production Quality Assurance Procedures

 

 

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

 

Japan

MHLW Ministerial Ordinance No.169 (2004) as amended by MHLW Ordinance No. 128 (2014) Articles 4 to 68

Japan PMD Act (as applicable)

 

United States

21 CFR Part 807 (Subparts A to D) - Establishment Registration and Device Listing

* 21 CFR Part 820 - Quality System Regulation

 

MDSAP Audit Model (Ed. 2, ISO 13485:2016), MDSAP Companion Document (Ed. 2, ISO 13485:2016)