Certificates
CE 1250
EN 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
Europe
Medical Device Directive 93/42/EEC (MDD)
Annex V
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)