How to be MDSAP audit ready

The MDSAP Audit Approach covers the requirements of:

• ISO13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes and the regulatory requirements from relevant MDSAP RAs (see ISO - ISO 13485 — Medical devices)
• the Australian Therapeutic Goods (Medical Devices) Regulations (2002) Schedule 3 Part 1, excluding 1.6, and Schedule 3 Part 4 
• the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013) 
• the Canadian Medical Devices Regulations (Parts 1 and 1.1)
• the Japanese QMS Ordinance (MHLW MO 169) 
• the American Quality System Regulation (21 CFR Part 820), and 
• other specific requirements of medical device regulatory authorities participating in the MDSAP program including 21 CFR Part 803 and 21 CFR Part 806.

Manufacturers will be audited to the jurisdictional regulatory requirements based on the countries where they sell or intend to sell or have devices registered. The MDSAP AO will determine which regulatory requirements are applicable and within scope of the audit in collaboration with the manufacturer.