How does the MDSAP ensure effort is not duplicated for manufacturers that sell in multiple jurisdictions?

The MDSAP audit process was designed and developed not only to prevent duplication, but also to ensure that the program provides efficient and thorough coverage of the requirements of; Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485: 2016) and any corresponding section(s) of the Australian Therapeutic Goods (Medical Devices) Regulations (SR 236, 2002), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Canadian Medical Device Regulations (CMDR, Part 1), the Japanese QMS Ordinance (MHLW MO 169), the US Quality System Regulation (21CFR 820), and other country-specific requirements.

The MDSAP audit sequence follows a process approach and was designed and developed to allow the audit to be conducted in a logical, focused, and efficient manner. 

MDSAP AOs are required to create a facility profile in the online portal (REPs) for each facility audited. The profile is kept updated by the AOs. This allows for timely notification to RAs of a manufacturer’s participation or withdrawal from MDSAP.

Timely notification of MDSAP initial audit schedules by AOs will prevent the duplication of inspection/audit of medical device manufacturers participating in MDSAP. Additionally, adequate notification of situations where a medical device manufacturer no longer elects to participate in MDSAP will ensure that continued regulatory oversight is maintained by all participating RAs.