Important MDSAP Updates

On August 6, 2024, the Audit Approach document under the Medical Device Single Audit Program (“MDSAP”) was updated to Version 009. As a reminder, MDSAP is a program that allows for a single regulatory audit of a medical device manufacturer’s quality management system (“QMS”) that satisfies the requirements of multiple regulatory jurisdictions. The program was initially launched as a pilot in 2012 and then became fully operational in 2016. The goal is to ensure appropriate oversight over a QMS while enhancing efficiency and minimizing regulatory burden in the industry. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. Any manufacturer can participate as long as its device falls under the jurisdiction of at least one participating Regulatory Authority and meets its QMS requirements.

The changes implemented in this latest update include the following:

• Edit or removal of certain Australian requirements (TGA) including the following areas:
  • Management – Task 5, Task 8
  • Device Marketing Authorization and Facility Registration – Task 1, Task 2, Task 3
  • Measurement, Analysis, and Improvement – Task 7, Task 12
  • Adverse Events and Advisory Notices Reporting – Task 1, Task 2
  • Purchasing – Task 5
  • Annex 4
• Removal of all references to MHLW MO169 (Japanese QMS requirements), which was harmonized to ISO 13485:2003, considering that now only the 2021 amendment is applicable (harmonization to ISO 13485:2016).

All medical device manufacturers are urged to explore the benefits of the MDSAP program to determine if it makes sense for your organization. The advantages of obtaining a report from a single MDSAP audit in place of various inspections by all member Regulatory Authorities across the world cannot be understated. 

If you would like a copy of the latest version of the MDSAP Audit Approach document, please reach out to us at PRP and we will be happy to send it to you. Also, if you need assistance with any Regulatory Compliance or Quality projects with respect to your medical devices, we are always here to help!