FDA Audit Policy for Medical Devices: a Comprehensive Document

In the field of medical devices, the Medical Device Single Audit Program (MDSA) is accepted and even mandatory in some countries. The idea of the MDSAP is to perform a combination of system, product and process audits based on ISO 13485. The countries participating in the MDSAP are Australia (TGA), Brazil (ANVISA), Canada (Health Canada), the USA (CDRH) and Japan (Ministry of Health, Labour and Welfare). Through the MDSAP, various requirements for regulatory audits will be jointly covered. Audits are conducted by authorised audit organisations (AO).

What is the acceptance of the MDSAP?

The EU does not participate in the MDSAP, but has an observer status. Japan recognises MDSAP audits to reduce workloads and may waive on-site audits and then would switch to Distant Audits. For Canada, MDSAP audits are mandatory (Class II, III, and IV products). In Australia, the MDSAP is the framework to recognize authorisations from the EU, Canada, and Japan, thereby avoiding duplicate audits. Brazil uses MDSAP audits for issuing GMP certificates. The FDA accepts MDSAP audit reports, but not as part of "for-cause" inspections, "compliance-follow ups," and pre- and/or post-approval inspections.

Although not fully recognised, the FDA has issued a very comprehensive "Policy" entitled "MDSAP Audit Approach". The document consists of a total of 215 pages. It contains specific instructions for conducting audits within the MDSAP programme. An audit sequence, details on how to audit each specific process according to the MDSAP, and links for interaction between processes are included. Red "boxes" are used to illustrate relationships of a specific process and the associated risk.

The audit sequence follows the four main processes

  • Management
  • Measurement, Analysis and Improvement
  • Design and Development
  • Production and Service Provisions

These processes are linked to other auxiliary processes, the purchasing process, marketing authorisation and registration, as well as adverse events and additional information. The 215-page document also includes five annexes. Annex 1 describes country-specific information regarding audits, and Annex 2 contains expectations for sterile medical devices during an audit. Annex 3 contains an overview of various reports in tabular form, and Annex 4 contains further explanatory information regarding regulatory requirements. Annex 5 contains a tabular comparison of the old and new Japanese QMS regulations.

For more detailed information please also see the Policy Title: MDSAP Audit Approach.

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