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MDSAP Council Updates Guidance on Conformity Assessments and Related Requirements

The participating regulators in the medical device single audit program (MDSAP) issued a new guidance documents that is consolidated from two existing documents and expanded with additional annexes.

Person doing an audit.

November 4, 2020

Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document​ into a single source of information detailing the process for auditing the quality management systems of medical device manufacturers.

Annexes provide information on processes, reporting deadlines, and agreement requirements

The MDSAP Council also added annexes providing further details and guidance on assessing conformity for each audited process; giving deadlines for submitting adverse events reports and advisory notices; and outlining requirements for written agreements between manufacturers and suppliers, with references to key clauses from international medical device quality management standard ISO 13485:2016.

The new annexes are titled as follows:

  1. Audit of Product/Process related Technologies and Technical Documentation
  2. Audit of Requirements for Sterile Medical Devices
  3. Medical Device Adverse Events and Advisory Notices Reporting Process Quick Reference
  4. Requirements for Written Agreements

Annex 4 provides additional detailed country-specific requirements pertaining to Australia.

MDSAP background and current adoption status

MDSAP is an international audit program based on a model drawn up by the International Medical Device Regulators Forum (IMDRF), with participation from the relevant regulatory bodies of five nations: the US FDA, Health Canada, Australia’s TGA, Brazil’s ANVISA, and Japan’s MHLW and PMDA. The US is the leader in the number of MDSAP certifications, but the last year has seen steady adoption in markets such as Brazil. The European Union is currently working out the details of implementing MDSAP among its member nations.

MDSAP AU P0002.005 became effective immediately upon publication.

Learn more about MDSAP at Emergo by UL:

  • MDSAP internal and gap audits

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