FDA to Begin Pilot on Mutual Recognition of Foreign Government and Third-Party Medical Device Audits
The Food and Drug Administration signed on to an international pilot program to accept medical device inspections by foreign governments and third-party auditors, said the agency in a Federal Register notice (here). Through the Medical Device Single Audit Program (MDSAP) International Coalition Program, regulators in Australia, Brazil, Canada, and the U.S. will accept audits of medical devices conducted by each foreign government, as well as by third-party auditors recognized by the coalition. Japan is participating as an observer. In the U.S., FDA will accept MDSAP audit reports as substitutes for routine inspections -- inspections conducted “for cause” or as a “compliance follow-up” won’t be affected. MDSAP is targeting June 2014 for the beginning of the pilot, with an eye to 2017 for the beginning of the operational program, FDA said (here).
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During the pilot, only third-party auditors recognized by Health Canada will be eligible to provide audit reports. FDA said MDSAP will begin accepting audit organization applications in January 2014. The audits will confirm compliance with quality management system requirements found in ISO 13485:2003; the Brazilian Good Manufacturing Practices, FDA’s Quality System Regulation for medical devices; and other specific requirements of medical device regulatory authorities participating in the pilot, such as registration, licensing, adverse event reporting.
FDA said participating foreign governments will use the medical device regulator and third-party MDSAP audit reports as follows:
Australia -- Therapeutics Goods Administration. The MDSAP audit report will be part of the evidence of compliance with medical device market authorization requirements, unless the device is excluded or exempted from these requirements, or if current policy restricts the use of the MDSAP audit reports.
Brazil -- Agência Nacional de Vigilância Sanitária. ANVISA will use the MDSAP audit reports as evidence to support its pre-market and post-market assessment procedures.
Canada -- Health Canada. The audit reports will be used as part of Health Canada’s Canadian Medical Device Conformity Assessment System (CMDCAS) certification program. Once the pilot ends, Health Canada intends to use MSDAP to ensure compliance with quality management system requirements in Canada.
The MSDAP International Coalition Program is being conducted under the International Medical Device Regulators Forum (IMDRF), which also includes the European Union. More information on the pilot will be posted on IMDRF’s website (here).