Single QMS Audit Program Pilot for Medical Devices Set for January 2014

Medical device market regulators in Australia, Brazil, Canada and the US are preparing to launch a pilot for their Medical Device Single Audit Program (MDSAP) in January 2014.

Participating regulators—the Australian Therapeutic Goods Administration (TGA), Brazil’s ANVISA, Health Canada and the US Food and Drug Administration—ultimately hope to develop the MDSAP into a system whereby medical device manufacturers undergo only one quality management system audit acceptable across multiple regulatory jurisdictions. Currently, device manufacturers have to show compliance with different quality system standards such as FDA Quality System Regulations in the US, ISO 13485 in Europe and Brazilian Good Manufacturing Practices (BGMP) in order to register their products in those markets.

The MDSAP would spur more widespread use of third-party auditors alongside regulatory inspectorates, according to the TGA, to enable governments to focus their resources on higher-risk devices and adverse events.

Although the MDSAP pilot involves only Australia, Brazil, Canada and the US, the program has the backing of the International Medical Device Regulators Forum (IMDRF), and additional IMDRF member countries are expected to join the MSDAP over the longer term.

The TGA will provide more details about the MDSAP pilot closer to the launch date.

Stewart Eisenhart

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