Medical Device Single Audit Program (MDSAP)

The International Medical Device Regulators Forum (IMDRF) began work on developing documentation to facilitate the Medical Device Single Audit Program (MDSAP) in Singapore in 2012. The Pilot Program is now due to begin in 2014 and will bring a new era for medical device manufacturers. The global approach to consistent audit requirements is hoped to facilitate improved monitoring of devices and reduce burden for manufacturers.

The MDSAP is designed to ensure a single audit of a medical device manufacturer will provide efficient and thorough coverage of the diverse international regulatory requirements of medical device quality management systems, and other specific regulatory requirements. It represents an important milestone in regulatory cooperation and recognition.

The pilot MDSAP will allow MDSAP recognised auditing organisations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements for all regulatory bodies participating in the program.  The countries involved in the MDSAP currently includes the following:

• Australia: the Therapeutic Goods Administration (TGA)
• Brazil: The Brazilian National Health Surveillance Agency
• Canada: Health Canada
• USA: The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH)
• Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are official observers and active participants in the council however are not yet full participants.

Stay tuned for further updates on this exciting development.

For further information or guidance regarding external regulatory body audit contact KD&A.