MDSAP – Medical Device Single Audit Program
What is it and who should participate?
Established by a committee formed by the International Medical Device Regulators Forum, this program was created so that a single regulatory audit of a medical device manufacturer could be conducted that would satisfy the relevant requirements of the regulatory authorities participating in the program.
International partners that are participating in the MDSAP include:
MDSAP Members (Regulatory Authorities)
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- U.S. Food and Drug Administration
UNITED STATES
In the United States, the FDA accepts the MDSAP audit reports as a substitute for FDA routine inspections. However, other inspections may still apply.
CANADA
It is important to note that to sell in Canada, a medical device company must be MDSAP certified. Manufacturers of medical devices in classes I, II and IV that want to apply for a medical device license must demonstrate the requirements of the Canadian Medical Devices Regulation. These manufacturers must also certify their management system to ISO 13485.
Who can participate?
Any medical device manufacturer may participate provided the product falls under the scope of one of the regulatory authorities. This is, if your product is sold in one of the participating countries, you are eligible to participate.
Perry Johnson Consulting can conduct both your ISO 13485 internal audit as well as your MDSAP audits.
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