MEDICAL DEVICE SINGLE AUDIT PROGRAM, MDASP

MEDICAL DEVICE SINGLE AUDIT PROGRAM, MDASP

The Medical Device Single Audit Program (MDSAP) is an integrated audit concept proposed by the International Medical Device Regulatory Forum (IMDRF). Its purpose is to unify the regulatory standards of medical device authorities in different countries and provide more efficient regulations. Verification procedures to respond to the global medical device market and speed up the medical products put into the market.

Medical device manufacturers participating in the MDSAP program only need to perform a single integrated audit and verification activity through a qualified third-party notified body. When the verification is passed, they can also obtain approval from the competent authorities of the five major participating member states. Including: TGA, ANVISA, Health Canada, FDA, MHLW and PMDA. Health Canada has planned to use the MDSAP program to replace the CMDCAS certificate, and the competent authorities of other member states may also replace the current audit and verification mechanism with the MDSAP program in the future. At present, MDSAP has been officially launched in 2017, and SGS is a qualified third-party notified body.

Certificate Verification Benefit

• Eliminate repetitive barriers when entering different regional markets

• Effectively reduce the burden on your company to cope with external audits

• Assist the company to expand the sales market

• Increase the speed the innovative medical products put into the market

• Improve the acceptance of audit results in different countries

• Simplify the complexity of the company's regulatory verification management

• More stringent medical device regulatory quality system verification is conducive to obtaining supply chain system recognition from major international manufacturers

Applicable industry

For manufacturers who intend to sell medical device products to Australia, Brazil, Canada, the United States, Japan and other countries

Training course

• MDSAP Five Countries Quality System Introduction Intensive Seminar

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