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MDSAP single audit definition

MDSAP is a project co-sponsored by members of the International Forum of Medical Device Regulators (IMDRF). It aims to conduct a single audit of a medical device manufacturer by a qualified third party audit body to meet the different QMS/GMP requirements of participating countries.

The program has been approved by five regulatory agencies: the FOOD and Drug Administration (FDA) of the United States, Health Canada of Canada, TGA of Australia, ANVISA of Brazil, and MHLW of Japan, And on January 1, 2017, MDSAP was officially implemented and the inspection results were mutually recognized.

The advantage of MDSAP

MDSAP is audited by a third party and the medical device regulatory authority in the participating country can use this audit report as a basis for judgment. MDSAP not only reduces the need for routine inspections by regulators, but also allows them to share the same and reliable audit results. Because the regulatory authorities recognize the audit results of MDSAP, manufacturers can reduce the number of audit times corresponding to different regulatory authorities and reduce the production interference caused by the audit. MDSAP, so that the audit process of international standardization, reduce the burden of production enterprises.

MDSAP single audit definition

The advantage of MDSAP

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