What is MDSAP certification?
Medical Device Single Audit Program (MDSAP) is a project jointly initiated by members of the international forum of medical device regulators (IMDRF). The purpose is that a qualified third-party audit institution can meet the different QMS/GMP requirements of the participating countries by conducting an audit on the medical device manufacturers.
　　
The project has been recognized by five regulatory agencies: FDA, Health Canada, TGA, ANVISA and MHLW. On January 1st, 2017, MDSAP was officially implemented and the inspection results were mutually recognized. At present, China and the European Union have joined the project as observers, and the World Health Organization has officially joined as observers.
　　
What is the relationship between ISO13485 and ISO14971 and MDSAP?　　
ISO13485 is the foundation of MDSAP, and the requirements of MDSAP are higher / more than those of ISO13485; Although the provisions of MDSAP regulations are not integrated into the requirements of ISO14971 terms, the certification Checklist (MDSAP public document) has incorporated the contents of ISO14971 standard into the detailed provisions of the audit requirements, thus reflecting the importance of risk management standards and the necessity of implementing the risk management system. In addition to ISO13485 and ISO14971 standard requirements, MDSAP also has the regulatory requirements of participating countries;
　　
What can the NEC do for you?　　
Assist the enterprise in establishing medical device quality management system as per MDSAP
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Assist the enterprise to meet the requirements of MDSAP on the original QMS
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Integrate the quality management system of enterprises and meet the requirements of regulations in each country
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Provision of MDSAP specific training services
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Provide MDSAP special pre-audit service
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Provide on-site escort service for MDSAP audit
　　
Can MDSAP be a complete substitute for the review by competent authorities in participating countries?　　
A: The acceptance of the MDSAP audit results does not mean that the competent authority waives its regulatory authority and may still conduct the audit when the competent authority deems it necessary. The level of recognition in the relevant countries is as follows:
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US: a substitute for FDA's routine inspections, excluding FDA specific and PMA products
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Canada: mandatory replacement of CMDCAS from 2019 as a route to Canada for products classified in class II and above
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Australia: exempt TGA audits, support issuing and maintaining TGA certificate of compliance audits
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Brazil: For class III and class IV medical devices, it may replace ANVISA's premarket GMP inspections, as well as post marketing routine inspections (which do not contain specialized inspections)
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Japan: for class II, III, and IV medical devices, an on-site plant audit may be exempted;