What MDSAP? The Medical Device Single Audit Program (MDSAP) to legally export to US and EU markets.

MDSAP - The Medical Device Single Audit Program
The International Medical Device Regulators Forum (IMDRF)External Link Disclaimer recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

MDSAP Members
- 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

MDSAP Official Observers:
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
- European Union (EU)

MDSAP Affiliate Members: (New)
- Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Republic of Korea's Ministry of Food and Drug Safety

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities.
Besides, Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards. The transition to the MDSAP was initially announced in December 2015 and was completed in 2019.

Organizations and enterprises desire register the Medical Device Single Audit Program (MDSAP) of certification CE Marking, please contact:

📶📶📶 Contact us to register for MDSAP/ CE mark certification.

Customers, organizations and enterprises require The Medical Device Single Audit Program (MDSAP) or CE marking Certification services, please click on "Registration - Quotation" or on the right toolbar below the PC screen to receive a quotation for training, consulting and certification services.

📶📶📶 Further information, please contact us as below:

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