SugenTech Obtains MDSAP Certification in the US, Canada, and Brazil

[Asia Economy Reporter Lee Gwan-joo] SuzenTech announced on the 30th that it has obtained the Medical Device Single Audit Program (MDSAP) certification for three countries: the United States, Canada, and Brazil.

MDSAP is a system established by the International Medical Device Regulators Forum (IMDRF) to certify medical devices that meet safety and quality management standards through a single audit of international medical device manufacturing facilities to ensure the safety and quality of medical devices.

As the strictest certification system in the medical device field, obtaining this certification proves the credibility of quality. Currently, countries participating in MDSAP include the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).

Through obtaining the MDSAP certification, SuzenTech is expected to be fully or partially exempted from certification audits of medical device manufacturing facilities by regulatory agencies in the three countries. In the case of Canada, MDSAP certification is mandatory for sales.

A SuzenTech official stated, “By obtaining the certification, we have laid the foundation to further expand the basis for securing international reliability of in vitro diagnostic medical device quality systems and entering the global market,” adding, “We will also acquire certifications for Japan and Australia to accelerate overseas business expansion.”