On January 29th, 2024, Zybio Inc. received the MDSAP (Medical Device Single Audit Program) certificate issued by internationally authoritative certification body, BSI Group America Inc. This signifies that Zybio has officially completed the MDSAP certification for its quality management system.

This certification covers analytical instruments for detecting microbial infections and in vitro diagnostic reagents for diagnosing cancer, inflammation, infectious diseases, coagulation, cardiac markers, and microbial infections.

The certification indicates that Zybio's quality management system now meets the requirements of medical device regulatory authorities in the United States, Australia, Brazil, Canada, and Japan. This achievement will accelerate the entry of Zybio's products into the international market, facilitating the company's global development.

MDSAP Certification

MDSAP is a program initiated by the MADSAP Regulatory Authority Committee of IMDRF (International Medical Device Regulators Forum). It is recognized and joined by regulatory authorities in five countries: the United States (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC), and Japan (MHLW).

The recognition of MDSAP audit results by regulatory authorities in these five countries can help optimize the overall process of factory inspections and audits, saving audit time and resources, and reducing production disruptions caused by audits. MDSAP is one of the internationally recognized authoritative certifications.

The recognition levels by respective countries are as follows:

United States: MDSAP serves as an alternative to routine inspections by the FDA, excluding FDA special and PMA products.

Canada: Since 2019, MDSAP is mandatory and replaces CMDCAS, becoming the sole QMS certification pathway for products entering Canada classified as Class II and above.

Australia: MDSAP is eligible for exemption from TGA audits, supporting the issuance and maintenance of TGA conformity assessment certificates.

Brazil: For Class III and Class IV medical devices, MDSAP can substitute ANVISA's pre-market GMP inspections and post-market routine inspections (excluding special inspections).

Japan: Within the Japanese regulatory framework, both MHLW (Ministry of Health, Labour and Welfare) and PMDA (Pharmaceuticals and Medical Devices Agency) will utilize MDSAP audit reports for regular pre-market and post-market audits in Japan. For Class II, III, and IV medical devices, on-site factory audits can be exempted.

WHO: MDSAP is eligible for streamlining or exemption from on-site inspections for the qualification assessment of in vitro diagnostic devices by WHO.

Zybio has always adhered to the mission of "Accurate Diagnostics, Healthier Lifestyle". The acquisition of the MDSAP quality system certificate will not only accelerate the pace of global development strategy but also elevate the company's level of medical device quality management. Zybio has previously obtained various internationally renowned quality management system certifications, such as ISO13485, IVDR, NRTL, etc. In the future, Zybio will continue to provide high-quality products and services to more countries and regions globally, contributing to human health.