Ustar's quality management system has passed the medical device single regulatory audit program (MDSAP), and obtained the MDSAP certificate issued by TÜV SÜD, one of the recognized auditing organizations. 

What is MDSAP?
The Medical Device Single Audit Program – or MDSAP – allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities (RAs). Countries that currently recognize MDSAP certificates include the USA, Brazil, Canada, Japan and Australia.

Exemptions for MDSAP certified medical device in five countries:

USA: Replace FDA regular inspection, except for FDA special inspection and PMA.
Canada: Replace CMDCAS, and become the only QMS access to Canada for medical device of Class II and above.
Brazil: Replace pre-market GMP audit and post-market routine inspection (except for special inspection) of ANVISA for medical device of Class III and IV.
Australia: Exempted from routine TGA audit, allows for issuance and maintenance of TGA Conformity Assessment Certificate.
Japan: Exempted from on-site audit for medical devices of Class II, III and IV. 

Over the past 17 years, Ustar has been committed to the development, manufacturing and sales of innovative point-of-care molecular diagnostics, and meanwhile the effectiveness and efficiency of the quality management system (QMS) through defined and documented quality policy. The completion of MDSAP certification indicates the compliance with multiple regulatory requirements, and the recognition of Ustar's QMS on an international scale.