ZR MedTech MDSAP Certification Approved
Recently, ZR MedTech successfully passed the Medical Device Single Audit Program (MDSAP) certification and received the MDSAP certification certificate issued by the internationally authoritative organization, BSI. This certification covers five countries: the United States, Japan, Brazil, Canada, and Australia.
Obtaining this quality management system certification will provide ZR MedTech with a more convenient pathway to global market access, helping to improve product quality, safety, market competitiveness, and international recognition. It will positively impact the company’s future expansion in international markets.
About MDSAP
The Medical Device Single Audit Program (MDSAP) is initiated by the International Medical Device Regulators Forum (IMDRF). Based on ISO 13485, it incorporates the regulatory requirements of the five participating countries (the United States, Canada, Brazil, Australia, and Japan). The program allows recognized auditing organizations to conduct a single audit to satisfy the requirements of multiple countries’ regulations.
Recognition of MDSAP in Participating Countries
●United States: Replaces routine FDA inspections, excluding FDA special and PMA products.
●Canada: Mandatorily replaces CMDCAS since 2019, serving as the only QMS certification path for Class II and above products entering Canada.
●Brazil: For Class III and IV medical devices, it can replace ANVISA’s pre-market GMP inspections and routine post-market inspections (excluding special inspections).
●Australia: Can exempt TGA audits, supporting the issuance and maintenance of TGA compliance audit certificates.
●Japan: For Class II, III, and IV medical devices, it can exempt on-site factory audits.
About BSI
The British Standards Institution (BSI) was founded in 1901 and received the Royal Charter in 1929, becoming the world’s first national standards body. It is also a founding member of the International Organization for Standardization (ISO). Today, it is a leading global provider of business standard services. Currently, 49% of the world’s Fortune 500 companies use BSI certification services. The certification certificates issued by BSI are internationally authoritative and widely recognized, earning the reputation as the “Source of Standards” in the industry.
ZR MedTech has always focused on scientific management. Previously, ZR MedTech obtained ISO 13485 medical device quality management system certification. Now, with the MDSAP certification, it further solidifies ZR MedTech’s leading position in quality management and product safety. It also facilitates the company’s entry into international markets, enhancing product competitiveness and international recognition.
In the future, ZR MedTech will continue to dedicate itself to global market expansion, continuously improving product quality and innovation capabilities, and providing high-quality medical solutions to more patients.