Sansure Celebrates Acquisition of MDSAP Certification
2024-03-14 yang, rongchang

Sansure Celebrates Acquisition of MDSAP Certification

Sansure Biotech Mar 14, 2024

From December 19th to 22nd, 2023, Sansure underwent a three-and-a-half-day MDSAP quantity management system certification audit. Through the close collaboration and joint efforts of various departments within the company, Sansure successfully passed this stringent audit and obtained the certification.


The MDSAP certification is not only a significant achievement for Sansure but also a key milestone in its internationalization strategy. This certification is a project jointly initiated by member countries of the International Medical Device Regulators Forum (IMDRF), aimed at enabling medical device manufacturers to meet the quality management system (QMS) and good manufacturing practice (GMP) requirements of participating countries through a single audit. Possessing the MDSAP certification means that Sansure’s products will gain access to key markets such as the United States, Canada, Brazil, and Australia without the need for additional system certifications. This not only greatly simplifies the process of entering these markets but also significantly enhances market access efficiency.


Under the organization of the Quality Management Department, all departments of the company demonstrated a high degree of unity and collaboration, giving full attention to the audit work. In preparation for this certification, the Quality Management Department began meticulous preparations at the end of 2022, established a special project team, and carried out extensive collection and interpretation of regulations. Based on an in-depth understanding of the regulations, a differential analysis of the quality management system was conducted, and a comprehensive revision of documents and system optimization followed. Through two internal audits in August and November, all preparations were ensured to be foolproof. On this well-prepared foundation, Sansure successfully passed the first and second certification audits in October and December, respectively.

The smooth acquisition of the MDSAP international system certification not only fully proves the completeness and effectiveness of Sansure’s quality management system but also significantly enhances Sansure’s competitiveness in the international market.

Looking ahead, Sansure will continue to commit to strengthening and improving its quality management system, continuously enhancing product quality and service levels, and is dedicated to providing global customers with higher quality products and services. We firmly believe that the MDSAP certification will help Sansure win more opportunities and trust in the global medical device market.

Stay tuned for more exciting performances by Sansure on the international stage.

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