Medotex Awarded MDSAP Certification by SGS

Medotex Biotech (Hangzhou) Co., Ltd (hereafter “Medotex”), a leading Chinese IVD manufacturer, has recently been awarded the Medical Device Single Audit Program (MDSAP) certificate by SGS. This milestone marks that Medotex’s medical device quality management system now meets the regulatory requirements of multiple countries, laying a solid foundation for the company’s medical device products to enter global markets smoothly.

The certificate awarding ceremony was attended by Medotex’s Vice President of Operations, Cui Chunhua, and representatives by SGS Emma Li, including the National Medical Device Market Manager of the Management & Assurance Division.

The MDSAP program, based on ISO 13485, serves as a “golden key” for medical device manufacturers seeking global market access. With a single audit, companies can satisfy the regulatory requirements of the U.S. FDA, Health Canada, Brazil’s ANVISA, Japan’s PMDA, and Australia’s TGA. Through SGS support services, enterprises only need one audit to simultaneously obtain both MDSAP and ISO 13485 certificates, efficiently opening doors to multiple international markets.

In the medical device industry, the standard MDSAP certification process typically takes 6–8 months, with some projects taking even longer. During this audit, the SGS expert team conducted a thorough and detailed review of Medotex’s quality management system. Leveraging SGS’s professional auditing expertise, efficient coordination, and precise pre-assessment mechanisms, combined with Medotex’s robust and well-established system foundation, the entire process—from formal audit to certificate issuance—was completed in just three months, setting a new benchmark for MDSAP audit efficiency and accelerating the company’s global expansion.