Congratulation! Unimed Obtains MDR CE Certificate

Unimed is thrilled to announce that our MDR CE certificate has been officially issued by TÜV SÜD. This marks a significant milestone in our MDR compliance program.

Unimed is thrilled to announce that TÜV SÜD has officially issued our MDR CE certificate. This marks a significant milestone in our MDR compliance program.

As a leading medical supplies manufacturer specializing in patient monitoring supplies and accessories, Unimed has passed ISO 13485:2016, MDSAP, Medical Device Directive 93/42/EEC, China’s Medical Device GMP, and other related regulatory and quality management system audits. Our products comply with regulatory standards from leading authorities across multiple regions, including CE marking for the EU, FDA 510k clearance for the US, NMPA certification for China, PMDA approval for Japan, and ANVISA certification for Brazil.

The Medical Device Regulation (MDR) (EU 2017/745) is a new regulation for medical devices in the European Union, which was entered into force in May 2017 to replace the Medical Device Directives (MDD) (93/42/EEC) and fully came into effect on May 26, 2021.

The EU MDR places a greater focus on clinical performance, better traceability, and greater patient transparency, posing greater challenges for medical device manufacturers. Compared to the MDD, the MDR imposes higher requirements in terms of product risk management, product performance and safety, pre-market clinical evaluation, and post-market vigilance and surveillance of products.

The issuance of the MDR certificate underscores Unimed's commitment to high standards in product quality, safety, and effectiveness. This achievement is a testament to Unimed's unwavering dedication to high-standard products and quality system management. Moving forward, Unimed will continue to uphold our core values and provide customers from Europe and all over the world with comprehensive, reliable, and compatible products, along with professional, fast, and exceptional services.