Mindray becomes the first Chinese company to obtain List A CE mark

2017-10-31
Mindray has received CE marking approval for its HIV and HBV CLIA (Chemiluminescence Immunoassay) test kits, making Mindray the first Chinese medical device company to receive List A CE marking for infectious diseases tests.

CE marking, or CE mark, indicates a product's compliance with EU Directives -- among which, 98/79/EC is the directive for IVD products -- to meet specific standards of performance, quality, safety, and efficacy, which enables the commercialization of the product in the European markets.

Mindray's CE applications, including HIV and HBV (HBsAg, Anti-HBs, Anti-HBc, HBeAg, and Anti-HBe) assays, were assessed by the German Red Cross and certified by T?V S?D, a Germany-based global certification body for medical devices. The certification announcement, attended by T?V S?D representatives, President of Department of Laboratory Medicine, Chinese Society of Laboratory Medicine, professor from China's renowned tumor hospital, as well as Mindray representatives, was held during the 13th National Laboratory Medicine Conference in Hangzhou, China, on Sept. 21st. 

Attendees at the announcement included (first left) Mr. Dirk von Wahl, President and CEO of T?V S?D North Asia, (second left) Mr. Haitao Huang, Vice President of Mindray Group, (third left) Dr. Boshen Pan, President of Department of Laboratory Medicine, Chinese Society of Laboratory Medicine, and (second right) Mr. Xuanyun Feng, Vice General Manager of Mindray Domestic Sales and Marketing.

"Infectious diseases tests are one of the most complicated and stringent CLIA assays due to complexity of samples and the existence of mutations. Over the last few years Mindray R&D team has been committed to tackling the difficulties and challenges. Now we have finally obtained CE certifications for these List A assays," Mr. Haitao Huang, Vice President of Mindray Group, said at the CE certification announcement."We have applied a number of patented technologies in the infectious disease assays to shorten the window period and reduce the endogenous interference of samples from pregnant women, the elderly, and patients with hepatic or renal diseases, etc." added Mr. Zhaoyang Li, General Manager of Mindray In-Vitro Diagnostics Business Unit. 


"This is a huge achievement for a Chinese medical device company, as not all manufacturers are able to fulfill the EU requirements," President and CEO of T?V S?D North Asia Mr. Dirk von Wahl stated at the announcement. The CE certification not only attests to Mindray's commitment to better healthcare solutions through continued technological advancement, "(Mindray) as the first Chinese company to receive List A CE marking, it also marks China's breakthrough in the CLIA infectious diseases testing area, " commented Dr. Boshen Pan, President of Department of Laboratory Medicine, Chinese Society of Laboratory Medicine. 


Behind Mindray's high quality products are its globally integrated innovation platform and world-class quality control system. Every year Mindray invests around 10% of its revenues in R&D to drive development of safe and dependable medical applications resulting in solutions that are trusted by customers worldwide and certified with international standards such as FDA and CE Marking. 

Mindray has established testing laboratories covering its wide range of products to ensure they are safe, effective and reliable in all medical applications. It has China's first independently-developed Standardization Lab where the whole IVD system -- including instruments, reagents, quality controls as well as calibrators -- can be traced back to international standards to guarantee the accuracy of test results. Mindray's Reference Lab and Standardization Lab have been certified by leading testing authorities worldwide, such as ILAC-MRA/CNAS, RELA, CAP, AAB and UK NEQAS. 

Mindray's Reference Lab is China's first testing lab certified by CNAS -- China National Accreditation Service for Conformity Assessment

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