IVD China last week: Mindray, YHLO, Mirxes

Turkey’s Minister of Health Kemal Memişoğlu Visits Mindray’s Shenzhen Headquarters with Delegation

On September 11th, Turkey’s Minister of Health, Kemal Memişoğlu, visited Mindray’s Shenzhen headquarters accompanied by a delegation. During the visit, the two parties discussed potential cooperation opportunities in areas including localized production, digital and intelligent transformation, industry-academia-research collaboration, international exchanges, and talent development.Minister Memişoğlu stated that based on their shared interests in the healthcare sector and our respective strengths, he believes their cooperation will not only achieve win-win results but also further enhance the health and well-being of the people of both countries.

Mindray first entered the Turkish market in 2000. Today, it has established 2 branches in Istanbul and Ankara, with local employees accounting for 90% of its workforce in Turkey. The company now serves over 1,300 medical institutions across the entire country.

Shenzhen YHLO Biotech Obtains IVDR CE Class D Certification for Two Products

YHLO announced on September 5th that two of its products have successfully obtained the IVDR CE highest risk class (Class D) certification formally issued by BSI Group The Netherlands B.V.

The acquisition of this certification marks that YHLO’s in vitro diagnostic reagents have met the world’s highest standards in terms of safety and effectiveness, further consolidating its leading position in the global IVD industry. It also confirms that the quality, safety and efficacy of YHLO’s products fully comply with the top-tier requirements of the EU’s In Vitro Diagnostic Regulation (IVDR), which will provide strong impetus for the sales and promotion of its products in the European market.

Singapore’s Early Cancer Detection Leader Mirxes Joins Southbound Trading, Deepening Ties with Chinese Capital

Mirxes, a Singapore-based RNA biotechnology firm and a leader in early cancer detection, was officially added to the list of underlying stocks for Southbound Trading under the Shanghai-Hong Kong Stock Connect on September 5th, and became available to mainland Chinese investors starting September 8th. This marks another milestone for the company, following its listing on the Main Board of the Hong Kong Stock Exchange in May—when its market capitalization exceeded USD 1 billion on the first day of trading—and signals strategic recognition of its early cancer detection technologies by the Chinese market.

Mirxes’ core products have gained strong traction in global markets. Its gastric cancer early detection product GASTROClear™ has been awarded the U.S. FDA Breakthrough Device Designation, a key recognition of its innovative value in clinical practice. Meanwhile, its lung cancer detection product LUNGClear™ generates significant revenue from Laboratory Developed Test (LDT) services in Southeast Asia and Japan, solidifying the company’s regional market position.

China-Russia Medical Technology Cooperation Center Launched in Pudong to Facilitate Export of Domestic Medical Devices

On September 11th, the "China-Russia Cooperation Center for Medical Technology and Equipment" Was Unveiled in Pudong. 

The Cooperation Center has set up this first Russian-authorized "Medical Device Registration Service Station" to simplify the registration process of China medical devices in Russia. Currently, Russia's annual demand growth for high-end medical consumables and IVD reagents reaches 35%, and in 2024, China's export volume of medical equipment to Russia exceeded 1.8 billion US dollars.

According to the plan, the Cooperation Center will provide comprehensive services for Chinese and Russian medical enterprises. Its key tasks include implementing Shanghai's interconnected interaction with the global community, introducing domestic and international medical technology innovation projects and high-end talents, and accelerating the global expansion of domestic medical device products.