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Qualification

Accreditations

The company has developed over 140 certified Class II National Certificated Reference Materials and over 1,000 third-party quality controls. We have successfully guided medical device companies through the registration of more than 900 products.

Furthermore, the team has assisted companies within the Da'an Gene system and across the industry in obtaining over 900 medical device registrations, new drug certificates, and certifications. More than 80 of these projects are key achievements from major national initiatives under the Ministry of Science and Technology. The portfolio includes nearly 400 intellectual property rights and 164 products recognized as Guangdong High-Tech Products over the past three years.

Notably, of the 59 innovative medical devices approved by the National Medical Products Administration in 2019, 5 were supported by BDS. From the beginning of the year to November 31st, over 70 innovative devices received approval, with 8 of them facilitated by BDS' services.

Guangdong Engineering Technology Research Center for Biological Reference Materials
Guangdong Engineering Technology Research Center for Biological Reference Materials
Cooperative Institution
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Shanghai Free Trade One Life Science & Technology Park

The park integrates a full industrial chain of services in biopharmaceuticals, including CRO, CDMO, CSO, and EHS. It is dedicated to technology incubation in the healthcare sector and holds the distinction of being the first park in China to implement the Marketing Authorization Holder (MAH) system. Through pioneering reforms, it has established a comprehensive third-party platform for innovative technology transfer (CRO+CDMO+CSO) that specifically addresses the challenges in the R&D-to-market process for medical devices. This platform assists resident companies in obtaining regulatory approvals efficiently and compliantly, fostering their healthy and rapid development.

Shanghai Free Trade One Life Science & Technology Park

Suzhou BASECARE Medical Co., Ltd. (Stock Code: 02170.HK)

Suzhou BASECARE Medical holds the distinction of being the first company in China to successfully obtain cross-provincial product registration under the Marketing Authorization Holder (MAH) system. In 2020, the company secured the Class III Medical Device Registration Certificate for its Preimplantation Genetic Screening (PGS) product. This landmark certification directly facilitated its successful listing on the Main Board of the Hong Kong Stock Exchange in 2021, establishing the company as China's first publicly-traded entity in the Next-Generation Sequencing (NGS) sector for the assisted reproductive field.

Suzhou BASECARE Medical Co., Ltd. (Stock Code: 02170.HK)

Guangzhou Darui Biotechnology Co., Ltd. (Stock Code: 832705)

Darui Biotechnology obtained the Class III medical device registration certificate for its NIPT products and supporting gene sequencing instruments in 2014. In 2015, the company became the first listed enterprise in China’s second-generation sequencing (NGS) sector. During this period, the company’s valuation increased from RMB 120 million to RMB 2.4 billion.

Guangzhou Darui Biotechnology Co., Ltd. (Stock Code: 832705)

Successful Industrialization of Academic and Technological Achievements

Under the overall strategic planning of the project team, major parasitic disease prevention and control programs—including schistosomiasis led by Professor Pan Weiqing of the Second Military Medical University, clonorchiasis led by Professor Yu Xinbing of Sun Yat-sen University, and malaria and other parasitic diseases led by Southern Medical University—were successfully translated into registered medical devices by Darui Biotechnology. These projects were part of China’s National 973 Program and collectively won the Second Prize of the National Science and Technology Progress Award in 2017.

National Center for Disease Control and Prevention:

MERS-CoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)
Dengue virus nucleic acid detection kit (PCR-fluorescence probe method)
Zaire Ebola virus detection kit (PCR fluorescent probe method)

Universities and Academic Institutions:

Thalassemia Project led by Professor Xu Xiangmin, Southern Medical University

Industrialization of Major Special Projects of the Ministry of Science and Technology, Peking University Health Science Center Department of Peking University Health Science Center

Major National Scientific Instrument Localization Project, Tsinghua University

Projects led by Professor Xia Ningshao, Xiamen University

Other technology company projects:

Shanghai Tongshu MSI project; Guangzhou Guanhao artificial cornea project, Northwest Nonferrous Orthopedics Additive Manufacturing, Hangzhou Gates Foundation TB project, Beijing Dental New Material project……

Multinational company project:

KURABO CO., LTD、ILLUMINA、ThermoFisher、Agena.…