NIM Hosts China–Singapore Workshop on Metrological Traceability and Regulatory Policy for IVDs

The National Institute of Metrology (NIM), China, together with Singapore’s Health Sciences Authority (HSA) and Economic Development Board (EDB), hosted the China–Singapore Workshop on Metrological Traceability and Regulatory Policy for In Vitro Diagnostics (IVDs) at NIM in April.

More than 50 representatives attended the workshop, including experts from the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA), the National Center for Clinical Laboratories of the National Health Commission, the Beijing Institute of Medical Device Testing, and nearly 30 leading IVD companies in China.

In his opening remarks, Dr. Qu Jifeng, Vice Director General of NIM, noted that the accuracy of IVD results is crucial to clinical decision-making and public health, and metrological traceability and science-based regulation are pillars supporting the high-quality development of the IVD industry. He hoped that the workshop could help build a regular exchange platform under the bilateral cooperation framework between NIM and HSA, and promote practical cooperation in areas such as mutual recognition of standards, technical collaboration, and support for exporting enterprises.

Dr. Teo Tang Lin, Director of Chemical Metrology Division, Health Sciences Authority (HSA), said that China and Singapore are highly complementary in clinical metrology and regulatory practice. She emphasized the growing importance of international collaboration against the backdrop of rapid global advances in healthcare. By fostering technical exchange, regulatory dialogue, and industry engagement, the workshop is expected to contribute to the high-quality development of the IVD sector both regionally and globally.

During the workshop, experts and industry representatives from China and Singapore gave presentations on technical foundations, regulatory policies, and the broader industrial ecosystem. Dr. Liu Qinde from HSA and Dr. Song Dewei from NIM introduced recent progress in IVD-related technologies and traceability systems, and discussed pathways toward international comparability and recognition of measurement results. Lv Yunfeng from the Center for Medical Device Evaluation, NMPA, and Dr. Jiang Naxin from HSA briefed participants on the latest IVD and medical device regulatory requirements in China and Singapore, offering guidance for companies pursuing regulatory-compliant product development. Hao Tian from Singapore’s EDB presented Singapore’s diagnostics ecosystem and related industrial policies.

Representatives from IVD companies also shared their experiences in regulatory coordination and market exploration in Southeast Asia. In the afternoon discussion session, representatives from nearly 30 leading Chinese IVD enterprises exchanged views with Chinese and Singaporean experts on issues related to regulatory alignment and market access.

Focusing on key issues such as mutual recognition of standards in the IVD industry, the workshop centered on three themes: metrological traceability, regulatory coordination, and industrial ecosystem development. It served as a platform for deeper exchange between the stakeholders from China and Singapore on IVD-related traceability and regulatory policy, and offered insights for Chinese IVD companies seeking more participation in the global healthcare market.