China New Biomedical Technology Regulations (Order No. 818) Enter into Force – Dual-Track System for Product Registration / Clinical Translation and Application Finally Takes Effect
In recent years, with the rapid development of cutting-edge biomedical technologies such as cell therapy, assisted reproductive technology, and brain-computer interfaces technology, a large number of enterprises have invested in R&D activities in related fields. Regulatory authorities have also been continuously exploring a dual-track regulatory framework for "drugs/medical devices" and "technologies". On November 29, 2024, the Standing Committee of the Seventh People's Congress of Hainan Province reviewed and adopted the Regulations on the Promotion of New Biomedical Technologies in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port. On January 24, 2025, the Health Commission of Hainan Province issued the Implementation Measures for the Translation and Application of New Biomedical Technologies in the Boao Lecheng International Medical Tourism Pilot Zone of the Hainan Free Trade Port (Provisional) (the aforementioned documents are collectively referred to as the "Hainan Boao Regulations"), under which a pilot program was launched in the pilot zone for the clinical study, translation and application of new biomedical technologies.
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