Last February, the National Medical Products Administration, the National Health Commission, and the National Healthcare Security Administration jointly issued a notice on the implementation of the third batch of unique labeling for medical devices. more…
In order to further guide applicants in determining the specific clinical evaluation paths for their registration, the Medical Device Review Center has issued a notice for the release of clinical evaluation recommended paths for a new batch of specific products. This is based on the 2022 notices, “Notice on the Release of Clinical Evaluation more…
On May 21 2024, the China NMPA has announced the implementation of the revised Classification Catalog for In Vitro Diagnostic Reagents (the Catalog) in accordance with the Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739). This revision, aimed at enhancing the regulatory framework for in vitro diagnostic (IVD) reagents, is set to take effect on January 1, 2025. more…
On May 28, 2024, China NMPA approved the registration applications for four innovative products: the Implantable Deep Brain Stimulation (DBS) Electrode Lead Kit, the Dual-Channel Rechargeable Implantable DBS Pulse Generator Kit, the Dual-Channel Implantable DBS Pulse Generator Kit, and the Implantable DBS Extension Lead Kit. more…
Recently (June 3), the National Health Commission issued a Notice on Further Improving Mechanisms and Promoting the Transfer of Urban Medical Resources to County-level Hospitals and Urban-rural Grassroots (hereinafter referred to as the Notice). more…
In recent years, the government has issued a series of policies to encourage and promote the development of innovative medical devices and consumables. However, due to the fact that most innovative medical devices and consumables are not covered by medical healthcare security, it still brings many difficulties to the development of innovative products. more…
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New regulations released, new changes in commissioned production of medical devices
Recently, NMPA issued the Announcement (No. 38 of 2024) on Further Strengthening the Supervision and Management of Production Commissioned by Medical Device Registrants (hereinafter referred to as the Announcement), which will come into effect on June 1, 2024 more…
