China Med Device

The NMPA released two documents to enhance the dynamic management of medical device classification on June 1, 2026. Issued as “Classification Adjustment Announcement” and the “Working Procedure for Dynamic Adjustment of the Medical Device Classification Directory”, these updates establish a more scientific, transparent, and risk-proportionate system for adjusting product cate...

To support the implementation of the IVD Reagent Classification Catalog issued in May 2024, NMPA issued a detailed interpretive guideline specifically for staining solutions. This guidance provides regulatory clarity for foreign manufacturers seeking to register their high-quality staining products in China. For “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnosti...

Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in June 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies 11 Class III Devices and 66 IVDs to be Newly Exempted from Clinical Trial NMPA published the “Clinical Evaluation Exempt Draft […]

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NMPA published seven guidelines on post-market surveillance for medical device manufacturers in April 2026. These documents establish a mandatory, risk‑based vigilance system under the Medical Device Vigilance Quality Management Standards (Trial), supported by detailed implementation guides for trend reporting, periodic safety update reports (PSURs), risk evaluation, vigilanc...

The NMPA granted innovation approval to B.Braun Avitum’s CRRT hemofilter and issued a review report. The published review reports like this one serve as important references for you to understand what the regulatory authorities are thinking and evaluating during their review process. We have been following the list for the past several years and review […]

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