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2026 China NMPA Bluebook is here:
The Shanghai Municipal Medical Products Administration issued the “Provisions on Transferring Medical Devices with Existing Registration Certificates into Shanghai Production” on August 14, 2025. The regulation will take effect on
Patent Background One of the patents for medium-term corneal preservation solution (Application No. CN200410091007.5, filed on November 15, 2004) was submitted by Shandong Eye Institute. The inventors include Dong Xiaoguang,
On June 27, 2025 NMPA approved the corneal preservation solution, developed by the team at Shandong First Medical University Affiliated Ophthalmic Hospital (Shandong Eye Hospital) and manufactured by Shandong Baiduoan
The NMPA National Institutes for Food and Drug Control released the draft GB/T 16886.1-2025, “Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process”
NMPA Center for Food and Drug Inspection issued the “Notice of Unannounced Inspections Results in 2nd batch of 2025” on August 15, 2025. The unannounced inspections, also called surprise inspections
The NMPA Center for Medical Device Standardization Administration issued the “Notice on Soliciting Opinions on Adjustments of the Medical Device Classification Catalog” on August 7, 2025. Feedbacks need to be
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market
NMPA Center for Medical Device Standardization Administration released “Drug-Device Combination Products Classification Results (June 2024 to May 2025) on July 7. The document identifies 7 drug-led combination products and 46
NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The new guideline offers regulatory clarity for market
The NMPA granted innovation approvals to Inari Medical’s FlowTriever Retrieval/ Aspiration System and issued a review report. The published review reports like this one serve as important references for you
NMPA published a draft document “Implementation Guideline for the Self-Testing Requirements of Medical Device Registration” on June 26, 2025 for feedback. Feedbacks need to be submitted by July 11, 2025.
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in July 2025. These updates are presented by China Med Device, LLC, your partner