Here’s the latest China 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 access.
Policies
China‘s New Draft of Medical Devices Biological Evaluation, in Full Alignment with ISO/FDIS 10993-1:2025
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” on August 21, 2025 for feedback. Feedbacks need to be submitted by September 20, 2025.
This draft represents the Chinese adoption of ISO/FDIS 10993-1:2025, aligning with internationally recognized framework for biological safety evaluation of medical devices. The main theme of the update is to avoid unnecessary biological testing and instead to evaluate safety using a risk management approach that incorporates multiple types of evidence, including chemical characterization, toxicological risk assessment, and scientific comparison with existing products. Click HERE for our full analysis
NMPA Proposes Updates to Medical Device Classification Catalog
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 submitted by September 10, 2025. The document demonstrates NMPA’s commitment to improve regulatory clarity and align the risk-proportionate oversight with global regulatory best practices. For device down-classifications and takeaways for overseas manufacturers, please click HERE
Insights from the 2024–2025 Classification Results: Opportunities for Imported Combination Products
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 device-led combination products. Several imported products have undergone evaluation, including both drug-led and device-led combination products. Click HERE for more information
QMS & PMS
Beckman Coulter Get Caught at NMPA Surprise Inspection: Equipment, Documentation, Design, Procurement, and Production Controls Show Deficiencies
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 or “fly inspections”, are carried out by provincial medical products administrations. This time it revealed widespread quality management weaknesses, including incomplete documentation, weak design controls, inadequate supplier oversight, and insufficient post-market vigilance. While most issues were categorized as general nonconformities, the recurrence of similar problems across multiple companies highlights systemic risks.
Worth mentioning is the overseas manufacturer Beckman Coulter, whose fully automatic biochemical analyzer and specific protein analyzer are cited for missing maintenance records, inconsistent forms, incomplete standards, inadequate risk analysis, poor material risk classification, unclear electrostatic protection. For the full list of manufacturers with violations, please click HERE
