Policies
NMPA Proposes New Inspection Guideline for Medical Device GMP
The NMPA released the Draft Guideline for Inspection under the Medical Device Good Manufacturing Practices on June 9, 2026 for feedback. This draft represents a major step toward risk‑based, lifecycle‑oriented regulation of medical device manufacturing in China. It lists 39 critical check items that must be strictly controlled to maintain compliance. Click HERE for our comprehensive analysis
NMPA Refines Medical Device Classification Adjustment Framework with Detailed Interpretation
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 transparent and risk-proportionate system for adjusting product categories, management attributes (medical device vs. non-medical device), and risk classes. Click HERE to read
NMPA Official Interpretation Provides Regulatory Clarity for IVD Staining Reagents Classification
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 the rationale to define Class I and Class II staining solutions, please click HERE
Guidelines & Standards
NMPA Released Four Devices Guidelines
NMPA published four draft registration guidelines on June 3, 2026. They are aimed at facilitating manufacturers with clarity in technical documentation, performance testing, clinical evaluation, and labeling requirements. Three of the four guidelines target Class III high-risk devices (the various ablation systems), while the endoscopic imaging guideline addresses Class II devices—yet still carries significant compliance weight due to its detailed image quality and latency standards. Click HERE for the guidelines list and the reason why overseas manufacturers should pay close attention.