Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in April 2025. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
China Expanded Qualification and Further Simplified Made-in-China for Foreign Manufacturers: 2025 Updates
The NMPA released a notice “Announcement on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices in China” on 18 March, 2025. Building on the 2020 framework, the updates expand eligibility, streamline registration process, and harmonize quality management system for foreign manufacturers to produce Class II and III imported devices in China, aligning with the nation’s commitment to high-level openness and high-quality industry growth. For our comprehensive review, please click HERE
Checkpoints Reveal How NMPA Inspects Your Clinical Trials
NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” on March 12, 2025. The trial version was released in June 2024. Key information includes clinical trial conditions and compliance, subject rights protection, clinical trial protocol, data recording, traceability, and reporting, management of trial devices, etc. Click HERE for the details
Guidelines & Standards
CMDE Asks Manufacturers’ Input on Four Guidelines
CMDE issued a notice on March 17 to solicit the content input on four registration review guidelines. “Domestic and international manufacturers, research institutions, and clinical institutions with relevant work experience are encouraged to participate”, says the CMDE.
The impacted devices include intravascular ultrasound diagnostic equipment, cardiac electrophysiological mapping equipment and accessories, cardiac pulsed field ablation equipment, laparoscopic surgical system. For more information including related manufacturers, please click HERE
QMS & PMS
Inspection on Foreign Manufacturers in 2024: Rise of Remote GMP Audits
China has implemented stricter requirements over medical device manufacturing and quality systems. Analyzing China’s 2024 inspection data for overseas manufacturers reveals three key developments: heightened post-pandemic scrutiny, the growing reliance on remote GMP audits, and enhanced interprovincial collaboration in quality inspections. Click HERE for our analysis
Featured Article
Expanding Opportunities in China’s Booming Cataract Treatment Market: A Gateway for Foreign Manufacturers
With a significant increase in cataract cases driven by an aging population and lifestyle factors, China’s cataract treatment sector is poised for substantial growth. This surge in demand for cataract surgeries and related medical devices presents a unique gateway for foreign manufacturers looking to expand their footprint in the country. Click HERE to explore the cataract trends in China, treatment options, the devices and equipment used in cataract surgeries, the competitive market environment, and the opportunities and challenges for foreign manufacturers.