China medical device regulations are under proposed change by the National Medical Products Administration (NMPA). The proposal is to replace the current regulation Order 739 by an Administration Law which has been released in draft format for public comment until September 28, 2024.
It will be first comprehensive law governing the development, production, operation, use, standards, classification, vigilance, and recall of medical devices in China. The draft consists of 11 chapters and 190 articles aimed at improving China’s medical device management system and promoting high-quality development in the industry.
Here are some key changes and highlights of the draft administration law to substitute the current China Medical Devices Regulations are presented below:
Product Management and Registration (PMR):
- Simplified Market Entry for Foreign Manufacturers: Foreign manufacturers can now apply for NMPA filing and registration certificates in China without needing prior approval from their home country. This change streamlines the market entry process for many companies, allowing China to potentially become the first market in their global strategy.
- Real-World Data (RWD) Usage: RWD is expected to transition from supporting evidence to primary evidence in clinical evaluations, highlighting its growing importance in the registration process. This shift will offer manufacturers faster time to market and reduced costs. To capitalize on this, manufacturers will need to adapt their regulatory strategies, investing in technologies to capture and analyze RWD effectively.
- Transfer of Registration Certificates: The new law will allow the transfer of registration certificates between companies. The transferee must have the capability to ensure the safety, effectiveness, and quality control of medical devices, as well as the ability to manage risks. Additionally, they must fulfill the obligations of the medical device registrant.
- Optimizing Standards Management: The Draft recommends setting up a National Medical Device Standards Committee responsible for developing and enforcing mandatory national standards for medical devices. It also proposes a mechanism to evaluate the implementation of these standards, allowing for timely revisions based on the evaluation results.
- Emphasis on Innovation: The NMPA is prioritizing product innovation both domestically and internationally. The draft reinforces China’s commitment to medical device innovation, including provisions for supporting clinical promotion and use of innovative devices, special and priority reviews, emergency approvals, and the development of international multi-center clinical trials.
- Generic Naming Consistency: The NMPA will focus on the management of generic names for medical devices, ensuring consistency with names used in medical insurance and customs. During registration, device names might become more generic and import inspections will be stricter.
- Classified Management of Registration Changes: Class I medical devices are subject to product filing management, while Class II and Class III medical devices are subject to product registration management. Changes in registration will be subject to classified management, and requirements for such changes are expected to become clearer.
- Renewal Applications: Applications for certificate renewal must be submitted 6-12 months before the expiration date.
- Professional Review Teams: The NMPA will establish a professional technical review team and implement measures to restrict evaluations by reviewers who do not meet requirements. This step aims to improve the quality and consistency of evaluations, reducing unreasonable demands from reviewers.
- Stricter Enforcement: The law strengthens the penalties for illegal activities, shifting from “regulations” to “management laws,” and will lead to more frequent inspections, enforcement, and stricter penalties post-market.
Post-Market Surveillance (PMS):
- Change of Legal Agent: The term “Legal Agent” will be replaced by “Domestic Responsible Agent” (DRA). The DRA must hold a production license or a Class III sales license to qualify.
- Enhanced DRA Responsibilities: The DRA will take on more responsibilities, including keeping records of every import and sale in China, which will be subject to classification based on their record-keeping practices.
- Medical Device Co-Vigilance System: A Medical Device Co-Vigilance System should be established, requiring manufacturers to pay more attention to monitoring adverse events after product launch, like drugs PV.
How to submit comments on China Medical Device Regulations Administration Law Draft
The draft is now open for public comments. The NMPA will thoroughly review and incorporate these comments. For issues that gather significant attention, the NMPA will organize discussions and conduct specialized research. Please provide your comments through the following channels:
Email: Send your feedback to zfsfgc@nmpa.gov.cn with the subject “Feedback on the Medical Devices Management Law” before September 28, 2024.
Further information on amendments to China Medical Device Regulations
Read the original announcement on China Medical Device Administration Law – draft for comments.
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