After 3 years of public consultation, China’s National Medical Products Administration (NMPA) published the revised regulation on the Supervision and Administration of Medical Devices on 19 March 2021 (Ref. FGWJ-2021-10001). The Regulation will come into effect on 01 June 2021.
The revision of the Regulation is based on the following principles:
• Reform the requirements for the medical device testing and approval and strengthen the primary responsibility of manufacturers;
• Optimize the approval and submission procedures and provide incentives for innovative medical devices;
• Strengthen the entire life cycle management of medical devices, specifically post-market surveillance, and improve regulatory effectiveness;
• To increase penalties and cost for violations of the Chinese law.
The new Regulation introduces the following changes:
1. Introduced the new terms Registrant and Filer
Medical devices are categorized based on their risk posed to the users and/or patients and managed/controlled according to their categories. Class II and III medical devices must obtain marketing authorization, while Class I medical devices only need to be listed with provincial or municipal administration. To better monitor medical device manufacturers of different risk classes, the new Regulation introduces two terms: Registrant and Filer which stand for Class II and III device manufacturers Class I device manufacturers, respectively. Both terms are synonymous with the role of “marketing authorization holder” used for pharmaceutical manufacturers, who has the corresponding responsibilities and obligations throughout the product life-cycle. The Regulation includes a list of requirements for Registrant and Filer.
2. Simplified the processes for registration and listing of medical devices
Manufacturers are allowed to submit their internal test report as part of the submission file. This is a significant change, replacing the previous requirement that the test report must be issued by an accredited test laboratory in China. This change would greatly benefit foreign manufacturers and accelerate their marketing in China.
3. Clarified clinical requirements related to clinical evaluation and/or clinical investigation
a) A separate clinical evaluation guide will be published with clear circumstances and requirements for medical devices that are exempted from clinical evaluation. It will improve the efficiency of device registration applications.
b) Medical facilities are encouraged to carry out clinical investigations, i.e. the capacity and capability to conduct clinical investigation will be included in the qualification audit of medical facilities.
c) Enabling exploratory clinical testing, i.e. medical devices that undergo clinical investigation can be used free of charge for other patients with the same condition, and their safety data can be used for medical device registration applications.
4. Provided detailed requirements for single-use devices
Introduction of the requirements for single-use devices and their reprocessing. These requirements are similar to the requirements of the EU MDR.
5. Reduced the review period for production license application
The review period for production licenses is shorten to 20 working days from 30 working days.
6. Introduced several special fast review and approval procedures for medical devices registration
To respond to major public health emergencies, the Regulation establishes the following system to improve medical device review and approval:
a) The priority review and approval system:
It applies to innovative medical devices.
b) The approval system with conditions:
It applies to medical device for the treatment of rare diseases and serious life-threatening diseases for which an effective treatment is not available, and medical devices for the response to public health events and other urgent events.
c) The emergency use system:
It provides for the emergency use of medical devices in a specified scope and time period for particularly serious public health emergencies or other serious threats to public health.
d) The system of urgent clinical need for special import permit:
It applies to medical facilities that need to import a small number of Class II, Class III medical devices due to an urgent clinical need. Medical facilities can apply for a permit directly to the Supervision and Administration departments of provinces, autonomous regions and municipalities under the central government.
e) The medical and health institutions can develop medical equipment system:
Medical and health institutions to respond to public health emergencies may develop medical devices themselves in accordance with guidelines issued by the NMPA in cooperation with the national health department.