New Regulations on Approval of Medical Devices in China

On 31 August 2021, the State Administration for Market Supervision and Administration adopted the Administrative Measures for Registration and Filing of Medical Devices and the Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents (hereinafter referred to as the Measures), which took effect on 1 October 2021. These Measures are the supporting implementation documents of the Regulations on Medical Device Monitoring and Administration which represent an improvement and specification of the product approval system.

Special registration procedures

The Measures add a chapter on special registration procedures, which includes the procedures for emergency registration, innovative device registration, priority registration etc..

The Measures provide procedures for emergency registration of medical devices. The Authority may conduct emergency registration for medical devices that are required for public health emergencies and for which there are no comparable products in China or the product offering does not meet the requirements for public health emergencies.

A special approval is designed to promote research and innovation in medical devices. Medical device applicants that meet the following requirements may apply to use the innovative device registration procedures:

• The applicant holds the invention patent right for the core technology of the product in China or has obtained the patent right by technology transfer, and the application for the registration has been submitted within 5 years from the date of granting the patent; or the application for the invention patent for the core technology has been officially published, and the authority has issued a report stating that the core technical solution of the product is novel and inventive.
• The applicant has completed the preliminary research of the product and has a basic final product, the research process is authentic and controllable, and the research data is complete and traceable.
• The main working principle or mechanism of action of the product is the first of its kind in China, and the performance or safety of the product has been fundamentally improved compared with similar products and has significant clinical application value.

In addition, the Measures specify three cases for priority registration:

• Medical devices that have obvious clinical advantages for diagnosing or treating rare diseases or malignant tumors, or medical devices that have obvious clinical advantages for diagnosing or treating diseases for the elderly or children, or medical devices for which there is an urgent clinical need but no product of the same type has been approved for registration in China;
• Medical devices that have been included in national major scientific and technological projects or national major research and development programs;
• Other medical devices to which the priority registration procedure can be applied.

Improvements of Evaluation and Approval Systems

In addition to the above special registration procedures, the following mechanisms have been introduced or specified by the Measures.

Full implementation of the responsibility system for applicants.

The main responsibilities of medical device applicants are clarified. Medical device applicants should strengthen the quality management for the whole life cycle of medical devices and take responsibility for the safety, efficacy and quality control of medical devices throughout the process of development, manufacture, operation and use in accordance with the law.

Simplified requirements for application documents

For innovative medical devices that have not yet been launched in the home country (where the applicant is registered or where the production site is located), there is no need to submit approval documents from the home country so that the "globally new" products can be launched in China as soon as possible.

New regulations on "product development" stage

In the phase of product development, the applicant must work out the technical requirements of the product, product specification and labeling, conduct non-clinical studies on medical devices according to the application field and technical characteristics of the product. Non-clinical research including product chemical and physical properties research, biological properties research, electrical safety research, radiation safety research, bio-source material safety research, sterilization, sterilization process research, animal testing research, stability research, etc.. When registering or filing the medical devices, the products must be tested in accordance with the technical requirements. Only after that can the clinical trial or the application for registration or filing of medical devices be carried out.

Implied approval for clinical trials

The national "Device Review Centre" (the "Centre") shall review the accepted clinical trial applications. The decision to grant or deny approval of a clinical trial application shall be made within 60 days from the date of acceptance of the application, the result will be shown on the Center's website. Failure to notify the applicant after the deadline will constitute consent. In other words: Within 60 working days of acceptance of the clinical trial application and fee payment, the applicant may proceed with the clinical trial if no opinion from the Center was received, provided that the contact information and mailing address provided in advance are correct.

Extended clinical trials

If a medical device for the treatment of serious life-threatening diseases for which there is as yet no effective treatment is found to benefit patients according to medical observation, this device may be used free of charge for other patients with the same disease within the institution conducting the clinical trial of the medical device, even if these devices are still undergoing clinical trials. The corresponding data can be used for product registration.

Approval with conditions

For medical devices used to treat rare diseases or serious life-threatening diseases for which there is no effective treatment, or medical devices for public health and other urgent needs, the competent authority may make a conditional approval decision and specify the expiration date, post-marketing research to be continued, etc. in the approval certificate.