Karl Zhang
On February 9, 2021, the State Council promulgated the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), which will go into effect on June 1, 2021. The Regulations are highlighted as follows:
1. Categorized administration of medical devices
The state’s administration of medical devices is based on their risk categories. Class I medical devices are lower risk devices whose safety and effectiveness can be ensured through routine administration. Class II medical devices are medium risk devices that require strict control to ensure their safety and effectiveness. Class III medical devices are higher risks devices that require strict controls and special measure administration to ensure their safety and effectiveness. Class I medical devices are subject to product recordation administration, while Class II and Class III medical devices are subject to product registration administration.
2. Production registration and recordation of medical devices
The following materials shall be submitted for the recordation of Class I medical device products and for the registration of Class II and Class III medical device products: (1) product risk analysis information; (2) product technical requirements; (3) product inspection reports; (4) clinical evaluation materials; (5) product manuals and label samples; (6) quality management system documents relating to product development and production; and (7) other materials that relate to the safety and effectiveness of the products. For the recordation of Class I medical device products, the recordation applicant shall submit the recordation materials to the pharmaceuticals supervision and administration department of the people’s government of the local city with districts. For the application to register Class II medical device products, the registration applicant shall submit the registration application materials to the pharmaceuticals supervision and administration department of the people’s government of the local province, administrative region or municipality under the direct jurisdiction of the State Council. For the application to register Class III medical device products, the registration applicant shall submit the application materials to the pharmaceuticals supervision and administration authority of the State Council.
In case of substantial changes to the design, raw materials, manufacturing process, scope of application, and usage method of a registered Class II or Class III medical device product to the extent that its safety and effectiveness may be affected, the registration applicant shall apply to the original registration authority for amending the registration; and in case of other changes, they shall be recorded or reported pursuant to the requirements of the pharmaceuticals supervision and administration authority of the State Council. A medical device registration certificate is valid for a term of five years. If a renewal is required upon expiration, the registration renewal application shall be filed with the original registration authority six months prior to expiration.
The registration and recordation of medical device products should be subject to clinical evaluation, but may be exempt with any of the following circumstances: (1) the mechanism of work is clear, the design is fixed, the manufacturing process is mature, the same type of medical device has been marketed and clinically used for many years without any serious adverse effect, and the routine application is not changed; and (2) the safety and effectiveness of the medical device can be substantiated through no-clinical evaluation. The safety and effectiveness of the medical device may be proven through a clinical evaluation of the device conducted through a clinical trial based on the characteristics, clinical risks and existing clinical data of the product, or otherwise via analysis and evaluation of the literature materials and clinical data of the same type of medical device. However, pursuant to the requirements of the pharmaceuticals supervision and administration authority of the State Council, when conducting a clinical evaluation of a medical device, if there are insufficient existing clinical literature materials and clinical data to confirm the safety and effectiveness of the medical device, a clinical trial shall be conducted.
3. Production of medical devices
The production activities of medical devices shall meet the following conditions: (1) there are appropriate production sites, environmental conditions, production equipment and professional technicians for the production of the medical devices; (2) a quality inspection institution or dedicated examiners and examination equipment are available for conducting quality inspection of the medical devices; (3) there is a control system for quality assurance; (4) appropriate post-sale service capabilities for the medical devices; and (5) satisfaction of product development and manufacturing processes documentation requirements for.
To produce Class I medical devices, a recordation with the pharmaceuticals supervision and administration department of the people’s government of the local city with districts is required, which is completed upon the submission of the relevant materials that comply with the conditions under Article 30 of the Regulations. For Class II or Class III medical devices, a production permits from the pharmaceuticals supervision and administration department under the people’s government of the local province, autonomous region or municipality under the direct jurisdiction of the State Council is required, along with the submission of the relevant documents that comply with the conditions under Article 30 of the Regulations and the registration certificate for the medical device. The term of a medical device production permit is also five years, and if renewal is desired, the formality shall be conducted pursuant to the legal requirements for administrative approval.
4. Operation and usage of medical devices
For operating a Class II medical devices business, the operating enterprise shall make a recordation with the pharmaceuticals supervision and administration department of the people’s government of the local city with districts and submit the relevant materials that comply with the conditions under Article 40 of the Regulations. For Class III medical devices, the operating enterprise shall apply to the pharmaceuticals supervision and administration department of the people’s government of the local city with districts for an operating license and submit the relevant materials that comply with the conditions under Article 40 of the Regulations. The term of a medical device operating license is five years. If the term should be renewed upon expiration, and if renewal is desired, the formality shall be conducted pursuant to the legal requirements for administrative approval.
An entity that uses medical devices is required to have a corresponding storage site and qualifications appropriate for using the types and quantities of medical devices. It should enhance the technical training of its workers and require the use of medical devices in accordance with the product manuals and technical specifications and other requirements.
5. Handling of adverse events and recalls of medical devices
Medical device registrants and recordation applicants shall establish a medical device adverse event monitoring system, deploy adverse event monitoring institutions and personnel appropriate for the products, actively monitor product adverse events, and report the status of its investigation, analysis, evaluation, and product risk control to technical institutions monitoring medical device adverse events in accordance with the requirements of the pharmaceuticals supervision and administration authority of the State Council. Medical device manufacturers and those that operate a medical device business as well as the entities that use those devices shall assist the medical device registrants and recordation applicants in the monitoring of the adverse events of such medical devices. In the event of any actual or suspected adverse event concerning the medical devices, it shall be reported to the technical institution monitoring medical device adverse events pursuant to the requirements of the pharmaceuticals supervision and administration authority of the State Council.
6. Supervision, inspection and legal liability
The department responsible for pharmaceuticals supervision and administration shall enhance its supervision and inspection of the quality of medical devices in their research and development, production, business operation activities and use cases. It shall also enhance the random inspection of the registrants, recordation applicants, the medical device production and business operation enterprises and the user entities with respect to the production, business operation and use of the medical devices. In addition, the Regulations have stipulated penalties for production of or engaging in business operation regarding medical devices without a corresponding recordation or a registration certificate for those medical devices, such as the confiscation of illegal proceeds, fines, revocation of licenses, industry bans.