In order to further implement the State Council’s “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” and the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices” issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council
Implement the reform of “decentralization, management and service” and optimize the business environment requirements
Comprehensively deepen the reform of medical device review and approval system
Promote the high-quality development of the medical device industry
Better meet public health needs
The “Announcement of the State Food and Drug Administration on Matters Concerning the Production of Imported Medical Devices in Chinese Enterprises” (2020 No. 104) has been issued and will come into force on September 23, 2020
1. Scope of application
(1) Relevant matters concerning the domestic production of Class II and Class III products that have obtained the import medical device registration certificate by the registrant of the imported medical device through its foreign-invested enterprise established in China
(2) Products whose medical device registration certificate is within the validity period
(3) If the original import registration certificate has expired or been cancelled, this announcement is not applicable
(4) For overseas registrants invested by Chinese domestic enterprises to produce Class II and Class III medical device products in China that have obtained imported medical device registration certificates, this announcement shall be followed.
(5) For matters related to products that have obtained medical device registration certificates in Hong Kong, Macau, and Taiwan, refer to this announcement.
2. Main principles
Under the premise that the product design does not change, the quality system remains basically the same, and the safety and effectiveness of the product does not change significantly, the original registration application materials of some registered imported medical devices are approved, so as to optimize the corresponding review data requirements and avoid repeated submission of materials. The same applies to domestic enterprises investing in overseas enterprises and producing in domestic enterprises.
3. Whether it is applicable to the pilot work of the medical device registrant system
The purpose of the “Announcement” is to optimize the registration application materials for the production of imported medical device products in domestic enterprises within the framework of existing laws and regulations. Products should be produced by foreign-invested enterprises established in China by the registrant of imported medical devices. Production that does not fall within the scope of the pilot work of the medical device registrant system shall not be entrusted.
4. The relationship between the newly obtained registration certificate and the original imported medical device registration certificate
If the registration application is submitted and approved in accordance with the requirements of the “Announcement”, the registration certificate number of the original imported product that has been approved for registration should be stated in the remarks column of the registration certificate
The domestic medical device registration certificate and the original imported medical device registration certificate are independent of each other and managed separately.
5. Registration system verification requirements and post-market supervision requirements
The registration applicant shall ensure that domestic production includes the main production process of the product, and promise that the main raw materials and production process will not change, and provide a self-inspection report that the quality management system of the product produced in China complies with my country’s “Quality Management Standards for Medical Device Manufacturing” and a comparison report on the equivalence of domestic and foreign quality management systems. The drug regulatory department conducts a comprehensive inspection of domestic registration applicants in accordance with the medical device registration quality management system inspection procedures.
Domestic registrants should apply for a medical device production license in accordance with the “Measures for the Supervision and Administration of Medical Device Production”, strictly implement the main responsibility for quality and safety, strengthen the quality management of the entire life cycle of medical devices, and establish and improve the quality management system and ensure effective operation in accordance with the requirements of the “Medical Device Production Quality Management Regulations”.