In order to implement the Opinions on Reforming the Review and Approval System for Drugs and Medical Devices issued by the State Council and the Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices issued by the General Office of CPC Central Committee and General Office of the State Council, implement the reform of “Decentralizing, Management and Service” and the requirements for improving the business environment, comprehensively deepen the reform of the evaluation and approval system for medical devices, promote the high-quality development of the medical device industry, and better meet the public health demands, the matters concerning the production of products with imported medical device registration certificate by enterprises in China are announced as follows:
I. Scope of Application
The matters concerning to production of Category II and Category III products with imported medical device registration certificates in China by the registrants of imported medical devices via the foreign-invested enterprises set up in China are applicable to this notice.
II. Registration Requirements
(I) As the registration applicant, the foreign-invested enterprise set up in China by the registrant of imported medical devices submits the application for medical device registration in China to the drug supervision and administration department. The application for registration shall be consistent with the relevant matters specified in the corresponding registration certificate of imported medical devices and its annex in principle except the name, domicile and production address of the registrant.
(II) The registration applicant submits the registration and declaration materials according to the Notice on Requirements for Registration and Declaration Materials and Format of Approval Documents for Medical Devices (Notice No. 43 of State Food and Drug Administration in 2014) and the Notice on Requirements for Registration and Declaration Materials and Format of Approval Documents for IVD Reagents (Notice No. 44 of State Food and Drug Administration in 2014). For the review data, research data, clinical evaluation data, and product risk analysis data of medical devices, the review data of IVD reagents, research data of main raw material (where applicable), research data of main production process and reactor system (where applicable), analytical performance evaluation data, cut-off value or reference interval determination data, stability research data, clinical evaluation data and product risk analysis data, the original registration and declaration data of the imported medical devices can be submitted. Both the import registrant and the domestic registration applicant shall guarantee that the above data is relative and supportive to this application for registration.
(III) The registration and declaration procedures shall be implemented according to the Measures for Registration Management of Medical Devices, Registration Management of IVD Reagents, and related regulations on electronic declaration of medical devices.
(IV) For the registration application submitted and approved as per the Notice, the registration number of the imported products that have been approved for registration shall be indicated in the remarks column of the registration certificate.
III. Verification Requirements for Registration System
The registration applicant shall guarantee the main production process for domestic production including products, promise no changes in the main raw materials and production process, and provide the self-inspection report on the quality management system for domestic production in line with China's Specifications for Production Quality Management of Medical Devices and the equality comparison report of domestic and foreign quality management system. The drug regulatory department shall verify the working procedures in accordance with the quality management system for medical device registration, comprehensively check the domestic registration applicants, and focus on the equality and traceability of domestic and foreign quality management system as well as new risks caused by system changes resulting from changes in production process, resulting in changes in registered particulars.
IV. Post-market Regulatory Requirements
The domestic registrant shall apply for production license of medical devices according to the Measures for Supervision and Administration of Production of Medical Devices, implement the entity responsibility for quality and safety, and reinforce the full life cycle quality management of medical devices; establish a sound quality management system and guarantee its effective operation according to the Specifications for Production Quality Management of Medical Devices.
V. Others
The production of Category II and Category III medical devices with imported medical device registration certificates in China by an overseas registrant invested by a Chinese enterprise shall be carried out with reference to the Notice. The Chinese enterprise investing in an overseas registrant shall apply for the registration of the product as the registration applicant.
Matters concerning to products that have obtained medical device registration certificates in Hong Kong, Macao and Taiwan shall be carried out with reference to the Notice.
The Notice shall come into effect as of the day of release.
Annex: Requirements for Registration and Declaration Materials of Medical Devices/IVD Reagents
(Please visit the Chinese website of CAMDI for details of the Annex)
National Medical Products Administration
September 18, 2020
I. Scope of Application
The matters concerning to production of Category II and Category III products with imported medical device registration certificates in China by the registrants of imported medical devices via the foreign-invested enterprises set up in China are applicable to this notice.
II. Registration Requirements
(I) As the registration applicant, the foreign-invested enterprise set up in China by the registrant of imported medical devices submits the application for medical device registration in China to the drug supervision and administration department. The application for registration shall be consistent with the relevant matters specified in the corresponding registration certificate of imported medical devices and its annex in principle except the name, domicile and production address of the registrant.
(II) The registration applicant submits the registration and declaration materials according to the Notice on Requirements for Registration and Declaration Materials and Format of Approval Documents for Medical Devices (Notice No. 43 of State Food and Drug Administration in 2014) and the Notice on Requirements for Registration and Declaration Materials and Format of Approval Documents for IVD Reagents (Notice No. 44 of State Food and Drug Administration in 2014). For the review data, research data, clinical evaluation data, and product risk analysis data of medical devices, the review data of IVD reagents, research data of main raw material (where applicable), research data of main production process and reactor system (where applicable), analytical performance evaluation data, cut-off value or reference interval determination data, stability research data, clinical evaluation data and product risk analysis data, the original registration and declaration data of the imported medical devices can be submitted. Both the import registrant and the domestic registration applicant shall guarantee that the above data is relative and supportive to this application for registration.
(III) The registration and declaration procedures shall be implemented according to the Measures for Registration Management of Medical Devices, Registration Management of IVD Reagents, and related regulations on electronic declaration of medical devices.
(IV) For the registration application submitted and approved as per the Notice, the registration number of the imported products that have been approved for registration shall be indicated in the remarks column of the registration certificate.
III. Verification Requirements for Registration System
The registration applicant shall guarantee the main production process for domestic production including products, promise no changes in the main raw materials and production process, and provide the self-inspection report on the quality management system for domestic production in line with China's Specifications for Production Quality Management of Medical Devices and the equality comparison report of domestic and foreign quality management system. The drug regulatory department shall verify the working procedures in accordance with the quality management system for medical device registration, comprehensively check the domestic registration applicants, and focus on the equality and traceability of domestic and foreign quality management system as well as new risks caused by system changes resulting from changes in production process, resulting in changes in registered particulars.
IV. Post-market Regulatory Requirements
The domestic registrant shall apply for production license of medical devices according to the Measures for Supervision and Administration of Production of Medical Devices, implement the entity responsibility for quality and safety, and reinforce the full life cycle quality management of medical devices; establish a sound quality management system and guarantee its effective operation according to the Specifications for Production Quality Management of Medical Devices.
V. Others
The production of Category II and Category III medical devices with imported medical device registration certificates in China by an overseas registrant invested by a Chinese enterprise shall be carried out with reference to the Notice. The Chinese enterprise investing in an overseas registrant shall apply for the registration of the product as the registration applicant.
Matters concerning to products that have obtained medical device registration certificates in Hong Kong, Macao and Taiwan shall be carried out with reference to the Notice.
The Notice shall come into effect as of the day of release.
Annex: Requirements for Registration and Declaration Materials of Medical Devices/IVD Reagents
(Please visit the Chinese website of CAMDI for details of the Annex)
National Medical Products Administration
September 18, 2020