What is Fast track approval in China?

Guidance of order 194 in 2020

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 to Encourage Innovation in Drugs and Medical Devices" issued by the General Office of the CPC Central Committee and the General Office of the State Council, implement the "delegation, regulation and service" reform and optimize the business environment requirements, comprehensively deepen the reform of the medical device review and approval system, promote the high-quality development of the medical device industry, and better meet the public health needs, the following matters are hereby announced regarding the production of products with imported medical device registration certificates by enterprises in China:

I. Scope of Application

This announcement applies to matters related to the production of Class II and Class III products with imported medical device registration certificates by foreign-invested enterprises established in China  by registrants of imported medical devices.

II. Registration Requirements

(I) Foreign-invested enterprises established in China by registrants of imported medical devices shall, as registration applicants, submit domestic medical device registration applications to the drug supervision and administration department. In principle, the content of the registration application, except for the name, residence and production address of the registrant, shall be consistent with the relevant matters stated in the corresponding imported medical device registration certificate and its attachments.

(II) The applicant shall submit the registration application materials in accordance with the requirements of the Announcement on the Requirements for Registration Application Materials and the Format of Approval Documents for Medical Devices (Announcement No. 43 of 2014 of the State Food and Drug Administration) and the Announcement on the Requirements for Registration Application Materials and the Format of Approval Documents for In Vitro Diagnostic Reagents (Announcement No. 44 of 2014 of the State Food and Drug Administration). Among them, the summary information, research information, clinical evaluation information, product risk analysis information of medical device products, the summary information, research information of main raw materials (when applicable), research information of main production processes and reaction systems (when applicable), analytical performance evaluation information, positive judgment value or reference interval determination information, stability research information, clinical evaluation information, product risk analysis information of in vitro diagnostic reagent products, and the original registration application materials of imported medical devices may be submitted. Import registrants and domestic registration applicants shall ensure the relevance and support of the above information to this registration application.

(III) The registration application procedure shall be implemented in accordance with the "Medical Device Registration Management Measures", "In Vitro Diagnostic Reagent Registration Management Measures" and relevant provisions on electronic submission of medical devices.

(IV) If the registration application is submitted and approved in accordance with the requirements of this announcement, the medical device registration certificate number of the relevant imported product that has been approved for registration shall be stated in the notes column of the registration certificate.

III. Quality management system verification requirements

The applicant shall ensure that the 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 product's domestic production quality management system complies with my country's "Medical Device Production Quality Management Standards" and a comparison report on the equivalence of domestic and foreign quality management systems. The drug regulatory authorities shall conduct a comprehensive review of domestic registration applicants in accordance with the medical device registration quality management system verification work procedures, focusing on the equivalence and traceability of domestic and foreign quality management systems, and whether the system changes brought about by the change of the production process will generate new risks and cause changes in registration matters.

IV. Post-market supervision requirements

Domestic registrants shall apply for medical device production licenses in accordance with the "Medical Device Production Supervision and Management Measures", strictly implement the main responsibility for quality and safety, and strengthen the quality management of medical devices throughout their life cycle; in accordance with the requirements of the "Medical Device Production Quality Management Standards", establish and improve the quality management system and ensure its effective operation.

V. Other aspects

For overseas registrants invested by Chinese enterprises that produce Class II and Class III medical devices in China that have obtained imported medical device registration certificates, this announcement shall apply for registration of the product.

For matters related to products that have obtained medical device registration certificates in Hong Kong, Macao and Taiwan, refer to this announcement.

This announcement shall take effect from the date of the announcement.