Guidance of order 104 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, product risk file of 1. medical device; raw materials (when applicable), production processes (when applicable), analytical performance evaluation, positive judgment value or reference interval determination, stability validation, clinical evaluation, risk analysis file of 2. 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.
Annex: technical documentation of fast track (detailed req for payed gap analysis)
CH1.04 Application form
CH1.06 Quality management system, comprehensive quality system or other certification documents
CH6A.3.1 Product description information, CH6A.3.2 General production information (for medical devices) CH6B.6.3 Production and service control information (for in vitro diagnostic reagents)
CH3.4.1 List of standards (product technical requirements)
CH3.4.2 Declaration of conformity and/or certification
CH5.03 Label/instructions for use, CH5.02 Product/packaging label (for medical devices) CH5.3 Packaging instructions/instructions for use, CH5.2 Product/packaging label (for in vitro diagnostic reagents)
CH1.11.7 Declaration of conformity (for medical devices) CH1.11.6 Declaration of conformity (for in vitro diagnostic reagents)
Original resource (history)
Best practise
We have accompanied some manufacturers either to register „fast track“ approval of medical device or establish a production site with
Chinese GMP.
Here are some lessons learned:
Legal entity (updated in 2025):
A foreign-invested enterprise can be an enterprise established by the registrant of imported medical devices, or an enterprise with the same actual controller as the registrant of imported medical devices. That is, the foreign-invested enterprise established by the registrant of imported medical devices, or with the same actual controller as the registrant of imported medical devices, can produce the second and third category products with the imported medical device registration certificate within the territory of the People's Republic of China.
Production:
The foreign manufacturer must have own production entity in China. Outsourced production of medical device is not allowed.
Legal manufacturer of new Chinese products should produce medical device.
A design transfer bw R&D and Chinese production is complex.
Product technical requirements must be represented in
incoming -, in process – and final inspection of medical device. Otherwise a rational must be provided.
Registration:
Former
Chinese certificate must be valid at time point of product submission.
Among technical documentation submitted to authority, the critical process of production workflow should not be changed.
Type testing of medical device must be repeated in China.
Technical documentation
As listed above only 9 main chapters of TD are needed fr submission.
Do NOT forget that
- Chinese name of product can be differant than original one
- PTR/Type testing takes at least one year & CH 3.4.1
- Product must be compliant with obligatory Chinese standards (GB and YY)
Quality management system:
A Chinese conform quality management system must be established. Parallel to product registration a Chinese GMP must be certified by authority.
A big challenge is how to transfer
local QM system (ISO 13485 or QSR) to Chinese QM and how to have a
design transfer from headquarter of manufacturer?
Tactic:
Person in management level with
Chinese and overseas mind-set is asked. Chinese GMP and product registration must be at the same time prepared and approved. The interface between regulatory affairs, R&D, product management and production must be cleared defined in a multi-parties project management.
A
product variant to approved overseas medical device must be differentiated.
