1. Brief summary of the fast-track application mode under the 2020 Announcement
For those registrants of imported medical device who have obtained the certificates of registration for imported medical device for Class II and/or Class III products, their foreign-invested enterprises established in China are entitled to apply for the registration of domestic medical devices (which should be the same as the imported medical devices that have already been registered) through a fast-track mode under the 2020 Announcement.
Specifically, according to the 2020 Announcement, the domestic applicants (i.e. foreign-invested enterprises established in China by overseas imported medical devices registrants) can submit certain original documents formerly submitted by the registrants for imported medical device. This means there is no need to undergo the process of preparing and formulating certain documents anew, which will save both time and cost for the domestic applicants.
2. Clarification made by the 2025 Announcement
On the basis of the 2020 Announcement, the 2025 Announcement clarifies the following aspects:
a) Scope of domestic applicants
Article 1 of the 2025 Announcement clarifies that only two kinds of domestic enterprises can apply for the fast-track application mode for the localization of registered imported medical device products:
(1) Enterprises established by the registrants of imported medical device; or
(2) Enterprises under the same actual controller as the registrants of imported medical device. The actual controller should meet the relevant definitions and requirements set forth in the Company Law of the People's Republic of China (“PRC”), which means that an actual controller refers to any person who can exert actual control over the company through any investment relationships, agreements, or other arrangements.
Upon our consultation with the Administrative Reception Center of NMPA (“NMPA Administrative Authority”), “enterprises established by the registrants of the imported medical device” shall refer to those enterprises which are 100% invested by such registrants of imported medical device. Regarding the “enterprises under the same actual controller as the registrants of imported medical device”, the NMPA Administrative Authority replied that currently there is no further detailed internal interpretation on this point.
The above provisions imply that a mere majority participation by an overseas registrant in a Chinese domestic medical device company or a joint venture to be established by the overseas registrant with its Chinese partner where the overseas registration only holds minority shareholding cannot meet the above requirements. However, the 2025 Announcement provides that if the Chinese domestic applicant (invested by an overseas company) has the same actual controller as the overseas registrant, that Chinese domestic applicant can also be deemed as qualified domestic applicants. This means that the foreign company which has the same actual controller as the overseas registrant can set up a subsidiary in China (either through greenfield investment or acquisition) to act as this qualified domestic applicant.
b) Exception for overseas registration invested by a Chinese domestic enterprise
Article 4 (2) of the 2025 Announcement clarifies the exceptional case where the overseas registrant is invested by a Chinese domestic enterprise. In this case, the scope of domestic entities that can apply for the fast-track application mode include:
(1) that Chinese domestic enterprise which has invested in the overseas registrant; or
(2) another Chinese domestic enterprise under the same actual controller as the above-mentioned Chinese investing enterprise.
Similar to point 2. a) above, the NMPA Administrative Authority replied that currently there is no further detailed internal interpretation on the article above-mentioned.
The above provisions make it possible for Chinese enterprises to have shares into the foreign registrants in order to localize the medical devices into China.
c) Scope of the original registration application materials that can be submitted
According to Article 2 of the 2025 Announcement, as to the following documents, the original registration application materials of the imported medical device may be submitted:
– product summary materials;
– non-clinical materials (excluding the checklist of basic principles for safety and performance, product technical requirements, and test reports); and
– clinical evaluation materials.
The scope of documents is expanded compared to those listed for medical device products in the 2020 Announcement, which covers product summary materials, research materials, clinical evaluation materials, and product risk analysis materials.
Also, the 2025 Announcement provides that the product technical requirements and test reports should reflect the product's compliance with applicable mandatory standards.
d) Documents to be submitted to prove the same actual controller
If the domestic applicant shares the same actual controller as the registrant of imported medical device, the domestic applicant shall provide a statement that they are under the same actual controller, as well as the supporting documents. The statement shall cover the information, such as the equity interest relationship between the two parties. The supporting documents shall include the “Enterprise Annual Report” of the domestic applicant where the information of its actual controller is disclosed thereof.
e) Authorization letter
The 2025 Announcement provides that a specific authorization letter issued by the registrant of the imported medical device shall be provided, authorizing the domestic applicant to use the original registration application materials of the imported medical device in both the domestic registration application and production of the products. Such authorization letter shall be notarized by a notary office in the location of the registrant of the imported medical device.
Such requirement of an authorization letter was already included in the appendix of the 2020 Announcement, and the 2025 Announcement further adds the requirement of notarization.
f) Commitment of quality management system
The domestic applicant shall ensure that raw materials and main production processes of the domestic product remain the same as those of the imported medical device. Self-inspection report verifying the compliance of the quality management system for the domestic product with the Good Manufacturing Practice for Medical Devices of the PRC shall be provided, as well as a comparative report on the domestic and overseas quality management systems.
If there are differences in terms of quality management systems, the domestic applicant shall provide detailed explanations, and commit that the relevant differences will not lead to changes in registered items, and the domestic applicant shall take measures for risk management and ensure quality of domestic products.
Compared with the 2020 Announcement, the 2025 Announcement opens up the possibility of differences in terms of quality management systems, under the conditions that the domestic applicant shall ensure quality. However, on a case-by-case basis, whether the commitment and analysis made by the domestic applicant in relation to such differences in terms of quality management are sufficient will be subject to the examination of the authority.
3. Preliminary comments
For those registrants of imported medical devices who are planning to carry out localization in China through the fast-track mode under the 2020 Announcement and the 2025 Announcement, it is especially important to first pay attention to the shareholding structure of the domestic applicant or the controlling effect by ways of agreement or other arrangement over the domestic applicant, in order to meet the criteria set forth in the 2025 Announcement.
The new requirements in terms of shareholding relationship under the 2020 Announcement may also increase more ways of collaborations between Chinese and foreign medical devices companies to realize the localization.
