Interpretation of the announcement on matters related to the production of imported medical device products by enterprises in China

The Notice of the State Drug Administration on Matters Related to the Production of Imported Medical Device Products in Enterprises in China (No. 104 of 2020) was issued on September 23, 2020 and shall take effect as of the date of publication (hereinafter referred to as the Notice). The background, main principles and key issues of the Announcement are explained as follows: 1, the background of the AnnouncementIn recent years, the industry has made production of imported medical device products in Enterprises in China, optimized the relevant registration and declaration information, and avoided registration. Since 2019, the State Drug Administration has drafted this announcement after in-depth investigation and full listening to the opinions of all parties, in order to implement the requirements of the CPC Central Committee and the State Council to deepen the reform of "discharge" and optimize the business environment, and to deepen the reform of the medical device review and approval system.Second, the main principlesThe Bulletin refers to the relevant international requirements, combined with China's medical device registration, supervision, clinical use and other practical conditions, based on the principle of scientific supervision of medical devices, in the product design does not change, the quality system remains basically consistent, product safety effectiveness has not changed significantly, through the recognition of some registered imported medical devices of the original submitted registration declaration data, so as to optimize the corresponding examination of information requirements, to avoid the duplication of information.The Proclamation also clarifies the principle of consistency between domestic enterprises and foreign enterprises, and applies equally to domestic enterprises investing in overseas enterprises and producing in domestic enterprises.3. Key Issues Note(1) Limitation of the scope of applicationThe scope of application of the Notice clearly states that "the registrar of imported medical devices shall, through the foreign-invested enterprises established in China, produce the second and third categories of imported medical device registration certificate products in China, and shall apply to the relevant matters." This is because the relevant registration declaration information is optimized on the premise that the relevant product design does not change, the quality system and overseas equivalent and traceability, the close relationship between domestic and foreign registration subjects is an important basis to ensure the above premise.(2) Whether the circumstances of the Proclamation apply to the pilot work of the medical device registrar system the purpose of the Announcement is to optimize the registration and declaration information within the framework of existing regulations for the production of imported medical device products in domestic enterprises. Products shall be produced by foreign-invested enterprises established by the registrar of imported medical devices in China and shall not be commissioned within the scope of the pilot work of the medical device registrar system.(3) The corresponding requirements for the validity of the original registration certificateThe Notice applies to products within the validity period of the medical device registration certificate, and the original import registration certificate has been invalidated or cancelled does not apply to this announcement.(4) The relationship between the newly obtained registration certificate and the original imported medical device registration certificate The Notice clearly states that if the registration application is submitted and approved in accordance with the requirements of the Bulletin, the medical device registration number of the original imported product that has been approved for registration shall be included in the note column of the registration certificate, so as to facilitate the identification and traceability of the registration certificate of the relevant transferred production products by the drug supervision and administration departments at all levels. The domestic medical device registration certificate and the original imported medical device registration certificate are independent of each other and are managed separately.The publication of the Bulletin conforms to the requirements of "discharge suit" and the principle of scientific supervision of medical devices, which is conducive to saving resources, improving the efficiency of review and approval, promoting the healthy and rapid development of the entire medical device industry, and better meeting the health needs of the people.

the State Drug Administration
2020-09-25