The announcement of related matters on imported medical device manufacturing in China was published in 23rd September, 2020(hereinafter referred to as ‘The announcement’). This article will introduce the background, main principles and the analysis of the major problems around this announcement.
The voice of the industry of imported medical device manufacturing in China, about improve the registration dossiers and avoid to declare of repeat registration requests has increased in recent years. Therefore, since 2019 the NMPA has collected the opinions and drafted the announcement, in order to simplify the process of approval and review system.
2. The main principles
The announcement was made in considered of international requirements, combined with domestic medical device registration, supervision, and clinical trial conditions. Based on the principles of no changes on product design, product quality system, no distinct product safety and effectiveness changes that the imported medical devices which already in catalog is approved to avoid repeating information submitted.
The announcement also clarifies that the industry of domestic enterprise invested overseas also applicable to this announcement.
3. Explanations on major aspect
a. the scope of limitation
The scope of application of the Announcement clearly states that “this announcement is applicable to matters related to the production of imported medical device registration certificate products of Class II and Class III in China by the registrant of imported medical device through the foreign-invested enterprises established in China” This is because, to optimize the relevant registration declaration materials, the premise is that the relevant product design does not change , the quality system has the same gender and traceability with the overseas, and the close connection between the domestic and foreign registration subjects is an important basis to ensure the above premise.
b. whether this announcement adopt to the medical device registrant system
The aim of the announcement is to optimize the relevant registration declaration materials for imported medical device which manufactured their product in China. the medical devices should be produced by foreign-invested enterprises established in China by the registrant of imported medical devices. They are not within the scope of the medical device registrant system and cannot be commissioned.
c. The requirements for the validity period of the original registration license
The announcement is applicable to products whose medical device registration license is within the validity period. The original import registration license has expired or cancelled is not applicable to the announcement.
d. The relationship between the newly obtained registration license and the original imported medical device registration license
The announcement clarifies that if a registration application is submitted and approved in accordance with the requirements of the announcement, the remarks column of the registration license should include the medical device registration number of the original imported medical device that has been approved for registration, so that the NMPA at all levels can check the relevant materials, the domestic medical device registration license and the original imported medical device registration license are independent of each other and managed separately.