Drugdu.com expert's response:

The direct commissioning of domestic third-party production for imported medical devices is not permitted. This regulation is primarily based on the stringent quality control and regulatory requirements for medical device production. Due to the differences in medical device regulatory systems across different countries and regions, directly commissioning domestic third-party production may pose risks in terms of quality and regulation.

However, the registrant of imported medical devices can produce Class II and Class III medical devices that have already obtained imported medical device registration certificates within China through a foreign-invested enterprise established within the territory. This approach requires meeting certain conditions, such as no changes to the product design and maintaining a consistent quality system, to ensure that there are no significant changes to the safety and effectiveness of the products. Additionally, the original imported registration certificate must be valid; if it has expired or been cancelled, it is not applicable in this scenario.

Furthermore, the National Medical Products Administration (NMPA) has also issued relevant announcements and draft consultation documents to further clarify the specific matters related to the production of imported medical device products within China. For example, the relevant announcements apply to the production of Class II and Class III medical devices that have already obtained imported medical device registration certificates within China by a foreign-invested enterprise established by the registrant of imported medical devices or a foreign-invested enterprise under the same actual controller as the registrant.

In summary, although imported medical devices cannot be directly produced by domestic third parties, the registrant of imported medical devices can establish foreign-invested enterprises and other means to produce within China in compliance with relevant laws, regulations, and regulatory requirements.