National Medical Products Administration, Announcement on Further Clarifying Matters Relevant to the Production of Imported Medical Device Products by Enterprises in Mainland China (Draft for Comments)

Issued: October 29, 2024

Main contents： A foreign-invested enterprise as mentioned in the Announcement may be either an enterprise established by the registrant of an imported medical device or an enterprise under the common control of the same de facto controller with the imported medical device registrant. That is to say, that the Announcement applies to matters relevant to the production in mainland China of a Class II or Class III product with an imported medical device registration certificate by a foreign-invested enterprise established by the imported medical device registrant or by one that is under the common control of the same de facto controller with it.