8th November, 2017

According to the “Regulations for the Supervision and Administration of Medical Devices,” "Provisions for Medical Device Registration,” “Provisions for In-vitro Diagnostic Reagent Registration,” and “Provisions for Instructions and Labels of Medical Devices,” when applying for medical device listing in China, the applicant name shall be in Chinese.

CFDA announced the relevant notifications for the medical devices from the foreign manufacturers, including “Naming Principle,” “Administration Procedures and Documentation Requirements,” “The Opening Time of Processing,” and other related matters.

From the published date of this announcement, applicants who already have a listing for medical devices can apply to add the Chinese name of the enterprise though an amendment application. All of the Class I devices shall be changed before December 31, 2018, and the Class II and Class III devices shall be processed before December 31, 2018.


Official press