It is hereby announced that, in order to further strengthen the guiding role of the Guiding Principles for Medical Device Registration Review in the registration application and technical evaluation, the Center for Medical Evaluation has organized the drafting of and now issue a preparation plan of guiding principles for medical device registration review (see the Annex). We hope that manufacturers, trade associations and scientific research institutions related to the medical device industry will pay attention to our specific notifications or solicitation of opinions on the preparation of guiding principles and actively participate in the preparation and revision of the Guiding Principles for Medical Device Registration Review.
Annex: Preparation Plan of Guiding Principles for Medical Device Registration Review 2024 (download)
Center for Medical Device Evaluation (CMDE)
National Medical Products Administration
April 11, 2024
Source: CMDE
Annex: Preparation Plan of Guiding Principles for Medical Device Registration Review 2024 (download)
Center for Medical Device Evaluation (CMDE)
National Medical Products Administration
April 11, 2024
Source: CMDE