In order to make the technical review of medical devices more standardized and scientific and guide medical device registrants / filing entities to prepare product technical requirements, the National Medical Products Administration has organized the revision of the Guidelines for the Preparation of Product Technical Requirements for Medical Devices according to the Regulation on the Supervision and Administration of Medical Devices, the Measures for the Administration of Registration and Filing of Medical Devices, and the Measures for the Administration of Registration and Filing of In-Vitro Diagnostic Reagents, which is hereby released.

It is hereby announced.

Attachment: Guidelines for the Preparation of Product Technical Requirements for Medical Devices

                                National Medical Products Administration

                              February 8, 2022

Attachment to Notice No. 8 [2022] of the National Medical Products Administration.doc

Source: National Medical Products Administration