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2024-01-25
Function and Safety Evaluation
The Center boasts the facilities necessary for raising large experimental animals and primates. It is equipped with state-of-the-art global equipment and led by a professional research team, headed by ...
2024-01-24
The latest guidelines for Ophthalmic Ultrasonography and glass-cutting equipment, open for public consultation
IntroductionIn accordance with the requirements outlined in the 2023 National Medical Device Registration Review Guidelines, the Device Center has undertaken the revision of the "Guidelines for Te...
2024-01-10
Catalogue of Guiding Principles for Medical Device Registration Review released by the Equipment Review Center (as of the end of 2023)
In recent years, China has made significant strides in constructing its guiding principle system for medical devices. Both the quality and quantity of these guiding principles have notably improved, wh...
2023-11-14
The Medical Device Standards Management Center has issued a public call for feedback on the Draft Guiding Principles for the Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment.
Medical Device Standards Management Center of the National Medical Products Administration and in collaboration with the Zhejiang Medical Device Inspection and Research Institute, the Draft Guiding Pri...
2023-09-20
Concise guide for medical device registration
Novice medical device registration practitioners are often at their wits end in front of specific challenges. These challenges include searching for regulatory and technical evaluation criteria, execut...
2023-09-09
The National Medical Products Administration has released the latest 45 industry standards for medical devices
The National Medical Products Administration has approved and published 45 medical device industry standards, including YY 0304-2023 "Plasma sprayed hydroxyapatite coated titanium based dental imp...
2023-09-05
Call for feedback on two standards for medical device industry
Today, in line with the work plan of the National Medical Device Clinical Evaluation Standardization Technology Centralized Unit for standard formulation in 2023, the unit has finalized two industry st...
2023-08-24
Inventory of guidelines released in the first half of 2023
In the first half of 2023, the Medical Device Registration Review Center undertook significant efforts to enhance the oversight and direction of medical device product registration processes. A compreh...
2023-08-18
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices
To advance the ongoing reform of the medical device evaluation and approval system, the National Medical Products Administration has decided to amend certain sections of the Classification Catalogue of...