Gingival retraction material Triangular needle Skin needle Roller pin The latest medical device classification catalogue is already in effect since the date of the announcement on December 31, 2020. By Jacky Li. ContactCisemaif you would like to learn more....
1. Medical Device Classification Rules (CFDA No. 15) 2. Medical Device Classification Catalogue 3. New edition of the Medical Device Classification Catalogue (No. 104 of 2017) III. Overview of the latest edition of the Medical Device Classification Catalogue - The structure of the new edition ...
CFDA Issues New Classification Catalogue for Medical Devices In ChinaTodd Liao
1. Search the medical device classification catalogue or database China Food and Drug Administration (CFDA) has identified the classifications for approximately 4,000 different generic types of devices and grouped them into 44 medical specific categories. Each of these generic types of devices is assi...
As of 28 March, applications for registration of devices under the “non-ablative radio frequency therapy equipment” category are being accepted by the National Medical Products Administration. This follows China’s recent update of the Medical Devices
To find the classification of your device, you may go directly to the classification catalogue issued by CFDA and search for a part of your device name or keyword and identify your device gradually. It must be pointed out that you will be required to have the Chinese name of your device ...
application method, etc., however, non-sterile liquid and paste dressings will no longer be classified as a class I medical device as seen removed from the new class I medical device catalogue. The NMPA’s proposal of the new medical device classification catalogue (draft) aligns with this cha...
Medical devices are listed in aMedical Device Classification Catalogue, which places the devices into three district categories – depending on the level of the risk they pose to patients and users and this classification will in turn determine the rules that apply (see table below). ...
If you cannot exactly confirm the category of your medical device, applying for the category determination from CFDA is strongly recommended in order to prevent possible confusion caused by improper judgment. d)If you cannot classify your device through classification catalogue and unwilling to refer ...
3.1 Class I Medical Device Catalogue: According to the medical device classification rules, we can find that the following varieties usually be managed as Class I. 3.1.1 Passive medical device which contact human body Medical Dressing, which is used for Skin/Cavity (Mouth) only, and the intend...