CFDA Issues New Classification Catalogue for Medical Devices In ChinaTodd Liao
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 Version 2002 New Version Sub-catalogu...
In order to further deepen the reform of the medical device review and approval system, and based on the actual development of the medical device industry and the supervision work, the NMPA organized a dynamic adjustment of the "Medical Device Classification Catalog", selected a batc...
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 ...
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...
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 ...
The Catalogue of medical dev ice classification code and name can be foundhere. How to market your medical devices in China The first important aspect of marketing your medical devices in China is to know how to process, CIRS medical device regulatory team will perform as your local regulatory...
According to the classification catalogue of medical devices issued by China's State Food and Drug Administration (CFDA), in vitro diagnostic equipment belongs to the category of clinical inspection and analysis instruments. About 80% of clinical diagnosis information comes from in vitro diagnosis, and...
Classification Determination In accordance with the Regulations on the Supervision and Administration of Medical Devices: As for a newly-developed medical device that has not yet been listed in the Classification Catalogue for Medical Devices, the applicant may directly apply for NMPA registration in acc...
This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. PROMED products are cleared under FDA 510(k) requirement and are also qualified and ...