Do you know the classification of Chinese medical device NMPA registration?
Considering selling your medical device in China?? If so, you will need to register your medical device with China's regulatory agency, the National Medical Products Administration (NMPA). Below, let's take a look at the classification of China's medical device NMPA registration.
First of all, according to the document No. 739 of the "Regulations on the Supervision and Administration of Medical Devices" issued by the State Drug Administration, the classification management of medical devices is carried out according to the degree of risk.
The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management.
The second category is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness.
The third category is a medical device with high risk that requires special measures to be strictly controlled and managed to ensure its safety and effectiveness.
When you want to determine the classification of a certain product, what methods can we have to determine its classification? Aozida medical device registration introduces several commonly used methods for you.
Method 1: Search in the "Medical Device Classification Catalog 2017 Edition", "In Vitro Diagnostic Reagent Classification Sub-Catalog (2013 Edition)" issued by the Pharmacy and the summary of subsequent batches of classification and definition results;
Method 2: Determine the classification of your own products through the same type of products already on the market;
Method 3: Determine the classification of medical devices according to the "Rules for the Classification of Medical Devices";