Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and similar or related items used directly or indirectly in the human body, including required computer software, which are mainly obtained by physical means, e.g., medical imaging devices (ct, electrocardiograms, etc.), active surgical instruments (ultrasonic lithotripsy, orthopedic surgical instruments, etc.), and so on.
The country manages the classification of medical devices according to the level of risk.
The first category is a low-risk, routine management can ensure the safety and effectiveness of medical devices.
The second category is medium-risk medical devices that require strict control to ensure their safety and effectiveness.
The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Medical Devices Classification Directory query
Official query
By searching for "nmpa", enter the State Drug Administration, in the navigation In the navigation bar, select the "Medical Device Query" under Medical Devices, and select the "Medical Devices Classified Catalog" query in all catalogs.
nmpa
Query in the database
Enter the database by searching for "", in the medical device database under the "Medical Device Classified Catalog" can query the content, currently included 3000 More than 3,000 data, data from the State Drug Administration (NMPA) and the China Food and Drug Administration published the standard catalog to complete the database. The database supports precise query, and it can be queried separately by name example, product description and intended use, and queried in accordance with the conditions of "Classification Catalog, Class I Category, Class II Category, Management Category". Between the conditions can be free to combine the query, single query, etc., query is convenient and fast. All standards provide full-text search, download.
Listed in the conditions of screening in the "management category" select "Ⅲ" click on the search can query to all "Ⅲ" medical device related results.
In the results include product name, classification, primary category, secondary category, product description, intended use, management category, and the search results can be exported.
Medical Device Classification Catalog
The above is the way to query the medical device classification catalog, these two are the more common query, compared to the official query, the database query is more convenient, not only can directly query the classification catalog of the medical device, but also query the standard catalog of the medical device, the Chinese device review, the listing of the device data, the global medical devices, listing data, market data, research and development data. It is more convenient to search not only the catalog of medical devices, but also the standard catalog of medical devices, China device review, device listing data, global medical device listing data, market data, R&D data, clinical trial data and so on.
Medical Devices Classification Catalog