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 the 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 degree 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 high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Medical Equipment Classification Directory inquiry
Official inquiry
Search "nmpa", enter the State Drug Administration, in the navigation bar, select the medical device under the "Medical Device Query", in all the catalogs, select "Medical Device Classification Catalog" query.
Medical Devices Classified Catalog
Query in the database
Through the search, enter the database, in the medical device database under the "Medical Devices Classified Catalog" can be queried, the current collection of more than 3,000 pieces of data! The database supports precise query, can be a sample name, product description and intended use of separate query, and in accordance with the "classification catalog, the first category, the second category, management category" and other conditions for query. 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 as in the conditions of filtering in the "management category" select "Ⅲ" click on the search can query all the "Ⅲ" medical equipment 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