1. Class I: medical devices whose safety and effectiveness can be guaranteed through daily management;
2. Category II: Medical devices whose safety and effectiveness should be controlled;
3. Three kinds: implanted into human body; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.
You don't need to apply for permission to operate Class I, and you don't need to file Class II medical devices to operate Class II; Those who engage in category III need to apply for a license to engage in category III medical devices.
Then how to check the medical device business license?
At present, there are many ways to inquire about the business license of medical devices. For example, the official (NMPA) National Medical Products Administration is often used for inquiry. At present, you can also query some medical device databases. Here is a brief introduction to the inquiry method of medical device business license.
Official inquiry method: First, search "NMPA" State Administration of Medical Supplies, go to the homepage of official website, select "Medical Devices" in the navigation bar and click Enter, and select the medical device business enterprise (license), which can be inquired by the license number and enterprise name.
Business certificate
Compared with the official, it is recommended to query the database. The data comes from official data, which is cleaned and sorted to reflect the real data. All the data are well documented, authentic and reliable, and it is more convenient to query. It is an important tool to master the information of domestic enterprises.
Keyword search can be conducted by enterprise name, license/record number and business scope, date filtering can be conducted by issuing/filing date and validity period, condition filtering can be conducted by province, business model and enterprise type, and medical device business enterprises (licenses) can be quickly queried by intelligent search methods such as fuzzy search, precise search, combined search and advanced search (and, or, or, not).
For example, if you search for "Ankang Pharmaceutical" in the enterprise name and select "Sichuan" in the condition screening, you can find all the business licenses of Ankang Pharmaceutical in Sichuan, as well as information such as business premises and business scope.
Inquiring method of medical device business license
Click "Enterprise Name" to enter the details page, and learn all the information of the medical device business license, including (enterprise name, license/record number, legal representative, person in charge of the enterprise, residence, warehouse address, business place, business scope, business mode, issuing/filing department, issuing/filing date, validity period, province and enterprise type) and other data.
Medical device business license
The above is the inquiry method of medical device business license. Compared with official data, data query is more convenient and data dimension is more urgent.