According to the State Drug Administration (NMPA) in August 2017 promulgated the "Medical Device Classification Catalog" shows that the infrared forehead temperature gun with infrared method of measuring clinical measurement of the patient's body temperature, usually used to measure the temperature of the patient's ear canal, forehead area, should belong to the 07-03-04 body temperature measurement equipment, for Class II medical devices, by the Manufacturer's provincial Food and Drug Administration review and approval.
Production of sales temperature gun need to do what license?
1. Production of forehead temperature gun license required:
① "Medical Device Registration Certificate"
Based on: According to the "Supervision and Administration of Medical Devices", the first class of medical devices for the record management; the second class, the third class of medical devices to implement the management of the registration, the production of forehead temperature gun need to apply for the "Medical Device Registration Certificate";
② "Medical Device Manufacturing
Basis: According to "supervision and management of medical devices (2017 amendment)", engaged in the second, third class medical device production, production enterprises should be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of the food and drug supervision and management department to apply for approval of the issue of medical device production license.
2. Sales temperature gun required license: "medical device business record certificate"
According to the "supervision and management of medical equipment business (2017 amendment)" Chapter 1, Article 4: According to the degree of risk of medical devices, medical device business implementation of classification management. The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices for licensing management.
At the same time, the forehead temperature gun belongs to the body temperature measurement equipment, but involves some related technical requirements, so it also needs to meet the relevant national standards of the test report.
Frontal temperature gun belongs to what business scope can be sold? According to the State Drug Administration (NMPA) issued the "Medical Device Classification Catalog" shows: the forehead temperature gun for Class II medical devices, so the forehead temperature gun sales and production need to obtain the qualification of Class II medical devices. I would like to remind you not to risk your life for a small benefit.