One, forehead temperature gun belongs to the class of medical devices?
Answer: According to the "Medical Device Classification Catalog", the forehead temperature gun belongs to the "6820 General Diagnostic Instruments" class of temperature measurement equipment, the management category is: Class II medical devices.
What are the qualifications required for the production of forehead temperature gun?
Two, the production of sales of temperature guns need to do what licenses?
Answer:
1. The production of the amount of warm 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 the amount of warm gun need to apply for the "Medical Device Registration Certificate";
Production of sales What are the qualification conditions needed for the production of temperature guns?
What are the qualifications required for the production of sales temperature gun?
② "Medical Device Manufacturing License"
Basis: According to the "supervision and management of medical devices (2017 Amendment)", engaged in the production of second and third class medical devices, the manufacturer should apply to the food and drug supervision and management department of the people's government of the local province, autonomous region and municipality directly under the central government, and the approval of the issue of medical device manufacturing license.