Does the intelligent electronic thermometer need a medical device production license?

When necessary, according to Article 27 of the Measures for the Supervision and Administration of Medical Device Production, the entrusted party of medical device production shall be a production enterprise that has obtained the License for Medical Device Production Enterprise or registered a first-class medical device production enterprise in accordance with the provisions of these Measures, and meet the following conditions:

(1) The production scope includes medical devices commissioned for production;

(2) The production conditions, testing capacity and quality management system shall be suitable for the medical devices commissioned for production;

(3) Sterile disposable medical devices and other medical devices as otherwise stipulated by the US Food and Drug Administration, in addition to the above provisions, the trustee must also have a medical device registration certificate covering the products entrusted for production.

Since thermometers belong to Class 2 medical devices, it is necessary to obtain a production license.