The production of thermometers under license plate need medical device production license?

Need, according to the "supervision and management of the production of medical devices" Article 27 of the commissioned production of medical devices entrusted to the production of the trustee shall be to obtain the "Medical Device Manufacturer License" or in accordance with the provisions of this approach to the first class of medical equipment manufacturers informed the registration of the production enterprise, and in line with the following conditions:

(a) the scope of its production should cover the commissioned production of medical devices;

(ii) the production conditions, testing capabilities, quality management system should be compatible with the entrusted production of medical devices;

(iii) single-use sterile medical devices and the State Food and Drug Administration otherwise provided for other medical devices, in addition to the above provisions should be met, the entrusted party must have a certificate of registration of medical devices covering the entrusted production of products.

Since thermometers are class 2 medical devices, you must obtain a manufacturing license