What materials do I need to apply for a medical device company? Including the first class, the second class and the third class medical devices.

The state implements classified management of medical devices. According to the principle of ensuring safety and effectiveness, medical devices are divided into Class I, Class II and Class III.

The first category, the second category and the third category products are all included, and specific products need to be pointed out. Otherwise, the scope is still too wide. Otherwise, it becomes "all kinds of medical devices".

Application materials for license of medical device business enterprise

Materials required:

(1) Registration Form of Application Materials for Medical Device Business Enterprise License;

(2) Application Form for Shanghai Medical Device Business Enterprise License;

(3) A certificate of pre-approval of enterprise name or a copy of business license issued by the administrative department for industry and commerce;

(4) A copy of the ID card, education or professional title certificate and resume of the person in charge of quality management of the proposed enterprise (graduated from clinical medicine or related medicine (Chinese medicine is not accepted). Require this person to have a college degree or above);

(5) A copy of the ID card, educational background or professional title certificate of the quality inspector of the proposed enterprise; Graduated from clinical medicine or related medicine (not accepting Chinese medicine). This person is required to have a college degree or above. ) Inspectors have technical secondary school education or above, majoring in medicine (education does not include pharmacy).

(six) the organization and functions of the enterprise to be established or the functions of full-time quality management personnel;

(7) A copy of the registered address of the proposed enterprise, the geographical location map of the warehouse address, the floor plan (indicating the area), the property right certificate of the house or the lease agreement (with the property right certificate of the leased house attached);

(eight) the product quality management system documents and the catalogue of storage facilities and equipment of the enterprise to be established;

(9) The business scope of the proposed enterprise shall be determined according to the management category and category code specified in the Catalogue of Medical Devices;

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