Application form for medical device business enterprise license; Certificate of pre-approval of enterprise name issued by the administrative department for industry and commerce; A copy of the identity card, education or professional title certificate and resume of the quality management personnel of the proposed enterprise; The organization and functions of the proposed enterprise; A copy of the geographical location map, floor plan (indicating the area) of the registered address and warehouse address of the proposed enterprise, and the house property certificate (or lease agreement); Product quality management system documents and storage facilities and equipment catalogue of the proposed enterprise; Business scope of the enterprise to be established.
legal ground
First, the information needed to apply for a medical device license;
1, original and photocopy of company license
2. Official seal
3. Copies of the office and warehouse.
4. Personnel (mainly quality managers and competent inspectors)
Among them, quality manager: three years' college graduation is required.
Inspector in charge: Bachelor degree is required for at least three years, majoring in inspection science.
Two, for medical device license requires the following process:
1, the business scope should be "selling medical devices"
2. Submit an online application for medical device materials.
3, drug supervision and management window to submit three materials (with the original), waiting for the verification notice.
4. Obtain a medical device license (if there is Category II, submit the materials, which will be the filing form for the whole world).
Three. Validity period/treatment period
, 1, the third kind of validity: 5 years.
2. Class II filing form: no validity period.
3. Acceptance time: 5 working days after the materials are accepted.
The above is the data flow and issuing time required for the medical device license.
The company also handles district clinics, Chinese medicine clinics, beauty massage hygiene licenses, second-and third-class filing and approval of medical devices, medical device product registration certificates, and medical through-train services. When you come to us, you will eventually find a professional to serve you.
Beijing Daxing Medical Device Company registered to provide office warehouse.
How to handle the third-class certificate of medical devices in Daxing, Beijing
Address and personnel handling Class II and Class III medical devices in Daxing, Beijing.
There is no need to verify the formal filing of Class II medical devices in Beijing Daxing Tongzhou Huairou.
Acting medical device business license
Two or three kinds of medical device business licensing agents.
To sell the third kind of medical devices, it is necessary to obtain the permission of the corresponding department, that is, the Medical Device Business License. To meet the requirements of three types of medical devices, you need a quality administrator, computer management software related to medical devices, verifiable warehouses and offices, and a series of materials. If you don't know where to buy software because of insufficient staff or no address during the processing, please call for advice.