What are the materials needed for medical device license additions?

Call to your local drug supervision bureau to consult it. It should be accepted by the office, or directly to the medical equipment, you can also log on to the local drug supervision bureau netma first look.

I searched for the Beijing Municipal, lending you reference:

Enterprises log on to the Beijing Drug Administration business service platform for online reporting, enterprises according to the provisions of the scope of acceptance, the following application materials need to be submitted (if the content of the change if the content of the change involves immediate changes should be provided with the content of the change of the immediate change of the required materials):

1. "Medical Device Business Enterprise License 〉 Project Change Application Form ", (please go to the Beijing Municipal Drug Administration website to fill out and print);

2. "Medical Device Business License" copy of the original original, copy of the original and copy;

3. Industry and Commerce "Business License" copy of the original and copy;

4. (1) change of registered address (refers to the business address of the enterprise registration), Warehouse address, should also be submitted:

① registered address, warehouse address of the geographic location map, floor plan (indicating the area), proof of property rights (or lease agreement) original and copy; change the warehouse address, and submit the storage equipment, facilities directory;

Enterprises to take a centralized way to store the products, you need to submit the corporate "Business License," "Medical Device Business Enterprise License" and its corporate legal entity centralized warehouse instructions (can no longer be submitted to the warehouse of the proof of ownership or lease agreement and the warehouse address of the buried location map and floor plan);

② intends to set up additional warehouses across the province, it is also necessary to submit additional warehouses to be set up for the acceptance of quality personnel ID card, education or title copies of proof and storage conditions of the warehouse instructions.

(2) change the scope of business, should also be submitted:

① a copy of the registration certificate of the product to be operated;

② storage equipment, facilities directory;

③ change the scope of business at the same time need to be in accordance with the "Beijing Medical Device Business Inspection and Acceptance Standards," "In Vitro Diagnostic Reagent Business (Wholesale) Acceptance Standards," the increase in the size of the warehouse. Need to submit proof of property rights of the warehouse or lease agreement and warehouse address geographic location map, floor plan (indicating the area);

④ change the scope of business at the same time need to "Beijing medical equipment business inspection and acceptance criteria", "in vitro diagnostic reagents business enterprises (wholesale) acceptance criteria" to increase the quality of management personnel, the need to submit quality management personnel's proof of identity, proof of academic qualifications or professional title certificate Original and copy and personal resume, increase the operation of in vitro diagnostic reagents should be submitted at the same time the licensed pharmacist, supervisor of the inspector's qualification certificate and appointment letter original and copy. Enterprises should also submit changes in personnel appointment and removal decisions or board of directors' resolutions;

⑤ increase the operation of in vitro diagnostic reagents should also be submitted to the enterprise: a. Legal representative of the enterprise, the person in charge of the enterprise's original certificate of academic qualifications and photocopies and biographical information; b. Business premises, equipment, storage facilities and the surrounding health environment and other circumstances;

5. Self-assurance statement of the authenticity of the materials declared, including the declaration of the material if it is false, the declaration of authenticity of the material, including the declaration of authenticity of the material. Including the enterprise to the material to make a commitment to bear legal responsibility if false;

6. Where the application for the enterprise declaration materials, the processing staff is not the legal representative or person in charge of himself, the enterprise should be submitted to the "power of attorney" 2 copies.