Engaged in the second class of medical devices, by the business enterprise to the municipal people's government of the location of the food and drug supervision and management department for the record and submit it to meet the conditions of Article 29 of these regulations to prove the information.
Acceptance conditions
1. The record materials should be complete, clear, require a signature must be signed, stamped with the official seal of the enterprise, using A4 paper printing or copying, according to the order of the materials bound with a directory;
2. Where the record materials need to be submitted to the photocopy of the applicant shall be in the photocopy on the date and Add the official seal of the enterprise;
3. "Class II medical device business filing form" should be signed by the legal representative and stamped with the official seal of the enterprise;
4. "Class II medical device business filing form" fill in the items should be complete and accurate, fill in the content should meet the following requirements:
(1) "Business Name ", "residence" and business license is the same;
(2) "business premises area, storage area" should be consistent with the "Beijing Medical Device Business Supervision and Management Measures Implementing Rules" on the corresponding business scope of the Requirements;
(3) "mode of operation" in the "wholesale", "retail" or "wholesale and retail "Fill in the logic for the three choose one, the other "for medical device registrants, filers and business enterprises dedicated to providing transportation, storage services (wholesale or retail)" can be in the case of not choosing the other three modes of operation to check alone;
Application materials
Application materials
1, business license and organization code certificate copy
2, the relevant person in charge of proof of identity, academic qualifications or titles copy
3, the floor plan of the business premises, real estate documents or lease agreement (with documents proving the ownership of the house) copy
4, business facilities, equipment catalog
5
Procedure
Procedure