Engaged in the second class of medical equipment business, by the business enterprise to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit its compliance with 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 of the date and stamped with 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 be in line with the following requirements:
(1) "Business Name", "Residence" and business license is the same;
(2) "business premises area, warehouse area" should be consistent with the "Beijing Medical Device Business Supervision and Management Measures Implementation Rules" on the corresponding business scope requirements;
(3) "Mode of operation" within the "wholesale", "retail" or "wholesale and retail" fill in the logic of one of the three options, another "for medical device registrants, filers and business enterprises dedicated to providing transportation, storage services (wholesale or retail)" can be checked separately without choosing the other three modes of operation;
Application materials
1, a copy of the business license and organization code certificate
2, the relevant Person in charge of identification, education or title certificates copies
3, the floor plan of the business premises, real estate documents or lease agreement (with documents proving the ownership of the house) copies
4, business facilities, equipment catalog
5, business quality management system, work procedures and other documents catalog computer information management system basic information and functional description of the operator Proof of authorization