To apply for a business license, a series of documents need to be submitted, including the application for establishment registration, the certificate of the designated representative or co-entrusting person of all shareholders, the articles of association, the main qualification certificate of the shareholder or the identity certificate of the natural person, the name and domicile of the director, supervisor and manager, the certificate of appointment, election or employment, the appointment document and identity certificate of the legal representative, the notice of pre-approval of the enterprise name and the certificate of the company's domicile. For the record of Class II medical device operation, it is necessary to submit a copy of the business license and the first certificate of the organization, the identity certificate of the legal representative, the person in charge of the enterprise, the person in charge of quality, the copy of the certificate of education or professional title, the description of the organization and department, the business scope, the description of the business mode, the geographical location map of the business premises and the address of the warehouse, the floor plan, the copy of the house property right certificate or the lease agreement (with the house property right certificate) and other materials.
In addition, according to the Measures for the Supervision and Administration of Medical Device Operation, the medical device business implements classified management. The operation of Class I medical devices does not require licensing and filing, the operation of Class II medical devices is subject to record management, and the operation of Class III medical devices is subject to license management. At the same time, it is necessary to have corresponding conditions for engaging in the operation of medical devices, including having a quality management organization or quality management personnel suitable for the business scope and business scale, having a business and storage site suitable for the business scope and business scale, and having storage conditions suitable for the business scope and business scale.
When going through the filing procedures for the operation of Class II medical devices, it is necessary to provide business facilities, equipment catalogs, business quality management systems, working procedures and other document catalogs. In addition, proof of authorization from the handler is also required. These procedures are carried out to ensure the safety and effectiveness of medical devices and to protect the health and safety of the public.