Medical equipment class II applications need to prepare a lot of materials, summarized as follows:
Medical equipment business license application form; "business license" copy; legal representative, the person in charge of the enterprise, the quality of the person in charge of the identity card, academic or professional title certificate copy; organization and departmental setup description; scope of operation, business mode description; business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with property rights documents); business facilities, equipment catalog; business facilities, equipment; business facilities, equipment catalog.
In addition, it also includes a basic introduction to the computer information management system and functional description; proof of authorization by the operator; certificate of registration of the product to be operated and attachments; after the information is done, uploaded one by one to the information system corresponds to the * item, there is no correspondent item is uploaded to the other materials uniformly.
Application for medical devices
1, understand the application conditions: enterprises applying for Class II medical device license need to comply with relevant regulations, policies and technical standards, the need to have the appropriate physical assets and business premises and other conditions.
2, finishing the application materials: according to the relevant regulations and standards, prepare the business license, organization code certificate, tax registration certificate and other basic information, while the need to provide product registration certificate, production license, quality management system certification, production of product technical information and other related materials.
3, submit the application materials: the application materials will be organized and submitted to the location of the Drug Administration to apply for the application materials are required to be complete, accurate, compliant, to avoid omissions and wrong items.
4, data review: the Drug Administration to review the application materials, such as the need for enterprises to supplement and modify the problem, until it meets the requirements.