To start the second, the third class of medical device manufacturing enterprise applicants should be to the proposed business location of provinces, autonomous regions, municipalities directly under the Central Government (Food) and Drug Administration to apply, fill out the "Medical Device Manufacturing Enterprises start-up application form" and submit the following information: industrial and commercial administration issued a notice of pre-approval of the enterprise's name or "business license ".
Declaration of information format and requirements
(a) declaration of information is complete, clear, four characters in imitation of Song dynasty, using A4 paper printed on one side or photocopies, and in the above order to form a file submitted
(b) declaration of information should be stamped; such as a single copy of the information more than 2 pages (including 2 pages) need to be stamped with a sewn seal.
(c) "legal representative of the authorized power of attorney" should specify the content of the commission, with a copy of the identity card of the trustee, the power of attorney should be signed by the legal representative and stamped with the official seal.
Declaration of information
The second class of medical equipment business filing form.
Enterprise business license (should be an enterprise, not an individual business), a copy of the organization code certificate.
Enterprise legal representative or person in charge, the person in charge of quality of the identity, education, title certificates.
Enterprise organization and departmental setup description.
Enterprise business address, warehouse address geographic location map, floor plan (indicating the actual area of use), documents proving property rights or lease agreement (with documents proving property rights) copy.
Enterprise business facilities and equipment catalog.
Catalog of business quality management system, work procedures and other documents.
Proof of authorization of the operator.
Other supporting materials. Filing materials should be complete, clear, printed and bound on A4 paper with a catalog, and copies stamped with the official seal and submitted together with the electronic version.