Storage facilities, equipment, including ground beat (moisture-proof boards), thermometers, hygrometers, firefighting equipment, etc., these are the basic, and the rest according to the operation of different medical equipment will have special requirements, such as storage in the basement need dehumidifiers and so on.
Self-inspection report online there are many models, so the next format regulation with good.
Enterprise organization and functions also have a lot of models, if the company is not very big is not very concerned, there is a basic department can be, such as the Ministry of Finance, Logistics Department, the Ministry of Markets, Logistics Department, including warehouses, quality control, the Ministry of Markets, including the development of after-sales service. As for the function, it is also recommended that you go online and search one by one, and then take out a good out of a business organization function.
"Medical device business enterprise license" declaration materials?
(a) the declaration of materials directory
(b) the proposed enterprise's legal representative signed the application; branch applying for the application of "medical device business enterprise license", should provide the application issued by the parent legal entity, and stamped with the official seal.
(iii) Application Form for Medical Device Business Enterprise License.
(d) the business administration department issued by the enterprise name pre-approval documents or stamped with the official seal of the enterprise "business license" copy of the original and duplicate.
(E) the proposed enterprise legal representative and the person in charge of the enterprise, quality management personnel without "supervision and management of medical devices regulations" Article 38, Article 39 of the written description of the situation (signed by the legal representative of the enterprise and the person in charge of the enterprise, quality management).
(F) the proposed enterprise legal person, the person in charge of the enterprise, quality management, quality management organization responsible person and the person in charge of the after-sales service organization's personal resume, identity card, academic qualifications or certificates of title copies and not part-time job certificate.
(vii) the proposed enterprise organization and function (including organization and function of the block diagram, enterprise quality management and after-sales service personnel table).
(viii) the proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the specific location, functional layout, three-color five-zone setup, area, etc.), proof of property rights (or purchase contract) and a copy of the lease agreement.
(ix) the proposed enterprise warehousing facilities and equipment and the surrounding environment description; corneal contact lenses, hearing aids business enterprises to fill out the "corneal contact lenses / hearing aids business dispensing premises and facilities and equipment table.
(J) proposed enterprise product quality management system document catalog.
(k) the proposed business scope of the enterprise and "to operate the medical device product details.
(xii) to configure the computer management information system.
(xiii) enterprise quality management personnel on duty to ensure that the statement.
(xiv) declaration of authenticity guarantee statement.
(xv) the proposed enterprise's legal representative signed for the "Medical Device Business Enterprise License" related procedures for the authorization of personnel; branch applying for the "Medical Device Business Enterprise License", you need to submit the higher legal entity company's letter of authorization.
(xvi) City Food and Drug Administration request for instructions and on-site acceptance of business enterprises on-site acceptance criteria score sheet, on-site review report.
(xvii) Municipal Food and Drug Administration that need to be submitted to the other supporting materials (retained by the City Council).
Note: 1, the enterprise to provide copies of various documents should be accepted by the Municipal Bureau of the reviewer to indicate consistency with the original, and signed and dated.
2, the content of the declaration should be filled in true, accurate, complete, and shall not be altered.
3, all the declaration information should be A4 type paper in order to bind the report.