Requirements:
1. The second class of medical equipment business filing form; (the filing form needs to be signed by the legal person)
2. A copy of the business license; (Note: the business scope of operation should have "the second class of medical equipment business")
The first filing of the second class of medical equipment business is required for the first time. p>3. Legal representative of the enterprise, the person in charge of the enterprise, the quality of the person in charge of the identity card (necessary), a copy of the certificate of education or title certificate (choose one).
4. organizational structure and departmental setup description; (departmental setup description is to illustrate the main responsibilities of each position)
5. business premises, warehouse address location map, floor plan (drawings written on the actual area of use), a copy of the lease contract and documents proving ownership of the house (business premises, warehouse address proof of ownership of the house: real estate license, filing certificates, proof of use of the site) One of the three can be)
6. business facilities and equipment directory; (refers to the business premises and warehouse facilities and equipment)
7. business quality management system directory
8. work program directory;
9. original power of attorney and a copy of the agent's identity card; (the power of attorney needs to be signed by the legal person)
10. record material Authenticity of the self-assurance statement (legal person needs to sign)
11. Treasury address is entrusted to a third-party company storage, distribution, you need to submit a copy of the third-party company's two types of filing certificates, a copy of the business license, and a copy of the agreement signed by both parties to the contract. (Not entrusted to a third-party company storage, distribution is not required to provide)
12. Declaration of material catalog (submitted by the material 123... (listed)
Materials each page should be stamped, and then color scanned into a PDF format, the file is less than 20M, placed on a USB flash drive)
Key note
Class II medical device business scope: Class II medical devices (excluding in vitro diagnostic reagents), Class II medical devices in vitro diagnostic reagents, Class II medical devices containing in vitro diagnostic reagents, the above three options One. Scope of business: without in vitro diagnostic reagents: the quality of the person in charge of medical devices should have a medical device-related professions (medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, testing, computers, law, management and so on) above the junior college level. Containing in vitro diagnostic reagents or in vitro diagnostic reagents: quality management personnel, there should be a supervisor of the inspector, or with a college degree or above in testing-related disciplines and engaged in testing-related work for more than 3 years of work experience. Quality management personnel can not be part-time other positions. Engaged in in vitro diagnostic reagents acceptance and after-sales service personnel, should have a secondary school education in laboratory science or related disciplines, or with a junior or above the professional and technical title of the inspector. Operation of implantable and interventional medical devices, should be equipped with a college degree or above in medicine-related fields, and after the production company or supplier training personnel. The operation of hearing aids and other medical devices with special requirements, should be equipped with relevant professional or dispensing professional qualifications. Third-party logistics and distribution enterprises1, to have 3,000 square meters of warehouses, 2, with the commissioning party to implement real-time electronic data exchange and the realization of the whole process of product management can be traced back to the traceability of the management of computer information platforms and technical means; 3, with the acceptance of food and drug supervision and management department of the electronic monitoring of the data interface. 4, the organizational structure should be the quality of the management, receipt and inspection, storage, checking, and then the management of the product, and the management of the product. , warehousing, storage, inspection, warehousing, review, transportation, computers and facilities and equipment maintenance and other positions.
Storage address: to be entrusted to the medical device third-party logistics materials to be submitted:
Guangzhou: the other party's business license, Class II filing voucher, and the two sides signed a storage and distribution contract.
Outside Guangzhou: the other side of the business license, the second class of the record certificate and the two sides signed a storage and distribution contract, warehouse facilities and equipment directory, address location map, floor plan.