Sales of medical devices need to qualify:
1, do medical devices need to apply for relevant documents, the sale of medical devices need to apply for sales-related qualifications, such as Class II device sales filing vouchers, the production of medical devices need to apply for a production license or production filing vouchers;
2, engaged in the production of Class I medical devices, by the manufacturer to the location of the district of the Municipal people's government food and drug supervision and management department for the record and submit their proof of compliance with the prescribed conditions;
3, engaged in the production of Class II, Class III medical devices, the manufacturer should be located in the provinces, autonomous regions, municipalities directly under the Central People's Government food and drug supervision and management department to apply for a production license and submit their proof of compliance with the prescribed conditions and the production of medical devices registration certificate;
4, engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record and submit their compliance with the prescribed conditions of the information;
5, engaged in the operation of Class III medical devices, the business enterprise shall be located in the municipal people's government food and drug supervision and management department to apply for a license to operate and submit its Meet the prescribed conditions of the supporting information.
Legal basis: "Supervision and Management of Medical Devices Regulations" pat Bi Lao Article 21
Registered Class II, Class III medical assault and ascending device products, its design, raw materials, production processes, scope of application, methods of use, etc. have undergone substantial changes that are likely to affect the safety of the medical device, effective, the registrant shall apply to the The original registration department to apply for a change in registration procedures; other changes, should be in accordance with the provisions of the State Council drug supervision and management department for the record or report.
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