The first class of medical devices is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling patches, etc., its products and production activities by the municipal level of the location of the district Food and Drug Administration to implement record management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector.
2, Class II - Municipal Food and Drug Administration for the record of medical devices
The second class of medical devices is a medium risk, need to strictly control the management of medical devices to ensure their safety and effectiveness, such as our daily life in the common band-aid, condoms, thermometers, sphygmomanometers, oxygen concentrators, nebulizers, etc., its products and production activities by the municipal food and drug regulatory departments. Its products and production activities are licensed by the provincial food and drug regulatory authorities, and are issued with "Medical Device Registration Certificate" and "Medical Device Production License" respectively. Business activities by the municipal food and drug regulatory departments to implement record management;
3, Class III - State Drug Administration for medical device license
Class III medical devices is a higher risk, the need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices, such as common The infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration, etc., its products and production and management activities by the State Administration, provincial food and drug regulatory departments and municipal food and drug regulatory departments to implement the licensing and management, respectively, issued by the "Medical Device Registration Certificate", "Medical Device Manufacturing License," "Medical Device License", "Medical Device License".
Enterprises operating medical device products need to apply to the local Food and Drug Administration, "Medical Device Business License" a medical device company registration required materials
1, business name and scope of business, the registered capital and shareholders' capital contribution ratio, shareholders and other proof of identity;
2, medical device product registration certificate, manufacturer's license, Business license and authorization;
3, quality management documents, etc.;
4, more than three medical or related professional certificates, identification and resume;
Two, medical device company registration process
1, to the Trade and Industry Bureau to apply for the "pre-approval of the enterprise name notification";
2, the opening of a capital verification account, the shareholders to contribute. Accounting firm issued a capital verification report;
3, for business license
4, engraved seal;
5, for organization code certificate;
6, for tax registration certificate;
7, the local Food and Drug Administration website to submit the online application materials;
8, the online material review and approval of the Pharmacy and Drug Administration Appointment and inspect the business site;
9, submit written application materials, audit and approval of the issuance of the "Medical Device Business License";
Three, medical device company tax incentives
1, business tax: the fiscal rebate of 35% of the actual amount of tax paid.
2, value-added tax: the fiscal return of 7% of the actual tax amount.
3. Corporate income tax: 12 percent of the actual tax paid.
Every quarter, the Finance Bureau transfers the enterprise support money directly into the company's account.
Medical equipment is engaged in the medical industry must have the documents if the information should be submitted can be properly prepared to register very quickly I hope you register smoothly!