1, medical device registration certificate: imported medical devices need to apply for a medical device registration certificate, after obtaining the registration certificate can be sold and used in China. Registration certificate is the access to imported medical devices to prove that the device has been approved by the China Drug Administration, to be able to legally sell and use in China;
2, imported medical devices for the record: after obtaining the registration certificate of medical devices, but also need to be in the China Drug Administration for the import of medical devices for the record, for the record can only be entered into the Chinese territory for sale and use;
3, proof of origin: imported medical devices need to provide proof of origin, prove that the origin of the device meets the requirements of the China Drug Administration;
4, proof of manufacturer: imported medical devices need to provide proof of manufacturer, prove that the device manufacturer meets the requirements of the China Drug Administration, with the qualification of production of the appropriate medical device;
5, inspection Report: Imported medical devices need to provide inspection reports in line with the requirements of the China Drug Administration, to prove that the quality and safety of the device in line with the requirements of the China Drug Administration.
The process of importing medical devices is usually as follows:
1, registration application: the importer needs to register the medical device in the State Drug Administration (NMPA), submit the relevant information, including product specifications, quality standards, production licenses and so on;
2, application for approval: the NMPA on the importer's submission of the application for registration for approval, to review product quality
3, import license: NMPA based on the approval of the conclusion to the importer to issue a license to import medical devices, permission to import the relevant products;
4, customs record: importers are required to declare to the Customs and Excise Department imported medical equipment information, including product name, model, quantity, manufacturer, place of origin, etc., and to submit the relevant supporting documents;
4, customs record: importers are required to declare to the Customs and Excise Department imported medical equipment, including product name, model, quantity, manufacturer, place of origin, etc., and submit Relevant documents;
5. Customs inspection: Customs inspection of imported medical devices to ensure that it meets the relevant national standards and regulations;
6. Payment of taxes and fees: Importers are required to pay the relevant taxes and fees to the Customs and Excise Department, including tariffs, value-added tax, etc.
7. Receiving and inspection: Importers receive medical devices to ensure that the content of the order with the acceptance, no damage and other issues;
8. No damage and other problems;
8, market supervision: the importer needs to strengthen market supervision in the product sales process to ensure product quality and safety.
In summary, the qualifications required for different types of medical devices for different purposes may vary, and the specific requirements are subject to the regulations of the China Drug Administration. In addition, imported medical devices need to go through customs inspection and release procedures before they can be sold and used in China.
Legal basis:
Article 5 of the Law of the People's Republic of China on the Inspection of Import and Export Commodities
Import and export commodities listed in the catalog shall be inspected by the commodity inspection agency.
The imported commodities specified in the preceding paragraph are not allowed to sell or use without inspection; the exported commodities specified in the preceding paragraph are not allowed to be exported without passing the inspection.
Article 11
The provisions of this Law must be inspected by the commodity inspection agency of the consignee of imported goods or their agents, shall be declared to the place of customs clearance of the commodity inspection agency.
Article 12
The consignee or his agent of imported goods which must be inspected by the commodity inspection agency under this Law shall accept the inspection of imported goods by the commodity inspection agency at the place and within the period prescribed by the commodity inspection agency. Commodity inspection agency shall be unified in the state commodity inspection departments within the period specified in the inspection is completed, and issued a certificate of inspection.