The structural characteristics of medical devices are divided into: active medical devices and passive medical devices.
(ii) Forms of use of medical devices
Medical devices are categorized into certain forms of use according to different intended purposes. Among them:
1, the use of passive devices in the form of: drug delivery and preservation devices; change blood, body fluids devices; medical dressings; surgical instruments; reuse surgical instruments; disposable sterile devices; implantable devices; contraception and family planning devices; disinfection and cleaning devices; nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary devices, etc..
2, the use of active devices in the form of: energy therapy devices; diagnostic and monitoring devices; delivery of body fluids devices; ionizing radiation devices; laboratory instruments and equipment, medical disinfection equipment; other active devices or active auxiliary equipment.
Import operation process:
1, the signing of the import contract, the foreign supplier shipments;
2, shipping to the domestic terminal or air transport to the airport; to the port of the shipping company (airlines) to send a notice of arrival;
3, with the notice of arrival to the shipping company to change the bill;
4, according to the regulatory conditions of the product, according to the requirements of the Commodity Inspection Bureau for the corresponding inspection and quarantine;
4, according to the product regulatory conditions, according to the Commodity Inspection Bureau for Corresponding inspection and quarantine;
5, customs declaration (with the bill of lading, customs clearance of goods entering the country, customs declaration application form or other documents required for product regulatory requirements)
6, customs acceptance; customs valuation (acceptance of the declared price through the customs or customs designated value or customs system query price consultation, etc.);
7, out of the tax (tariff stamps, value-added tax stamps), tax;
8, the terminal;
8, terminal pickup;
9, smooth customs clearance, release, transportation to the designated location.
The qualifications of the consignee of imported medical devices
1, medical equipment business license;
2, business license business scope of sale of medical equipment permit;
3, import and export rights if there is no qualified import and export company (emergo official website) agent to import
Imported medical equipment needs to be Provide documents:
1, the State Food and Drug Administration issued by the import of medical equipment registration certificate and medical device registration form;
2, belonging to the "implementation of mandatory product certification of medical devices within the product catalog", should provide China Compulsory Certification (3C); 3, some of the equipment required to apply for an automatic import license/O certificate;
4, photographs, nameplates, and other information.
4, equipment photos, nameplates, equipment, technical parameters, end use, Chinese manuals, etc.;
5, import contracts, packing lists, invoices;
6, other materials to be added.