Prerequisites for customs clearance: consignee and consignor registration code (charities can be temporary code), the need to apply for paperless customs clearance legal person card; Export qualification: masks exported to the production and sales units, domestic consignors, in addition to meet the domestic production, market circulation qualification requirements, China Customs has no special qualification requirements. Export Declaration Requirements: 1. Commodity Classification: Except for special circumstances, the vast majority of masks should be categorized under tax code 63079000. 2. Inspection and Quarantine: masks are non-detectable products, declaration of inspection and quarantine items do not need to fill out. According to our government and the relevant countries signed an intergovernmental agreement on inspection, the export of Iran and a few other countries need to be in accordance with the provisions of the pre-shipment inspection of the product. 3. Tariff exemption: If the export of goods for the nature of trade, the nature of the exemption declared general taxation, tax exemption declared in accordance with the rules of taxation; such as the nature of the donation, the consignor of the territory of trade agents, charities, etc., the nature of the exemption may not fill in the exemption declared in the manner of full exemption. 4. Prohibition and restriction management: At present, the Ministry of Commerce has not set up trade control requirements for masks, and China Customs has not set up any port verification requirements for the supervision and control documents of protective materials. 5. Declaration of norms: Fill in the commodity name and content of ingredients according to the standard declaration requirements; if the materials are not produced in China, the country of origin should be filled in according to the actual country of production. Export tax rebate: The export tax rebate rate for masks is 13%. Domestic export trade enterprises need to have the qualifications and materials: 1. Business license (business scope with relevant business content). 2. 2. Enterprise production license (manufacturer). 3. Product inspection report (manufacturer). 4. Medical device registration certificate (non-medical need not). 5. Product manuals (provided with the product), labeling (provided with the product). 6. Product batch / number (packaging). 7. Product quality and safety certificate or certificate of conformity (follow the product to provide). 8. Product sample pictures and packaging pictures. 9. The trading company must obtain the customs consignee and consignor registration record. Domestic export mask manufacturer's qualifications: the production of personal protection or industrial non-medical device management of ordinary masks, import and export rights of enterprises, can directly export their own. The production of masks belonging to the management of medical devices for export, China Customs does not require enterprises to provide relevant qualification documents, but the general importing countries will require manufacturers to provide three certificates to prove that the imported goods have been legally listed in China, as follows: 1. Business license (business scope includes medical devices, non-medical level of the goods do not need). 2. Medical device product record certificate or registration certificate. 3.Manufacturer's test report. Manufacturers have the right to import and export, you can export on your own, if you do not have the right to import and export, you can export sales through foreign trade agents. Domestic trade enterprises to do exports need to obtain the basic qualifications: 1. To the market supervision department to obtain a business license, increase the scope of business "import and export of goods, import and export of technology, import and export agent. 2. To obtain the import and export rights from the commerce department, you can apply directly on the unified platform of the business system of the Ministry of Commerce, and submit materials online. 3. Apply to the Foreign Exchange Administration for permission to open foreign exchange accounts. 4. For customs registration of consignees and consignors of imported and exported goods. Article 9 of the Foreign Trade Law of the People's Republic of China*** and the State of China
Legal Objective:Measures for the Supervision and Administration of the Production of Medical Devices Article 7 to engage in the production of medical devices, shall have the following conditions: (a) there is the production of medical devices with the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel; (b) there is a production of medical devices to carry out quality testing (B) the production of medical devices for quality inspection of the organization or full-time inspectors and inspection equipment; (C) to ensure that the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capabilities; (E) in line with the product development, production process documentation requirements. Article VIII to open the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production permits, and submit the following information: (a) a copy of the business license; (b) the applicant company held by the production of medical devices, the certificate of registration and a copy of the technical requirements of the product; (c) legal representative, the person in charge of the enterprise Identity card Ming copy; (d) production, quality and technical personnel identity. (D) production, quality and technical personnel in charge of the identity, education, title certificate copies; (E) production management, quality inspection positions practitioners education, title list; (F) production site documents, special production environmental requirements should also be submitted to the facilities, environment, copy of the documents; (G) the main production equipment and inspection equipment catalog; (H) quality manuals and procedural documents; (Ix) (IX) process flow diagram; (X) the operator's authorization certificate; (XI) other supporting information.