Please tell me: what are the conditions needed to do the import and export qualification of Class II medical products?
1, the right to import and export
The right to import and export refers to the import and export enterprises to carry out import and export business qualifications. Enterprises applying for the right to import and export business only after getting the approval of the relevant departments such as the Municipal Bureau of Commerce, Municipal/Sub-district Customs, Inspection and Quarantine Bureau, Foreign Exchange Administration, Electronic Port, etc., and getting all kinds of certificates of approval from the above departments, only then does it mean that the enterprise owns the right to self-management of import and export. Only enterprises with the right of import and export can engage in import and export business independently according to law. It is also a necessary condition for foreign trade enterprises, regardless of whether the enterprise exports medical equipment, as long as the scope of business involves import and export will need to apply for this qualification.
2, the corresponding business or production qualifications
Business enterprise exports, if the business is the second class of medical devices, you need to apply for the second class of medical devices for the record, the third class for the medical device license; and production enterprises exports, you need to apply for the corresponding medical device registration certificate and production license according to the type of medical device, these are also necessary to handle the export of medical equipment products. These are also the necessary conditions for the export of medical equipment products sales certificate.
3, medical device products export sales certificate
Medical device products export sales certificate by the food and drug supervision and management department for approval, its main target is the medical device export trade enterprises, for the general need for information: medical device products export sales certificate registration form; a copy of the business license; medical device production license or a copy of the record certificate; A copy of the medical device product registration certificate or filing certificate, as well as the authenticity of the submitted materials and the content of the same self-assurance statement in English and Chinese.
Enterprises exporting medical devices, in addition to the need to apply for the above qualifications, but also should establish and maintain the export product files to ensure that the product export process can be traced. Specific file content includes has been handled by the medical device product export sales certificate and medical device export filing form, purchase contract, quality requirements, inspection reports, certificates of conformity, packaging, labeling styles, customs declarations and so on.
What is the process of import and export record registration?
Shenzhen company's import and export rights for the process:
1. Business license business scope of change: the company's business scope if there is no "import and export" or "import and export of goods and technology" words, you have to change the business scope. If the company is already registered with the words "import and export", this step is omitted.
2. foreign trade and economic cooperation for the record, to receive the "foreign trade record registration form" 3. customs record, for the record of consignees and consignees of imported and exported goods, to receive the receipt 4. electronic port, to receive the legal person card, etc. 5. Inspection and Quarantine Bureau for the record, to receive the receipt 6. foreign exchange bureau for the record, the opening of the foreign exchange management of trade in goods on the Internet, to receive the receipt of the right of import and export for import and export need to be prepared for the information: the original business license, corporate identity card, photocopy of the account opening license, the right of import and export for the information required to be prepared. Original legal identity card, a copy of the account opening license, official seal, corporate seal and so on.
Inspection and Quarantine Bureau for the record process?
1, the commodity inspection agency to accept the inspection. First of all, by the person filling out the "export inspection application", this process is the record. Commodity inspection for the record need to provide information: business license, a copy of the original, stamped; organization code, the original bank account, account number, contact person, contact information. After providing the relevant documents and information, such as foreign trade contracts, letters of credit, factory inspection results of the original single; commodity inspection agency in the review of the above documents meet the requirements of the acceptance of the batch of goods for inspection; if found to be not in line with the requirements of the applicant may be required to supplement or modify the relevant provisions.
2, sampling. By the commodity inspection agency staff presided over, according to the different forms of goods, take a random sampling method to take samples. Reporting person should provide the inventory location, and with the commodity inspection personnel to do a good job of sampling.
3, inspection. Inspection department can use a variety of technical means from the sense of the Palace to chemical analysis, instrumental analysis, etc., the export of goods for inspection, inspection in the form of commodity inspection, *** with the inspection, factory inspection and origin inspection.
4, the issuance of certificates. Commodity Inspection Agency for the inspection of goods issued inspection certificates, or in the "export goods declaration" on the seal of release.
Where to check the record of export enterprises?
Enterprises can log on to the "China Customs Enterprise Import and Export Credit Information Disclosure Platform", enter the name of the enterprise or the unified social credit code in the inquiry box of the platform, and click "Search". If the enterprise information appears, then the record has been passed, if it does not appear, then the record has not been completed or there is a delay in the delivery of public data; enterprises can contact the Customs and Excise Department to consult the record.