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On the evening of April 25, the Ministry of Commerce’s website released an announcement titled “Announcement No. 12 of 2020 of the Ministry of Commerce, the General Administration of Customs and the State Administration for Market Regulation on Further Strengthening the Quality Supervision of Export of Epidemic Prevention Materials.” Export requirements for epidemic prevention materials upgraded It has been less than half a month since the release of Announcement No. 5 by the three ministries and the follow-up implementation of Notice No. 53 by the Customs. The Announcement No. 12 suddenly issued by the three ministries in the evening of April 25 can be said to be the most stringent measure on the export of epidemic prevention materials, mainly masks. Now even non-medical masks are not "let go"! The announcement stated that in this special period when the global epidemic continues to spread, in order to more effectively support the international community in jointly responding to the global public health crisis, the following measures are hereby announced to further strengthen the quality supervision of epidemic prevention materials and regulate the export order: 1. Strengthen the quality supervision of non-medical masks for export. From April 26, non-medical masks for export must meet Chinese quality standards or foreign quality standards. The Ministry of Commerce confirms the list of non-medical mask manufacturers that have obtained foreign standard certification or registration (dynamically updated on the website of China Chamber of Commerce for Import and Export of Medicines and Health Products www.cccmhpie.org.cn), and the State Administration for Market Regulation provides a list of non-medical mask products and companies that have substandard quality investigated and dealt with in the domestic market (dynamically updated on the website of the State Administration for Market Regulation www.samr.gov.cn). When declaring customs, non-medical mask exporters must submit an electronic or written joint declaration from the exporter and importer to confirm that the products meet Chinese quality standards or foreign quality standards, and that the importer accepts the quality standards of the purchased products and that they are not for medical purposes. Customs will verify and release them based on the list of companies provided by the Ministry of Commerce. For companies not on the list provided by the State Administration for Market Regulation, the customs will accept the declaration and verify and release them. For purchase contracts signed before April 26, an electronic or written joint declaration by the exporter and importer must be submitted when declaring export. 2. Further standardize the export order of medical supplies. Starting from April 26, exporters of novel coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers whose products have obtained foreign standard certification or registration must submit a written declaration when declaring customs, promising that the products meet the quality standards and safety requirements of the importing country (region). Customs will inspect and release them based on the list of manufacturers that have obtained foreign standard certification or registration provided by the Ministry of Commerce (dynamically updated on the website of the China Chamber of Commerce for Import and Export of Medicines and Health Products www.cccmhpie.org.cn). No domestic registration certificate is required for the export of epidemic prevention materials In addition, the three departments also made it clear that from April 26, exporters of novel coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers whose products have obtained foreign standard certification or registration must submit a written declaration (see Appendix 2) when declaring customs, promising that the products meet the quality standards and safety requirements of the importing country (region). Customs will inspect and release them based on the list of manufacturers that have obtained foreign standard certification or registration provided by the Ministry of Commerce (dynamically updated on the website of the China Chamber of Commerce for Import and Export of Medicines and Health Products www.cccmhpie.org.cn). In other words, starting from today (April 26), the export of five types of epidemic prevention materials, including new coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers, will no longer require a domestic registration certificate, but only require foreign standard certification. This is undoubtedly a great benefit for some companies that have obtained foreign standard certification. Precautions and requirements for export of non-medical masks In fact, the customs has recently increased the intensity of inspections on masks, and the inspection requirements and the compliance with established rules have been updated rapidly. The following are some precautions for non-medical mask certificates and packaging, for reference only.
Notes for non-medical masks: 1. Each small package/box in the goods must have a certificate of conformity (must be stamped). The product or packaging or certificate of conformity must have: the name of the production factory, product name, specification model, implementation standard, production batch, production date, shelf life, ingredient material, manufacturer, production address, quality inspection stamp, etc. (all are indispensable) 2. Non-medical masks must comply with non-medical standards, and the product packaging cannot have FDA and CE EN14683 logos printed on it. Medical words (in Chinese and English) cannot appear on the packaging of non-medical masks, such as "Medical" or "Surgical" or "Medical" in English. Any of the above words, standards, and logos are medical masks. 3. The ingredients printed on the mask are in percentage (preferably according to the medical device registration certificate, if not available, you can follow the test report, the sum must be equal to 100%. For example, non-woven fabric 40%, meltblown fabric 30%, filter cotton 30%). 4. The name of the manufacturer must be displayed on the product, packaging or certificate of conformity (the English name requires the operator registration certificate). 7. The product must have a color box, i.e. sales packaging Non-medical export requirements: When exporting civilian masks and civilian protective clothing, enterprises need to provide the following when declaring to the customs: 1. Manufacturer's business license 2. Letter of Commitment (The letter of commitment needs to be stamped by the consignor, and the original should be scanned as much as possible) 3. Non-medical statement (the shipping company needs to stamp the official seal, as clear as possible, otherwise there is a risk of return order and retransmission) 7. Customs declaration letter 8. CE certification recognized by EU countries, etc. 10. Product inspection report 12. Certificate of Conformity (one certificate should be placed on each box of actual goods, with stamp) 13. (Non-medical) Respiratory protective equipment GB2626-2006 In addition to providing comprehensive required documents, there are also specific requirements for packaging: 1. The packaging must be labeled "non-medical". There is no limit to the written language of non-medical labels, but they must be present. 2. FDA cannot appear on civilian (non-medical) packaging. Because the FDA logo is a medical logo, the U.S. civilian (non-medical) standard is registered with the U.S. NIOSH and has nothing to do with the FDA, so civilian use of the FDA logo is basically a fraud. 3. CE and KN95 can be printed. CE and KN95 can be printed as long as the corresponding technical standards are non-medical. The non-medical standard of CE is: EN149-2001+A1:2009, and the non-medical technical standard of KN95 is: GB2626-2006. 4. The certificate of conformity shall contain the following information: Product name, model specification, production batch number, production date, expiration date, technical standards, material, manufacturer, ingredient content. The above information must be printed and written in full, regardless of language, and will not be valid if posted externally. 5. The packaging should be based on retail packaging standards. Simple bulk packaging is not acceptable and must be packaged in standardized bags or boxes. 6. The stamp on the test report must be consistent with the factory stamp on the certificate of conformity, and the official seal must be red. Enterprises are the primary responsible parties for the quality and safety of exported medical supplies, and customs shall implement inspection and supervision in accordance with the law. The export of adulterated, counterfeit, inferior goods, or unqualified imported and exported goods passed off as qualified ones will be severely investigated and dealt with in accordance with the law; if a crime is constituted, criminal liability will be pursued in accordance with the law. The above information is for reference only. We hope that everyone can provide qualifications and export correctly in accordance with customs requirements.
Source: Seller Growth Academy |
