If you are in the business of exporting or importing Personal Protective Equipment (PPE) or medical equipment from China during this COVID-19 pandemic, you need to be aware of the latest export requirements introduced by the Chinese Government. In this second article on exporting PPE/medical products out of China, we discuss the latest changes and their implications.
By now, if you have been trying to export or import PPE or medical equipment from China, you will be aware of the disruptions caused by Notice No.5 released on 31 March 2020. As a result of the unintended and extensive fall out which followed the Notice No.5 announcement, the Chinese Government released "Notice No.12 of 2020 – Notice on Further Strengthening Quality Control over the Export of Epidemic Prevention Materials" ("Notice No.12") on 25 April 2020. Notice No. 12 was issued jointly by the China Ministry of Commerce ("MOFCOM"), the General Administration of Customs ("China Customs") and the State Administration for Market Regulation ("SAMR") and has two parts, the first relating to non-medical masks, and the second to the COVID-19 related medical products referred to in Notice No.5.
Strengthening quality control over the export of non-medical masks
Notice No.5 did not apply to non-medical products, and this created two specific issues in the market. The first was that the export of non-medical products, such as non-medical face masks, were being caught by the increased scrutiny directed at exported medical products. The second issue was that some unscrupulous exporters were attempting to export medical products without appropriate certifications/registrations. Many importers ended up with non-medical masks and medical institutions were unable to obtain the critically needed medical grade product.
Notice No.12 is an attempt to balance the interests of various stakeholders and to ensure, as best as possible, the quality of the products being exported. As from 26 April 2020 the exporter and importer are required to make a joint declaration that their non-medical masks comply with product relevant quality standards of China or a foreign country. In the declaration, the parties are required to select, and specify, that their product meets either the Chinese quality standards or the foreign quality standards, as stipulated in their agreement. On a practical level, there are a number of potentially relevant standards, but two commonly referenced non-medical mask standards are:
- EN 149:2001 + A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
- Chinese Standard GB 2626 Respiratory protection - Non-powered air-purifying particle respirator
For the exporter and importer, a simple to understand bilingual (Chinese/English) joint declaration form can be found as Annex 1 on the Notice No.12 website announcement. An importer will be required to confirm acceptance of the product's stated quality standards and also confirm that the masks will not be used for medical purposes.
According to MOFCOM's official response to questions on Notice No.12, there will be two different regulating measures for the export of these non-medical masks.
Firstly, products conforming to foreign standards will be subject to "white list" management. MOFCOM will provide a list of companies that have obtained foreign standard certifications and publish this list on the China Chamber of Commerce of Medicines & Health Products Importers & Exporters website (www.cccmhpie.org.cn). The listing is voluntary and requires companies to supply a declaration and appropriate evidence to the local government commercial department to obtain such listing. Although voluntary, if a manufacturer is not on the list, product export will not be permitted, as China Customs will inspect and release goods based on the MOFCOM list.
If a non-medical mask only conforms to Chinese standards, they are not required to be included in the MOFCOM list for export, provided the importer accepts the Chinese product standard in the joint declaration.
Secondly, the website will provide a "black list" of unqualified non-medical masks and the companies who have been investigated and punished in the local market for manufacturing poor quality product. For companies not listed in the SAMR list, China Customs will accept the declaration and inspect and release their products for export accordingly.
One final point on the new requirements for non-medical masks, purchase contracts signed prior to 26 April 2020 (and still awaiting export) will also require the declaration to be completed and provided to China Customs.
Further regulating export of COVID-19 related medical products
Notice No.12 also relaxes the export restrictions placed on medical products with only foreign certifications or registrations as a consequence of Notice No.5. Under Notice No. 5, products could only qualify for export if they were registered with the NMPA in China (regardless of foreign registration status). As of 26 April 2020, however, products that only have foreign standard certification or registration (and no local registration) can now be exported if the exporter signs a declaration (in a form as set out in Annex 2 of the Notice No.12) that that the product will comply with the quality standards and safety requirements of the importing countries (regions).
As with the non-medical mask products, MOFCOM will list products and companies with foreign standard certifications or registrations (as per the website above) and companies with products that fit these criteria will need to voluntarily list their products through the local government commercial departments.
What this means for COVID-19 related product export
Notice No. 12 is welcome news to exporters, importers and final customers for non-medical and medical mask products.
For exporters, it removes some of the hurdles associated with exporting non-medical masks. For the importers of non-medical masks, while the new requirements will require them to sign declarations accepting the quality standards and confirming no medical use of the masks, it will provide greater confidence in knowing what product they will receive. In addition, the listing of both approved and potentially non-conforming products will assist in vetting potential suppliers.
For exporters of the medical products listed in Notice No.5 that have foreign but not domestic approval, Notice No.12 will assist them in being able to export these products from China.
Please click here for our previous article on China Imposes New Export Restrictions for COVID-19 Medical Products.
1 Notice No.5 of 2020 – Notice on the Orderly Conducting of Medical Materials Export