COVID-19: China’s expansion of quality controls regarding export of medical products (part 2)

Exports of medical devices and personal protective equipment (PPE) such as masks and protective clothing from China have increased sharply due to COVID-19. Following media reports on defective products arriving in Europe from China, the Chinese government began tightening export conditions and export controls for relevant product groups at the end of March 2020 (see article here for more information). In some cases, the new regulations led to considerable challenges for foreign companies and exporters. In response to these problems, the Chinese side modified the regulations at the end of April 2020.

Tightening of quality controls on Chinese exports

On 31 March 2020, the Chinese Ministry of Commerce (MOFCOM), the General Administration for Customs (GACC) and the National Medical Products Administration (NMPA) jointly declared to expand controls on the export of certain medical products (MOFCOM / GACC / NMPA Notice No. 5 2020). Since 1 April 2020, exporters of five categories of medical devices (1. COVID-19 test kits, 2. medical masks, 3. medical protective clothing, 4. respiratory equipment and 5. infrared temperature measuring devices) had to present a valid Chinese NMPA-license at customs declaration and submit a self-declaration that the exported products meet the quality standards of the destination country. Export controls and release of the products by Chinese customs authorities was based on the NMPA approval certificates. Furthermore, on 10 April 2020, GACC declared that Chinese customs authorities will conduct additional export inspections for eleven categories of medical devices (including medical masks, ventilators and patient monitors; GACC Announcement No. 53 2020; see article here, for more information).

 

However, many international manufacturers of medical products operate in China as contracted manufacturers, producing exclusively for foreign markets. As such, these export products do not have NMPA approval for the Chinese market. Therefore, many such products could no longer be exported.

Adjustments of the regulations

In response to these problems, MOFCOM, GACC and the State Administration for Market Regulation (SAMR) modified the export regulation for the affected categories of medical devices on 26 April 2020 and issued additional regulations specifically for non-medical masks (MOFCOM / GACC / SAMR Order No. 12 2020):

 

As of 26 April 2020, the affected medical devices can be exported without an NMPA license. Exporters must submit a declaration to the customs authorities, specifying that the products have foreign approval certificates / proof of conformity (with indication of corresponding norms / standards) and that they meet the quality and safety requirements of the target market. Export controls and release of the products by Chinese customs authorities is carried out based on a positive list provided by MOFCOM. The list includes companies that possess corresponding foreign approval certificates / proof of conformity and is administered by the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE; see website for the current version of the positive list).

 

Since 26 April 2020, non-medical masks must meet either Chinese or foreign quality standards when exported. Exporters, together with the importer, must make a joint declaration to customs that the products meet the quality standards of China or the target market (with indication of relevant norms / standards). With the declaration, the importer guarantees that the product quality standards contractually agreed between the parties meet the quality requirements of the target market and that the importer accepts the quality standards of the products in question. Furthermore, the importer declares not to use the procured masks for medical purposes and to inform third parties that the masks cannot be used for medical purposes. However, the practical applicability of this provision is disputed. Finally, the declaration contains an exclusion of liability for the exporter or the manufacturer. The export control and release of non-medical masks by the Chinese customs authorities is also carried out based on a second positive list provided by MOFCOM and based on a negative list provided by SAMR, including companies or products for which non-conformity with applicable quality standards has been established in the course of spot checks on the Chinese market. The positive list for non-medical masks is also managed by CCCMHPIE (see CCCMHPIE website for the current version of the positive list).

 

In addition to Order No. 12, MOFCOM published a notification on 26 April 2020 for the administration of the aforementioned positive lists. Companies must send appropriate evidence to the competent authorities at local level to be included on the respective lists. Attached to MOFCOM’s notification is further information on the documents required for exporters of non-medical masks and affected medical devices (see appendix for unofficial translations of the information regarding required documentation ). According to CCCMHPIE, the process normally takes about two weeks. The lists are updated weekly. In the versions of 25 and 26 May 2020, respectively, the lists include 557 companies for medical masks, 113 for medical protective clothing, 32 companies for respiratory equipment, 64 companies for infrared temperature measuring devices and 188 companies for COVID-19 test kits, as well as 97 companies for non-medical masks, which according to the Chinese side's tests have valid foreign approval certificates / proof of conformity.

 

See German version here.