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China tighten PPE export controls

New regulations announced last week by China’s Ministry of Commerce further strengthen the export quality supervision of on-medical use face masks, testing reagents, medical face masks, medical protective suits, ventilators and infrared thermometers, including a blacklist of suppliers which failed to gain export certification.

In Shanghai, there are reports of customs brokers raising rates for export clearance by up to six times, due to extra paperwork and processing time of these new processes, which are also impacting the Hong Kong, Guangzhou and Shenzhen regions.

We expect the same issues to extend to the rest of the country, as at least 90% of all medical cargo will require customs inspection.

There are also indications that the new export restrictions are preventing PPE manufactured in the mainland from transhipment in Hong Kong, and “more or less forcing” the cargo through mainland airports.

Effective from the 26th April 2020 the new China medical export controls enhance quality oversight and step up export regulation for epidemic prevention and control supplies of:

1. Non-medical use face masks
2. SARS-CoV-2 testing reagents, medical face masks, medical protective suits, ventilators and infrared thermometers

1. Non-medical use face masks will be required to conform with the quality standards of China or other countries and The Ministry of Commerce will provide a list of validated non-medical use face mask manufacturers who hold certification or authorisation from other countries.

(There is a separate list list of disqualified manufacturers that can be found @ www.samr.gov.cn)

Export companies must submit a joint declaration with the importer, as a confirmation that the products are compliant with the quality standards of China or other countries, and that the importer accepts the quality standards of the products purchased and does not intend them for medical purposes.

2. Exporters of SARS-CoV-2 testing reagents, medical face masks, medical protective suits, ventilators and infrared thermometers that have obtained certification or authorisation from other countries shall submit a declaration (see links), as a warranty that the products are compliant with the quality standards and safety requirements of the importing countries.

New China medical export control links

Non-Medical Use Face Masks Companies with Certification/Authorisation from other Countries

Medical Devices and Supplies Companies with Certification/Authorisation from other Countries

Joint Declaration of the Exporter and the Importer

Export Declaration of Medical Supplies

Announcement No.12 (2020): Enhancing Quality Oversight for Exported Epidemic Prevention and Control Supplies