The new requirements cover medical and non-medical supplies
China has implemented additional inspection requirements for exports of medical and non-medical supplies in an effort to more effectively support the international community in coping with the global public health crisis.
Medical Supplies
Scope of covered products: COVID-19 test kits, medical masks, medical protective clothing, ventilators, and infrared thermometers
As of April 26, export enterprises that have obtained certification or registration of foreign standards must provide the following information to customs authorities:
- Electronic or written export declaration of medical supplies
- Commitment that the product meets the quality standards and safety requirements of the importing country
China’s Ministry of Commerce has published a list of manufacturing enterprises and products that have been verified or registered overseas, which is available at www.cccmhpie.org.cn.
Non-medical Masks
Scope: Non-medical face masks
Effective April 26, all non-medical masks must meet the quality standards of either China or the respective import destination. Exporters of non-medical masks must submit an electronic or written joint declaration by both the exporter and importer confirming that:
- The product complies with China’s quality standards or foreign quality standards
- The importer accepts the quality standards of the purchased products
- The importer will not use the products for medical purposes
For purchase orders signed before April 26, both the exporter and importer must submit an electronic or written joint declaration during the export declaration.
The Ministry of Commerce has published a list of non-medical mask manufacturing enterprises that have been verified or registered overseas, which is available at www.cccmhpie.org.cn.
A list of products and enterprises that do not meet the quality standards or that are the subject of a domestic market investigation is available on the General Administration of Market Supervision’s website located at www.samr.gov.cn
Potential Impact
Importers should anticipate delays in their shipments of medical supplies and PPE as customs processes the export declarations. Importers of non-medical masks could experience significant delays as the majority of non-medical masks enterprises do not have joint declarations of the exporter and the importer, and some orders may be cancelled by China’s Ministry of Commerce if the products do not conform to the new standards.
Is My Mask Considered Medical or Non-medical?
As it can be confusing to differentiate between the two categories, the guidelines below will help you determine whether your masks are considered a medical or non-medical supply. These guidelines are applicable to all product description materials, including inspection certificates, packaging (both external and internal), user manuals, etc., as well as the product itself, regardless of the language used
- Face masks are considered a medical supply if the “FDA” mark is indicated
- Face masks not considered for medical use are indicated by the European CE mark and the KN95 standard (e.g., EN149-2001 + A1:2009 (CE) and GB 2626-2006 (KN95))
NOTE: If the product description lists conflicting standards, the higher standard will prevail. For example, if the outside package lists both FDA and CE, the product will be deemed a medical supply.
To review the joint announcement by Ministry of Commerce, General Administration of Customs (GACC), and State Administration for Market Regulation, click here. While the announcement is published in Chinese, if you click on the Google Translate button, you can review it in English.
For more information on importing PPE or medical supplies from China, please contact a member of our Compliance Department at Compliance@oceanair.net.
For assistance in importing PPE or medical supplies from China, please contact a member of our Sales Department at Sales@oceanair.net.
