New China Face Mask Requirements – Notification No. 12 – Declarations for Export Customs

  • New China Face Mask Requirements – Notification No. 12 – Declarations for Export Customs


    To date, China has released 3 separate notices on medical supplies manufactured for export since April 1st. On April 25th, China release supplement to Notification No. 5, named Notification No.12 in an attempt to strengthen controls on product quality and assist in standardizing the order of export procedures. The initiative’s goal is to assist manufacturers in simplifying  the China export customs declaration,  who are listed on the White List, but do not have production permits.

    The focus of Notification 12 pertains to non-medical masks. The Chinese government has been maintaining both a White List and a Black List.  Any supplier on the Black List  is banned from exporting any medical supplies from China to any country. The more can be found on the State Administration Market Regulation (SAMR) website.

    They have also issued declaration forms (attached below) that must be completed and jointly signed by the importer and exporter stating the quality standards of the products are compliant and will not be used for medical purposes.

    Declaration Form 1
    Declaration Form 2

    1. Non-medical Face Masks
    Manufactures/Exporters who have obtained any overseas license or certificate and are on the White List of HPIE, Import & Export of Medicines & Health Products, (www.cccmhpie.org.cn) are permitted to export non-medical face masks as long as they have never been on the Black List of SAMR. They are required to provide the Joint Declaration of the Exporter and the Importer,  in their export customs declaration.

    2. Medical Supplies
    Manufacturers who have obtained any overseas license or certificate and are on the White List of  the HPIE (www.cccmhpie.org.cn) are permitted to export medical supplies and are required to provide the Export Declaration accordingly.

    We encourage all clients involved in Face Masks, or any PPE medical supplies, to carefully review the requirements and communicate with their suppliers to assure that they compliant.  The Declarations required for both parties to complete and sign are included below for quick reference.

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