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News & Knowledge

New export requirements for ‘PPE’ in China

27th April 2020

Pamir Law Group

On 31 March 2020, China issued the “Notice Regarding Orderly Development of Medical Goods Exports applicable to the exports of Private Protective Equipment (“PPE”)”, effective 1 April 2020 (the “Notice”). MSI's Taiwan law member Pamir Law Group provides further information.

The Notice is intended to insure the quality of PPE by requiring that Chinese manufacturers of PPE have proper certifications by the State Food and Drug Administration (“SFDA”) and that the manufacturers be listed in the national medical products registry maintained by the SFDA.

The PPE categories covered include the following types of products for fighting coronavirus which require verification:

  • Coronavirus Testing Kits
  • Medical Protective Outfits/Gowns
  • Medical Protective Masks
  • Surgical Masks
  • Disposable Medical Masks
  • Ventilators and

Special Goods”), and therefore require an Export Health and Quarantine Permit (“EHQP”) issued by the SFDA for export.

The exporter must provide the following documents before shipping to the customs office, which then coordinates with the SFDA officials to verify the contents:

  • Application Form for Examination and Approval of Entry and Exit Health Quarantine on Special Goods (”Application Form for Approval”)
  • Descriptions of the special items, including English names, categories, ingredients, sources, uses, major sales channels, countries or regions where they are exported, manufacturers,
  • If the special items contain or may contain pathogenic microorganisms, the name of the pathogenic microorganism (Chinese and Latin), the explanatory documents of biological characteristics (Chinese and English) and the supporting documents of the corresponding level of biosecurity prevention and control of the production operator or user shall be
  • Biological products or human blood products for the prevention, diagnosis and treatment of human diseases abroad shall provide a free sales certificate issued by the drug supervision and administration department
  • If the special goods of export involve the management of human genetic resources, the approval documents issued by the management department of human genetic resources shall be
  • Special goods that contains or may contain pathogenic microorganisms, exporters shall provide a biosecurity laboratory qualification appropriate to the biosecurity risk level, and laboratories above BSL-3 levels must be approved by a national authorized institution
  • If the special goods contains highly pathogenic microbial bacteria (toxic), species (toxic) or samples, exporters shall provide the approval documents of the competent department of health of the government at or above the provincial level

The SFDA will render a decision on the EHQP to the manufacturer within 20 working days.

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