China Enhancing Quality Inspection for Exported COVID-19 Medical Devices

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China Enhancing Quality Inspection for Exported COVID-19 Medical Devices

Premier Li Keqiang of China, center, speaking at the Jinyintan hospital in Wuhan/ Reuters

The Chinese government is moving to enhance quality inspection and export supervision for domestic COVID-19 related medical devices. The Ministry of Commerce, General Administration of Customs, and State Administration for Market Regulation (SAMR) jointly announced these plans on April 25.

The announcement directs the following to take place:

  • China‚Äôs Ministry of Commerce publishes a list of certified non-medical use face-mask manufacturer, updated daily;
  • SAMR provides a list of disqualified non-medical use face-mask manufacturers;
  • Before providing export clearance, Customs needs either Joint Declaration of the Exporter and the Importer, or Export Declaration of Medical Supplies.

China manufacturers with export certification of COVID-19 related medical devices, as of May, 6, include:

  • Medical face masks (76 manufacturers)
  • Medical protective gowns (56 manufacturers)
  • Ventilators (14 manufacturers)
  • Infrared thermometers (13 manufacturers)
  • Coronavirus reagent test kits (120 manufacturers)

As China enhances quality inspection for exported COVID-19 medical devices, overseas companies have the ability to confirm whether Chinese manufacturers are on the approved export list. Please contact China Med Device if you need help in this area.


About China Med Device, LLC

China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.