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