From foreign- to China-made medical devices

On 05.03.2020, the China NMPA (National Medical Products Administration) has launched a public consultation concerning the transfer of NMPA certificates of imported Class II and Class III medical devices and IVDs to a domestic enterprise for manufacturing in China. This measure would encourage foreign manufacturers to localize their approved medical devices in China in future.

According to the proposed regulation, the NMPA is simplifying the procedure for foreign enterprises to re-register their products – which must have initially been approved as an imported device – in order to claim their medical devices as domestically made in China. As hospital public tenders encourage domestic made products, foreign companies could benefit from this faster and easier way of relocating medical devices from overseas manufacturing sites to China sites once the announcement is officially implemented.
Since there is a great market potential for the medical device industry in China, the registration system and the quality standards are expected to continue to make significant improvements.

China NMPA will continue to solicit public opinions until 31.03.2020. Please provide your opinions to us before the deadline so we can submit a strong submission to the NMPA together.