During the review process, the NDAC will give priority to the innovative medical devices with Chinese intellectual property rights, capable of leading the way at an international level, and a significant clinical application value, as well as to the products that support major national technology projects, key research and development plans, and are approved by the state clinical medical research center for clinical trials and by the central management departments.
The China State Council lately allowed the registration of applicants for medical devices in the Guangdong and Tianjin Free Trade Pilot Zones to entrust the provincial or municipal manufacturers to produce the devices.
The reforms for the device registrant system will help to integrate the resources in the medical devices industry, optimize the allocation of resources and enhance a rapid release of production capacities.
On the other hand, allowing to entrust other manufacturing companies will help startups focus on the research and development of their products, rather than spending the resources on plant investments in the early stage of their business. It will also accelerate the speed of entry for newly approved medical devices in joining the market and encourage companies to focus on their innovations.
China has emphasized the innovative development of medical devices. There will be more supporting documents and policies, which will further improve the international integration of related standard systems. Domestic medical imaging devices are gradually replacing foreign medical devices.
The high-end domestic medical devices are facing more development opportunities. In the past two years, the domestic demands for high-end local medical devices have been gradually increasing, and the relevant leading companies have achieved a surprisingly high growth rate.