As a part of its 12th Five-Year Plan, the Chinese government has announced a number of policies intended to encourage local research and development on medical device products in order to reduce China’s dependence on importation of high-end and high-value device products. In furtherance of these policies, China’s newly restructured food and drug regulatory agency, the China Food and Drug Administration (CFDA), is developing a special pathway for review and approval of innovative medical device products.
In a draft regulation recently published by CFDA, the agency said that it intends to create a dedicated office, a dedicated database, and a dedicated expert panel to review and approve innovative medical device products, and to offer more flexibility in the review process. This special pathway would be more interactive and expedited than that for standard devices.
This pathway, however, will only be available to local device manufacturers and locally patented products; medical devices manufactured outside of China would not be eligible. Under the CFDA draft regulation, to qualify for this special review process, the applicant must be a locally-incorporated medical device manufacturing enterprise and have completed early stage research with a robust and complete traceable database, and the products must be made in China and exhibit fundamental improvements over current devices with significant clinical value. Significantly, the products must be protected by PRC invention patents that are either self-developed or licensed by the applicants.