On February 7, 2014, the China Food and Drug Administration (CFDA) issued a new regulation to formulate a special pathway for review and approval of innovative medical device products, which regulation will become effective from March 1, 2014.
Under this regulation, a special approval pathway will be available for innovative medical device products that are manufactured in or outside China, to the extent that the following requirements are met simultaneously:
- Key technologies of the product are protected by Chinese invention patents that are lawfully owned by or licensed to the applicant, or the relevant invention patent applications have been published in China;
- The product is “first in China” in terms of its key functions or working mechanism, and exhibits fundamental improvements over current devices with significant clinical value; and
- The early stage research of the product is completed, the research process is true and controlled, and the research data is complete and traceable.
CFDA will establish a dedicated office and a dedicated expert panel to review and approve innovative medical device products that are qualified for such review. The products under special review will be given priority in areas such as type testing, technical review, QMS certification, and the review timeline could be shortened to approximately 60 working days for local products and 40 working days for foreign products. The applicants will also be given more opportunity to communicate with CFDA in the review process.