Mar. 1, 2014
As the Chinese Food and Drug Administration (“CFDA”) has announced, special procedures for fast-track evaluation and approval of innovative medical devices have come into effect on March 1, 2014.
According to the new regulations, eligibility for fast-track evaluation is subject to three conditions: the applicant must legally hold the patent or its use-rights in China; the product is first of its kind in China, technologically superior and clinically advantageous over existing devices; and the applicant must have completed the preliminary research and finalized the design of the product.
The priority review is expected to shorten the entire approval process to about 160 days, compared to 1-2 years beforehand.