China’s newly restructured food and drug regulatory agency, the China Food and Drug Administration (“CFDA”), has published new draft rules to simplify the re-registration of medical devices that have already been approved for marketing in China. Re-registration is a substantial review process applied by CFDA in approving product license renewals as well as significant changes in approved products.
According to the draft regulation published on March 20, CFDA intends to focus its re-registration review on changes that have been made in the relevant products and require manufacturers to provide documentation to establish the efficacy and safety of such changes. Manufacturers would no longer be required to submit documentation in their re-registration applications in connection with those products where no significant changes have been made. However, significant changes to product structure and design, major material alterations, or other significant changes that may affect product safety and efficacy would require a new product registration.
CFDA also emphasized that product re-registration documentation must include a device vigilance report that consolidates and analyzes adverse events associated with the products.