Jun 14, 2016
The China Food and Drug Administration (CFDA) has set a July 15, 2016 deadline for distributors of higher-risk medical devices to submit self-inspection reports.
The reporting requirements (link in Chinese) pertain to distributors of Class II and III devices, and although the rules primarily affect distributors, there are ramifications for manufacturers as well.
In particular, distributors will need to check their distribution records going back to June 1, 2014 and report on:
Manufacturers should follow up with their Chinese distributors to discuss self-inspection results and take any appropriate actions.
Chinese medical device market regulators have more clearly defined the responsibilities of in-country representatives and limited exemptions for clinical evaluations in new rules, according to Emergo Group colleagues.
Chinese regulators have officially increased registration and related fees for Class II and III medical devices, according to the Chinese Food and Drug Administration (CFDA) and Emergo consultants in China.