In August 2007, China’s State Food and Drug Administration (SFDA) issued six Working Procedures, laying out how it would conduct various procedural requests about medical device product registrations. The most notable of these was a detailed description of how to apply for extension of a registration’s expiration date while its renewal is delayed. Others included delaying product testing and obtaining a replacement for a lost product approval certification. Each Working Procedure includes how to qualify, what documents to submit, time limit for processing, and the SFDA’s handling process. They represent a much needed standardization given the delays in the Chinese regulatory system, which can sometimes be severe.
