Chang-Hong Whitney11.12.07
Comparing this new draft with the existing regulations, this regulation addressed many key issues and completed the designation of supervision responsibilities to the full spectrum of players in the medical device supply chain. The new regulation’s emphasis on quality management has been reflected through the SFDA’s activities in the past two years, and the attempt to shift the focus on product safety and efficacy—although minor—still is a welcoming signal that the agency is trying to align with internationally accepted practices. The shift eventually will benefit many new products—such as convergent technology or patient-specific implants—that face tremendous difficulty in gaining market approval in China.
One major subject that was highly anticipated but did not appear in the new regulation is the renewal of product registrations. It was widely anticipated that the SFDA would relax its renewal criteria in the new draft. However, given the rapid development of new technologies in the medical market, as well as changes in Chinese regulations, it is questionable that the agency would forego its right to re-evaluate products on the market at the time of registration renewal.
From the perspectives of international companies that sell products to China, this new regulation does not seem to present additional challenges at this point. Class I products should achieve faster turnaround at registration. On the other hand, Class II and III products—especially implantable and sterile products—may see additional requirements in product testing and documentation for registrations. For companies that operate Chinese manufacturing facilities, manufacturing permits and product registrations also will be more complicated and treacherous, as they will need to deal with provincial FDA offices for design review before approaching the SFDA for final registration. It could be a lengthier process than is seen with the current system.
In summary, this new regulation has a few added dimensions that certainly will generate many subsequence regulations in the future and eventually reshape the landscape of medical regulation in China. Although it is always important to “go by the book” in China, one also should make sure to “read between the lines” and anticipate the next logical request from regulatory officials.