On August 9, 2004, China State Food and Drug Administration (SFDA) issued new regulations for the registration of medical devices in China. These new regulations will simplify the application and dossier review process for medical devices. Additionally, the Medical Device Clinical Trial Regulation, effective April of this year, calls for more detailed requirements for clinical protocol, clinical hospitals and clinical reports in China.
The new regulations for medical device registration will make the process more transparent, and also speed up the overall review time for registering a medical device in China. Previously, a company prepared a dossier and then applied to the SFDA for a specification validation. This process took 1, 1½ months. Once the specification validation was reviewed and approved, the company sent samples to the testing center. The testing center required an additional 2-3 months for testing. With the new regulations, the dossier preparation and specification application processes have been combined into one step. The total processing time for all three of these steps dossier preparation, specification validation and sample testing is only 2-3 months.
Then, under the previous regulations, the company filed the dossier, with the approved specifications, and the official testing report to the SFDA. The SFDA would review the technical documents and issue the import license. With the new regulations in effect, the company still submits the entire dossier to the SFDA after testing. However, the SFDA sends the dossier to the Medical Device Evaluation Center (MDEC) to review the specifications, dossier, government certificate and clinical report. The MDEC sends their conclusion to the SFDA and then, if everything is acceptable, the SFDA will issue the import license. The MDEC review time, plus the SFDA final approval time, will still take about 4 months.
However, there are now several situations that can lengthen the new registration process. First, if the MDEC requires a supplement dossier, the company must complete the supplement and re-submit it to the SFDA within 60 working days. Second, since the specification validation is not required before testing, the testing is completed based on the company specifications. It is possible that the MDEC may request the company to revise its specifications and re-test, adding additional time and money to the registration process.