Chang-Hong Whitney10.06.06
It is obvious that with all the steps involved in the testing process, this new regulation presents great challenges to manufacturers of electrical medical devices—especially to those who already have products in the registration process. They are caught in the middle and must hurry to provide additional information or conduct further tests as soon as possible.
If a full IEC report is available, it must be validated by the SFDA testing center that conducted the product testing in the past. Companies will need to compare the IEC report with the type-testing report and explain any discrepancies between the two reports. In addition, the original product standard needs to be updated according to IEC requirements. Such tedious comparisons and explanation can be time consuming due to issues caused by testing under different conditions. Before submitting to the SFDA, all foreign language documents (such as testing reports) must be translated into Chinese.
Based on the current implementation requirements, clearly further review and improvements need to be made for the process to be more effective and simple. Some steps (such as the validation review and translation) seem to be redundant and unnecessary. And some registration review agents have exhibited a lack of in-depth understanding of both the standard and technical details.
Furthermore, some requests seem unreasonable or technically illogical. Lack of clarity and definitions in the regulation also has left room for individual interpretations, causing inconsistency in implementation.
Finally, the flood of documents and test requests in response to the regulation may have caused bottlenecks in the registration agencies, generating extensive delays.
While it seems to be a difficult time for manufacturers of medical electrical or electronic devices, we should all hold onto hope that the SFDA will make a concerted effort to further streamline its systems and requirements. Ideally, the early pain and chaos will subside and a smoother transition will emerge in the future.