CFDA recently organized a 3-day training session on In Vitro Diagnostics Clinical Evaluation and Trials in Beijing. Around 200 industry professionals participated in the event. Representatives from Brandwood Biomedical Beijing joined this session.
- Review on In Vitro Diagnostics regulations
- Requirements on In Vitro Diagnostics Clinical Evaluation
- Overview of In Vitro Diagnostics Clinical Trials in China
Be prepared for more audits on IVD clinical trials in China
CFDA has strengthened the audit checking on the IVD clinical trials in recent years. This will be further enhanced in the future. And the audit will gradually cover not only clinical sites but also the applicants. All trials are required to follow China GCP.
Planned amendment on IVD product registration regulation
CFDA Medical Device Registration Department is now working on the amendment on the current version of IVD product registration regulation. The draft amendment is planned to be completed for review in August 2018.
More IVD products to be on clinical trial exemption list in the near future
CFDA is considering including more IVD products on the clinical trial exemption list. Hopefully, we can see the draft of 4th wave exemption list coming out for public comments soon.
If you’re currently working through your CFDA applications for either IVD’s or Medical Devices, or are considering the China market for your product, please reach out to us for a free, no obligation discussion on how we may support you. Contact us for a free, no obligation discussion. Email firstname.lastname@example.org or call +61 2 9906 2984 (Sydney) or +86 186 0062 2341 (Beijing).