A recent training session to CFDA’s Center for Medical Device Evaluation raised a surprising plea. The agency is very open to risk based submissions for biocompatibility – but industry keeps on sending dossiers of test reports. So there you have it- CMDE have built it – will you come?
With more and more medical devices containing animal sourced materials, China’s CFDA is strengthening its Technical Guidance for animal derived biomaterials.
The long awaited refresh of US FDA’s biocompatibility guidance has finally arrived. This is a quantum leap from the old G95-1 Blue Book Memo. The guidance is firmly rooted in a risk based approach, and provides detailed advice on all aspects of biological safety evaluation. The controversial modified Table from ISO 10993 still remains, however parallel activities in ISO may see the new version of ISO 10993 coming into close alignment with FDA’s view.
FDA’s latest reviewer experiential learning program identifies new priorities for training. Hot button items are biocompatibility, clinical trials and emerging manufacturing technologies
There’s growing interest in modernisation of China’s use of international standards in medical device regulation. This is especially the case in ISO 10993 biocompatibility evaluation and 12 leading experts from ISO joined a full day workshop on Biological Evaluation of Medical devices in Guangzhou China.
Leading experts from ISO, along with Senior regulators will meet in Guangzhou in September to discuss evolving approaches to biocompatibility evaluation. In a special workshop at the China International Medical Device Regulatory Forum, the experts will discuss the planned changes in ISO 10993 norms, including greater reliance on chemical characterisation, reduction in animal models and a strengthened risk management framework.