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?
China continues to grow and interest remains as active as ever. Grant Bennett takes a look at the China regulatory pathway and the challenges along the way.
Although the Europeans have retained risk classifications and 3rd party conformity assessment based on risk class, the new MDR changes almost everything. In more than ten times as many words as the MDD and AIMD, the new regulations provide much more detailed requirements and set a higher bar especially in clinical evidence, postmarket monitoring and risk management, integrating all of these into a single living process. The race is on for the three year transition period – it’s going to get busy…
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.
For years, manufacturers have had to take two approaches to labelling. In the US, FDA have insisted that symbols are accompanied by words to describe their meaning, whereas the rest of the world has been happy to use symbols alone. This means US labels are necessarily more complex, and some would argue, less effective. All this is about to change as FDA finally embraces the use of stand alone standardised symbols.