The 6th China International Medical Device Regulatory Forum held in Guangzhou, China last month featured a special workshop on Biological Evaluation of Medical Devices. This was the second time CIMDR had held this workshop and this year it expanded to a very full day of speakers. Most importantly the event included 12 Senior experts drawn for ISO Technical Committee 194 – the body that writes the ISO 10993 series of standards. I was honored to be able to assist in organising the event and co-chaired along with ShiXin Li, Director of CFDA Evaluation Division II and a lead authority within the agency on biocompatibility standards and evaluation.
The workshop was wide ranging – covering the risk management model underlying biological safety testing as well as specific topics such as exploring the increasing importance of chemical characterisation, the special cases of tissue engineering and animal origin materials. Almost all major parts of the ISO 10993 series are currently under revision and several of those changes were explored in detail including aspects such as blood compatibility testing.
Although ISO 10993 is an international consensus standard, regrettably it is subject to much variation in local interpretation. Different regulators take different positions on the extent of testing required and the specific test methods which are acceptable. This was eloquently explained in a paper from Rob Przygoda who compared testing requirements across multiple jurisdictions both East and West.
The ISO committee is acutely aware of the idiosyncrasies of implementation of the 10993 standards. It’s currently devoting a great deal of effort and energy into updating the standards and in particular clarifying the standards to promote greater consistency in their use as well as use of state of the art practices of evaluation, testing and risk management.
The strong support for this workshop from the CFDA and its training arm the CCPDIE is significant. Biological evaluation in China continues to be problematic, with reviewers taking cautious approaches to testing, insistence on much repeated testing within China and local interpretations of the requirements. However there is a real commitment to engagement, learning and update of practice which is part of a broader modernisation of China’s use of international standards in devices regulation. The interest was palpable. The very many audience questions and discussions inevitably caused the already long workshop to run late – and there was still standing room only in the room at 6:30 pm when the rest of the conference had gone to dinner.
From the presentations at Guangzhou it’s clear there are big changes underway in the ISO 10993 series. The Part 1 standard is being updated to take into account the latest risk management approaches embodied in ISO 14971. The extensive guidance in ISO TR 15499 will most likeley be incorporated completely within Part 1 as an informative Annex. There are updates in many of the primary test standards – including some changes which seek to replace animal models (e.g. for irritation) with in vitro models. The power of modern analytical chemistry means there is a shift towards use of chemistry as a more powerful tool than biological assays in some cases. Also as analytical techniques become more and more sensitive, there’s discussion on when to discount small traces of substances which are not present in sufficient quantity to cause a hazard – in other words – can we define a Threshold of Toxicological concern below which we don’t assess toxicity. And as they say in the commercials – there’s more, much more. So watch out for upcoming changes to ISO 10993 documents- or support your national standards Association to become directly involved.
The Workshop is planned to run again next year – with plans for some deeper dives into areas of practice and even more audience participation. Be there – watch www.cimdr.com for details.
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