IMDRF Work on Device Clinical Evaluations Unanimously Supported at China Meeting

Regulatory NewsRegulatory News | 28 March 2018 |  By 

Regulators worldwide came together at the 13th meeting of the International Medical Device Regulators Forum (IMDRF) in Shanghai, where they adopted a new work item – the first to have been proposed by China – to conduct research on clinical evaluations of medical devices on a global scale.

The global initiative for regulatory convergence and harmonization via IMDRF has attracted the attention of a growing body of member countries, with South Korea becoming the 10th participant last December.

Each of the countries has its own strengths and weaknesses in the device regulatory landscape, but these are leveraged accordingly while any competing objectives are set aside to allow for the discussions to be centered on harmonization of regulations, guidance and standards, Patrick Hope, chair of the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA), told Focus.

The efforts hold a lot of promise for industry and streamlining product approvals, Hope said.

China Food and Drug Administration (CFDA) – the current IMDRF chair – said last Friday in one of the several announcements on the meeting that its "Clinical Evaluation of Medical Devices" work item proposal was “unanimously supported by the participating members” and “successfully established.”

The international research project aims to explore the basic requirements for clinical trial decision-making and evaluation, including the acceptance of foreign clinical trial data, according to CFDA.

The project’s approval marks a “historic breakthrough since China has changed its role from a participant to a leader in the rulemaking of international standards recognition in the medical devices area,” CFDA said in a Wednesday update. “It also marks new progress made by China in continuously and in-depth promoting the Chinese experience in medical device standards management.”

FDA spokesperson Deborah Kotz confirmed to Focus that the proposed clinical evaluation work item – designed in collaboration with the Global Medical Technology Alliance (GMTA) – was approved during the management committee meeting.

Industry trade association AdvaMed led GMTA’s work with CFDA and US FDA to “move toward harmonization of clinical trial requirements” by establishing the new IMDRF work item, AdvaMed EVP of public affairs Greg Crist told Focus. The purpose of this work is “to provide guidance for regulators to determine when a clinical trial is needed and to allow for the use of foreign clinical data in submissions,” Crist said.

Both Kotz and Hope, who participates in DITTA through his position as the executive director of the Medical Imaging and Technology Alliance, noted that an outcomes report – which is typically issued following IMDRF management committee meetings – is expected to be posted soon. It may take a few weeks for CFDA to share this report but “we’ll know a lot more when this comes out,” Hope said.

Still, Hope highlighted other key takeaways from the meeting in addition to the new work item. These included a discussion on cybersecurity that Canada initiated as IMDRF chair last year, as well as a new conversation on artificial intelligence that CFDA sparked, and a closed work item on registries led by the US.

What’s next?

From a workshop on cybersecurity where about 150 people heard about different perspectives from regulators, industry and healthcare providers, the lesson learned was “there is a whole lot going on, but there is not a lot of coordination on all the activities happening in cybersecurity,” according to Hope.

DITTA – which also represents the China Association for Medical Devices Industry, and the Korea Medical Device Industrial Cooperative Association, among others – believes cybersecurity is one of the areas in which IMDRF should take a leadership role to “bring all regulatory agencies together to help make sure that we’re more cyber-secured,” Hope said, adding that this message was well-received at the meeting.

Another lesson learned related to artificial intelligence (AI) and the need to harmonize guidance and regulations. This is because not only is it an issue that will not just go away, but it is also one that has an international impact, Hope noted.

He also said the meeting made clear that developing standards on medical device AI is an issue of interest for CFDA. Premarket reviews of AI applications, particularly for brain diseases, are some of the topics that were discussed at CFDA’s open forum, though they just “scratched the surface.”

“It remains to be seen what the international community can do in artificial intelligence” as it is “still really early to find out what exactly, internationally, people are interested in looking at,” Hope said. Yet China, as the chair, will have some influence in whether this will become a work item in the future.


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