Regulations the world over are under intense scrutiny and almost everyone is undertaking reform.
But what’s actually changing? That’s the question I tried to answer when speaking at the China International Medical Device Regulatory Forum (CIMDR) in Guangzhou last month. The first day was packed with presentations from senior regulators in Asia, the US and Europe explaining all the big changes in their systems. I got to round this off with a comparison of the major trends.
In preparing my presentation I was struck by two things:
- Everyone’s making the same changes – and in most cases they are adjustments, not radical shifts of direction.
- The fundamental core of regulatory systems are not changing.
What do I mean? Well if you look at the recent overhauls of regulation in Japan and China and the proposed changes in Europe, and the recent Expert Report into Australia’s TGA, there are a set of quite common actions.
Firstly everyone’s beefing up clinical evidence requirements especially for higher risk devices – where direct clinical trials are becoming the default expectation. This is a worldwide response to high profile device failures such as the ASR hip where the level of clinical evidence supporting market release has been questioned. This is not a new thing – the Europeans strengthened clinical evidence requirements in the 2007 update of the directives. For Europe, this is a further increment in that process. In China the changes impose stricter requirements – but again the theme is stronger requirements for higher risk devices, with exemption lists for many medium risk devices
In Europe, (and to some extent in Australia), there is a push to strengthen the Third Party Assessment system, with more rigorous requirements for Notified Bodies and stronger assessments including unannounced audits (the latter in response to the PIP breast implant scandal).
But what is also striking is that 3rd Party Conformity Assessment is here to stay. The governance and rigour is being strengthened – but nobody currently using 3rd Party assessment is suggesting removing them, and some markets – notably Japan are extending the use of 3rd party Assessors. The TGA Expert Review while calling for more governance and transparency in accreditation also called for extending use of third parties.
The rest of the changes are really about adjustments and better process: tweaking the classification systems to take into account experience and new technologies, and relaxation of requirements and streamlining back office processes for lower risk devices. We have seen TGA and China move to notification only for Class I devices, China has invested heavily in back office workflow software and electronic lodgement systems and most agencies seeking to smooth the review pathway for lower risk devices.
The one emerging new trend is the implementation of expedited pathways for new technologies as regulators respond to charges that they are stifling innovation. Although take note – most agencies are providing extra help to innovators and priority queueing but nobody is seriously suggesting a lowering of the bar – especially given the higher risk profile of new and untried technologies.
But most striking of all are the things that are not changing.
- No-one is Moving away from the existing risk based classifications
- No-one is abandoning design controls (in fact they are being extended in some jurisdictions especially Japan)
- No-one is walking away from use of ISO 14971 Risk management as a foundation of design and development and of regulatory review
- Everyone is continuing to use international standards and these are becoming more harmonised (witness FDA’s continuing commitment to their recognised standards program as well as China’s stated objective to update and harmonise 500 standards in the next 5 years)
- And in all jurisdictions that use them – the Essential Requirements which underpin the regulatory requirements are unchanged. (Note that it’s not just Europe, Canada and Australia – the Essential Requirements are found in some form within regulations in China, Japan and much of Asia).
So although it’s true that regulations are being tightened – largely in response to public concerns about high profile device failures and scandals, the reforms are largely incremental – involving stronger policing of high risk devices -especially in areas of clinical evidence, combined with streamlining things at the low risk end of the spectrum, and special favours for innovative devices.
But the fundamental building blocks of global devices regulation, Essential requirements, consensus standards, risk management and design controls and use of 3rd party assessors have stood the test of time. It wasn’t broke and by and large nobody’s fixing it.
To download a copy of the slides of my CIMDR presentation click the following link : Harmony with Strength – Global Trends in Regulatory Reform
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