Over the past few months, I’ve had numerous conversations with US Manufacturers, Regulators and others about CFDA’s Innovative Device Pathway. And it’s clear there’s a real misunderstanding about the actual benefits and challenges this Pathway brings. In this article, I try to make it a little clearer on what leads to a successful application and most importantly, what that actually means.
Expedited? Perhaps Not.
So let’s start with the biggest myth. On numerous occasions, I’ve heard the Innovative Device Pathway also called the “Expedited” Pathway.
Wrong! Well, at least partially.
The Innovative path doesn’t necessarily always result in a faster approval process. Right at the beginning, it adds at least a couple of months in the pre-assessment and designation process. But as we will see, the process delivers something far more valuable – reduced regulatory risk.
The Innovative Pathway provides a supported application process from start to finish. This includes early engagement with the CFDA reviewers, pre-consultation meetings, and ongoing dialogue. You’ll have the classification process as part of the cycle, and priority with regard to type testing and FDA review (separately see our blog on China Draft Regulations for a review of the future of type testing).
It is also a common misunderstanding that the process to gain approval for the innovative pathway is simple and everyone can do it! Again, not quite accurate. The numbers of companies who have been accepted is very limited, and records suggest you have a better chance if you have a Chinese subsidiary.
Qualifying as Innovative Device
There are some essential criteria that must be met before you start.
- You must have a Chinese Patent lodged and listed. There are some simplified processes for quick processing of provisional patents in China which can be quick – but talk to an IP expert.
- You must have solid early stage research and data – done under reasonable design controls and a working prototype.
- Most important of all: the device needs to be truly different with a significant safety and performance advantage over existing products on the market.
There’s also one hurdle in China which is removed. Normally, CFDA will not accept an importer application unless the device is already approved in Country of manufacture. China is actively seeking to encourage innovators to come to China first and for qualified Innovative Devices this requirement is waived.
No free pass
It needs to be understood that the regulatory bar is not lowered via this pathway– you still go through the entire process – including a mandatory clinical trial (all new devices are expected to be qualified via in-China trial: after all, you are “Innovative”).CFDA may be relaxing on this point – with recent musings on acceptance of international data.
De-risking through dialogue
So what are the benefits of using the Device Innovative Pathway?
As anyone who’s done a CFDA device application knows, opportunities for dialogue and pre-consultation with CFDA are very limited. In most cases the only meaningful conversations are during the review process.
But for Innovative device manufacturers, that changes and the doors are open.
The real benefit of the process is a much higher quality of dialogue with the CFDA – throughout the entire process. CFDA appoints a lead reviewer responsible for shepherding your application through the entire process and making sure it doesn’t get lost in the bureaucracy. And as you move from desk to desk you go to the top of the in-tray.
CFDA will actively consult with the manufacturer on the design of clinical trial protocols and on the required test program. This level of dialogue is rarely available to lesser mortals going through conventional submission pathways. And it very substantially lowers risk, both for the applicant – who is more likely to produce a compliant submission with the integrated approach with the agency. And for the regulator. This level of dialogue means the regulator is managing the risk of dealing with something new and unknown – through a much deeper understanding gained by deeper dialogue.
The Innovative Device Pathway provides a great opportunity for manufacturers of innovative technology to find a lower risk way into the China market. But it’s essential to approach this fully prepared, to understand the process, and how it really delivers value and manage expectations within your own team.
In summary – the real benefit is active dialogue with the agency and active support to the entire review that steers things down the right track and avoids some of the headaches that often delay or completely derail complex applications to CFDA. It’s a bit like the old story of the turtle and the hare. Although you may not move more quickly, you are far less likely to get sidetracked or delayed.
And that can save a lot of time.
Want to know more about the Innovative Pathway in China? Be sure to reach out and speak with us! Better still, join us at the Asia Pacific Device Summit and hear directly from CFDA. Learn all about the Innovative Pathway from CFDA’s Yongheng Chang. Mr Chang is Executive Chairman of the CFDA’s China International Medical Device Regulatory Forum (CIMDR) – the world’s largest medical device regulatory conference, and past Deputy Director of CFDA’s China Center for Food and Drug International Exchange (CCFDIE). He will also provide an up to the minute update on CFDA regulatory changes. Want to talk now? Contact us here or email firstname.lastname@example.org