The China International Medical Device Regulatory Forum has to be the world’s largest single Medical Device regulatory conference. This year the conference was held in Hangzhou, in a conference center originally purpose built for the G20 summit. The main auditorium seated close to 2,000, and it was standing room only for the opening plenary. In addition the conference program included almost 20 specialist workshops on topics as diverse as biocompatibility and cybersecurity.
There were international updates from FDA, Europe, Japan and many other regulators. Most important of all CIMDR is the setting for detailed annual updates from Vice Minister Jiao Hong and the CFDA leadership on the agency’s reform Agenda in a series of keenly observed set-piece speeches.
So what did we learn this year?
Well CFDA continues to advance the reforms of the medical device regulations, with developments on a number of fronts, in device classification, the whole clinical trials and clinical evidence framework and around the fundamental approach to Type Testing. The agency also continues to improve its back office – with substantial increases in reviewer hiring and streamlining of processes. The agency is also beefing up its postmarket and compliance activities, especially in the area of clinical trials – with a series of audits uncovering significant issues with data integortiy in current trials – to the cost of the sponsors.
Reviews – higher workloads – better processes
The CFDA workload as measured by registration filings continues to increase. Registrations grew 15% in 2016 from 7,530 to 8,653. The half year 2017 numbers (5,143 registrations) point to another 18% rise this year. At this rate of growth, the agency has to find ways of becoming more efficient and raising productivity. And there’s work going on to improve the review processes on three fronts:
- Teamwork: CFDA has introduced group reviews pulling together expert teams to work on a review rather than a single reviewer. This is backed up by a new project management system to support the team approach.
- Guidance: New Review guidance/standards have been developed to build a clearer framework around review conduct. These include:
- Good Review Practice for Medical Devices
- Administration Measures for Technical Review Expert Advisory Committee
- Administration Measures for Medical Device Communication
- Reviewer Development CFDA is certainly hiring many new reviewers. And along with that is implementing an enhanced induction and training program. It’s a very hot market for regulatory professionals in China right now, and CFDA has recognised this and improved reviewer pay. It certainly seems to be working: In a training course in biocompatibility evaluation delivered the day before CIMDR, we were astonished to be joined by more than 100 new reviewers in the audience.
In addition, CFDA is further streamlining process by phasing in direct approval of device reviews by the Center for Medical Device Evaluation. This eliminates the current final step where all reviews are referred back to CFDA headquarters for final CFDA administrative assessment and issue of certificates. This should lop 10-20 days from the review cycle.
CFDA is also exploring longer term options for improving both speed and rigour of reviews including greater integration with IMDRF and participation in international information sharing and harmonisation activities.
The CFDA priority review pathway announced last year is now underway. The priority areas are broadly defined – medial devices addressing rare diseases, or for applications in paediatrics, geriatrics or oncology. Also devices which are developed as part of Chinese National National Key Research and Development Program. So far only 6 applications have entered priority review, and five of those are national R&D projects. So it remains to be seen how effective the priority review path will become.
Device Classification – major overhaul in the works
CFDA regulations include a set of classification rules. But in a very Chinese way, these are not applied directly by the manufacturer but are instead used by CFDA to derive an extensive catalogue of device classifications. The CFDA is currently undertaking an extensive review of the classification catalogue. This will result in:
- the current 43 directories being reduced to 22 directories
- 260 product categories being reorganised into a two tiered system of 206 Level I, and 1157 Level II product categories
- More than 2,000 additional product descriptions and intended purposes
- An increase in product names from the current 1,008 to more than 6,000.
As a result of this review, some 40 categories covering at least 424 existing registrations will be down classified. A further 206 categories covering 1,260 current certificates will be up classified. It’s not clear yet what transitional arrangements will apply but the most likely approach will be to apply the new classifications at next license renewal.
This is clearly a major undertaking and it’s set for launch on 1 August 2018. Keep a lookout for announcements a little less than a year from now.
Technical Standards and Guidance
At the 2015 CIMDR, CFDA announced a plan to implement 500 new standards in 5 years, and it looks as though they are well in advance of that plan. Statistics presented this year indicated a total of 190 new and 60 revised standards published in 2016 alone.
CFDA has also been very busy writing its own guidances, and is not neglecting the hot topics:
- 48 guidelines were issued in 2016
- 35 guidelines were issued and implemented in 2017, including “Cybersecurity Technical Review of Medical Device Registration”
- >180 guidelines have been issued so far
- 200 guidelines will be established/revised during 2016-2000
CFDA has continued to widen the exemptions from clinical trials with now more than 1,000 devices and IVDs eligible for exemptions and CFDA contemplating return to acceptance of foreign clinical data. CFDA has also been talking about stepping up supervision of clinical trials and presentations at CIMDR gave some insight into the progress of that supervision. In 2016 CFDA conducted 20 random audits of clinical trails for data authenticity and compliance with a further 10 audits completed so far this year. Issues that have arisen with data authenticity included:
- Testing data traceability
- Specimen traceability
- Re-use of specimens or use of duplicate samples from same patients
- Discrepancies from data submitted in regulatory filings to the data archived at the clinical trial sites.
Clinical trial management and review is being streamlined. CFDA is dispensing with accreditation of clinical trial sites and instead moving to a notificiation system where sites must declare compliance with a set of objective criteria as to the experience of investigatiors and capacity to conduct trials. This should broaden the number of facilities available for trials.
Type testing was not prominent in any of the CFDA presentations, but it was an active discussion on the sidelines. The recent withdrawal of type testing fees, coupled with no replacement central funding of laboratories has caused substantial (hopefully short-term) disruptions to type testing activities. See this separate blog reviewing a possible major overhaul of type testing.
So in summary, China continues to make substantial changes in regulatory requirements and infrastructure in what is a very broad reaching modernisation of its regulations. And there’s no sign of a slow down. Change is the new normal in China, and constant vigilance is required to keep on top of it all.
Seeking China market access? With offices in Beijing and a team of bilingual experts in both our Sydney and China offices, we can support your CFDA regulatory filings. Contact us today about clinical evaluation in China, Type testing or CFDA submissions. Email email@example.com or call +61 2 9906 2984