But, of course, it’s not the end of the story. Regulation is whole-of-product-life and postmarket monitoring matters.
Postmarket regulation is on the rise everywhere – as a counterbalance to the imperfections of premarket assessment. Designers and reviewers are human and sometimes get it wrong. In the laboratory of the real world, it’s important that someone’s keeping a close eye on the latest results. So, we have postmarket surveillance, active monitoring of field performance and customer feedback, corrective action systems, updating of risk assessments, adverse event reporting and when necessary, field corrections and recalls.
All this is especially true in China, where the latest changes in CFDA regulations mean renewals are now all about looking back at the postmarket record. If you haven’t paid attention to postmarket, expect to struggle with registration renewal.
CFDA Renewals focus on postmarket compliance
The latest round of proposed regulatory changes in China promises to bring things full circle, making evidence of effective postmarket systems the primary determinant of a successful premarket registration renewal.
In China, it’s necessary to renew registrations every 5 years. It used to be an onerous process, requiring a complete repeat of the registration including type testing. The 2014 revision of Order 650 did away with much of that, instead shifting focus to the postmarket record for devices where there were no significant changes to design. The renewal typically involves scrutiny of postmarket records, including questions about the systems used and their effectiveness. Our direct experience in China has been that if manufacturers have not been diligent in postmarket monitoring, they get a very tough time in renewal submissions and rejections do happen – with calamitous results.
A new inspectorate, with a liking for international travel
On October 30th, 2017, CFDA published a new round of proposed revisions to Order 650 (see links below). The agency is now pushing further into monitoring of manufacturers and suppliers.
The CFDA is now planning the establishment of a much expanded professional inspectorate. FDAs at City and Provincial Level (yes there are many FDA’s in China – not just the national CFDA) will set up specialised institutions with specialised personnel to undertake inspection of manufacturers and those inspections will include postmarket systems. And the system will work so that the higher level FDA’s, including the national CFDA, will direct the systems and activities of the new inspectorates. This even includes things like inspector performance review, remuneration, promotion and other incentive and restraint mechanisms. CFDA is getting serious about its capacity to do postmarket manufacturing inspections.
All this is principally about improving the compliance of the domestic industry as part of a broader and longer-term initiative in transforming the domestic industry from a predominantly me-too or contract manufacture sector to one based on local innovation. But it’s not just about the locals. CFDA has signalled its intent to conduct more international audits and has begun doing so.
Clinical trail audits
This enthusiasm for inspection is also extending to clinical trials – with several recent announcements from CFDA contemplating more acceptance of international data – but also more direct audits of international trials by CFDA.
All of this is part of a broader push, driven by requirements set out in the 2015 State Council to streamline administration while at the same time strengthening regulation. The aim is a smoother process but more effective control.
Regulatory Action may be the least of your worries…
CFDA is getting serious about penalties too. The proposed revisions introduce new and quite explicit responsibilities for managers with new clauses added to the regulation to specify the punishment on responsible persons. Responsible persons include legal representatives, principal persons in charge of compliance and manufacturer and anyone who had responsibility for illegal activities around medical device registration, filing, manufacture and supply. Penalties start at 30%-100% of last year’s income…
Considering entry to the China market? Our bilingual experts can support your China compliance needs. We support strategy, Testing, Clinical Trials, CFDA submissions, postmarket compliance and reimbursement. We are experienced at preparation of technical reports including biocompatibility and Clinical Evaluation reports to support CFDA filings. Contact us for a free, no obligation discussion. Email firstname.lastname@example.org or call +61 2 9906 298