Speaking at the 6th International Medical Devices Regulatory Forum (CIMDR) in Guangzhou on 24 September, and CFDA’s Director of the Department of Medical Device Registration Wang Zhexiong set out the agency’s agenda for reform.
The agency faces a big task in modernising. It is still in the early stages of implementation of the 2014 regulatory update. Scarcely a day goes by without publication of a new guidance or roll out of a new order or update.
So what are the priorities for CFDA? Director Wang focussed on five key areas:
- Managing workload by streamlining lower risk devices and focusing on high risk. at the end of 2014 the agency had some 85,171 valid registrations on its books, and that number is growing rapidly. Of those more than 20% are imported. The agency plans back office changes to optimise evaluation and approval processes. Those familiar with the intricacies of working with CFDA will be familiar with some of the recent changes including updates of workflow management software for Class II registrations and electronic filing arrangements for Class I devices.
- Updating technical guidances and standards. CFDA continues to update guidances at a fast pace. Examples being recent updates on classification, software and clinical trials. An area where China has lagged behind is in standards, with use of superseded versions of core Technical standards being a constant cause of confusion. A particularly notorious example being China’s use of superseded versions of IEC 60601 and other electrical safety standards which creates unnecessary duplication of testing requirements for imported devices. To fix this Director Wang announced plans for substantial program of revision and update of existing standards and formulation of new standards. 500 separate standards are planned to be reviewed and updated over the next 5 years.
- Further Adjustments in Classification are to be expected, as CFDA continues to fine tune the classification rules and expand its classification catalogue.
- Encouragement of Innovation through the Innovative Device Program. The program is proving surprisingly popular including with international firms : 236 applications have been received and reviewed to date and of those 38 have been granted innovator status. Ten of these are currently under review and eight more have already been approved. There was much emphasis on the approach to innovative devices being all about support to the applicant, efficiency of process but with no loss of rigour in review standards and requirements. The CFDA’s process effectively appoints an internal champion and provides for a careful management of the submission to ensure it is dealt with as quickly as possible, but using exactly the same regulations and requirements as applied to all devices.
- Increased Transparency of Process. The increasing computerisation of the registration workflow is intended to make it simpler for the agency to track and monitor progress of submissions, and to provide feedback to applicants of the status of their submissions. The new project management arrangements are to include time limits and stricter process controls. Director Wang promised greater clarity of the legal basis for and reasons behind individual decision making.
The ongoing regulatory reform in China is ambitious and far reaching. China is very much wanting to be seen as implementing the best practices from around the world and continues to borrow freely from international practices, picking and choosing different elements and stitching them together in ways that are uniquely Chinese. The classification rules are closely based on the GHTF model, but arte used by the agency to compile a device catalogue that looks much like the classification regulations in the FDAs regulations. Clinical evaluation requirements have toughened up on requirements for local trials, but also allow a literature and predicate based alternative which borrows heavily from the substantial equivalence determination that underlies the US FDA’s 510k review.
It’s clear that anyone doing business in China can expect much more of the same – continuing the frenetic pace of updates and adjustments to specific technical regulations coupled with big picture changes in regulatory infrastructure and process.
Useful Links (all with English language translations):
Need help in China? With our multilingual expert advisers and wholly owned in China offices and operations, we can support your regulatory submissions and compliance in China. Contact us today to discuss your specific needs and how we can help.