On the last day of October China’s CFDA published an exposure draft update to Order 650 – the primary medical devices regulation. The draft contains a number of far reaching proposals which if implemented promise substantial improvements in the regulatory process. The draft is a lengthy document (and of course it’s in Mandarin). But here are the highlights:
Agent and Postmarket Responsibilities Clarified
There are a range of proposed changes to simplify and clarify roles of local agents and international manufacturers with regard to postmarket activities. In particular
- Chinese agents acting on behalf of overseas manufacturers will be required to have quality systems covering postmarket risk management and control, and will be required to hold liability insurance.
- Obligations of agents are defined to include:
- acting as liaison between CFDA and applicant for timely communication of regulatory matters including postmarket reporting including adverse events and recalls and assisting in arrangement of CFDA inspections.
- legal liability for the violation of the product quality and related services.
Clinical Trials – Faster Approvals for High Risk Devices and Acceptance of International Data
It’s currently necessary to have CFDA approval for clinical trials of high risk devices. This is similar to high risk IDE approvals in the USA and Competent Authority review of protocols in Europe. Review delays can be troublesome and impede the start of trials. Under proposed new arrangements, there will be a hard 60 day deadline for CFDA review, and if the CFDA doesn’t respond within that time, the trial is deemed to be automatically approved.
The new regulations also propose direct acceptance of international data. however it remains to be seen what caveats will be placed around that (see our earlier blog on this subject)
Streamlining CFDA Reviews – Fewer Unique Chinese Requirements
One of the frustrations of operating in China is the number of special local requirements which add time and red tape. Some of these are being cleared away:
- Manufacturers of Innovative medical devices will no longer need to provide proof of sales abroad – opening the door to China first approvals.
- Abolition of Type testing requirements for Class II and III device submissions – replacing this with international testing reports/certificates from accredited laboratories.
- Renewal submissions will be focus onreview of postmarket data. Manufacturers beware: If you don’t have adequate monitoring and reporting systems in place, then renewals may be denied.
A Bigger Stick for Postmarket Supervision
While premarket is being streamlined, there is strengthening of postmarket supervision.
- Sale of used medical devices will be forbidden.
- CFDA postmarket team will be strengthened.
- Punishment for postmarket offences will be enforced to individual responsibility – e.g. legal representative, top management etc.
Chinese Names for Applicants
Finally there are some administrate requirements for addition of a Chinese name to all filings and update of this information on current registrations and licenses by end of 2018.
Happy New Year?
Once again China has looked to the international practices and chosen to weave some of the best into its own systems.
The abolition of Type Testing will be particularly welcomed, as will the expedited approval of high risk clinical trials and greater acceptance of international clinical data.
CFDA has a recent track record of acting very quickly on regulatory updates. This exposure draft consultation closes at end of November. This could all become law by February. Here’s to a Happy (Chinese) New year!
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