China regulatory submissions are notoriously challenging. All too often, the root cause is a misunderstanding of the regulators expectations and interpretation of the requirements. In an attempt to reach a common understanding, the CFDA’s Centre of Medical Device Evaluation (CMDE) recently hosted over 400 industry professionals and CMDE reviewers in Beijing for a 3 days intense training on In Vitro Diagnostics regulation. Members of the Brandwood Biomedical Beijing team were there. We take a look at the outcomes.
Discussion was wide ranging including:
- Submission dossier requirements for IVD and instruments
- A review of the frequently asked questions which are collected in the technical review cycle
- Requirements around Clinical trials and developments of the clinical trial protocols
- Specific requirement for the Chinese Instructions For Use (IFU)
- Development of the Product Technical Requirement (PTR)
- Administrative changes and partition of the registration unit
Resource pressures at CMDE
Over 300 review projects are considered each year. With this level of incoming applications, there is a growing need for CMDE to continue hiring reviewers. However, not unlike other regulators, this level of growth requires a substantial investment by CMDE in bringing the new hires up to speed. It takes time and although reviewer recruitment is proceeding, it’s going to take some time before the staffing increase will impact backlog and review times start to reduce.
Biggest delays are in new registrations and change notifications
There was discussion around the current timelines for both new product registrations, change registration and license extensions. It appears that the majority of delays are seen within the new registrations and change notification areas.
In contrast, license renewals and extensions are meeting the timelines. The statistics suggest that the CFDA are targeting license extension, where products already on the market are less likely to be to be impacted.
IVD Clinical exemptions in the works
A particular challenge in China is the requirements for clinical studies for all Class II and III IVDs. CFDA is currently reviewing a clinical exemption list for IVD products, like that already in place for Medical Devices. The publication of the exemption list could see a dramatic reduction in the number of IVDs that require clinical trials in China. As there appears to be a growing demand on both CROs and Hospitals, this can only be considered a good thing once released. CMDE was unable to provide a timeline for publication of the list – watch this space!
Collaborative training – common understanding
This collaborative approach – involving both industry professionals and CMDE reviewers in the same training sessions helps to build a common understanding of requirements, processes and expectations. Joint training sessions will help align the expectations, assist the regulator in receiving the correct information the first time, and drive the review timelines down delivering better outcomes for industry.
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