CFDA has recently published a news article summarising the meeting held for the ‘Reform of Medical Device Review and Approval Framework’ on the 18th Nov 2015.
In summary, more staff will be recruited to increase the capacity of CFDA, there will be more confidence in the innovative medical device pathway and an increase in harmonisation with international standards. Some low-risk medical devices will be further “down-classified” with a more scientific and dynamic classification system.
The framework also plans to integrate Class II and Class III registrations with the Class I filing online application platform.
There are seven main action items from the meeting, detailed as follows:
- Continue to implement the new regulations. CFDA will continue to increase training, improve the regulatory proficiency of staff and implement tighter measures to ensure adherence to regulations, such as strengthening on-site inspections and clinical trial site inspections.
- Continue to encourage medical device innovation. The innovative medical device pathway established by CFDA functions well and an innovation-driven product development has been initiated. To improve the working mechanisms, the expert team will be further developed to closely track the forefront of technology and improve the capability of review and approval.
- Improve the quality standard of medical devices. There will be more timely review of medical device standards, as well as more coverage and harmonisation with international medical device standards. The focus will be to monitor and recognise the latest international standards, revise regulations related to product supervision, revise standards related to product safety and improve the science and applicability of the standards.
- Continue to improve the classification of medical devices. This includes improving the classification of medical devices, adjusting the approval body (CFDA/Provisional CFDA) and responsibilities of medical devices that are mature and safe, speeding up the construction of Classification Technical Committee, reforming the workflow of device classification to achieve scientific classification and establishing a dynamic adjustment mechanism to the classification system to support the regulation of medical devices.
- Comprehensively improve the quality of review and approval. Reform of the medical device review model will involve gradually changing the single-reviewer based model, standardising the appeal process for registration application, optimising the review and approval process and continuing to strengthen the verification of clinical trial data.
- Improve the transparency of review and approval. This involves timely publishing of the list of medical devices and the legal basis for review. The approval requirements and processing timelines will outline the progress and result of the review to the applicant. CFDA will continue to construct the medical device registration online system which will centralise the applications onto an online platform. It is written in all relevant post-2014 regulations that CFDA will publish the Performance Index/Requirement section of Product Technical Requirement (PTR) of all the medical devices registered. However, it is yet to be known when this will be implemented.
- Strengthen post-market surveillance of medical devices by implementing an all-round regulation from the laboratory to the hospital. There will be an increase in unannounced inspections for production and distribution. Enterprises will be urged to earnestly fulfil their main responsibility and strictly implement the relevant quality management standards to ensure the quality and safety of medical devices.
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