Revision of MFDS Notification
[Asia Economy Reporter Lee Gwan-ju] The period for companies to submit materials during the second supplementary review in the medical device clinical trial plan approval process will be extended to 30 days.
The Ministry of Food and Drug Safety (MFDS) announced on the 14th that it has revised the "Regulations on Approval of Medical Device Clinical Trial Plans" to include this change.
During the review process for approval of medical device clinical trial plans, the MFDS may request companies to supplement submitted materials twice if necessary. Previously, the submission periods were set at 30 days for the first request and 10 days for the second. With this revision, the submission period for the second supplementary materials has been extended to 30 days.
An MFDS official explained, "Clinical trials are the stage where the safety and effectiveness of medical devices are verified on humans. We actively reflected opinions from industry and academia that it is difficult to submit supplementary materials within 10 days due to the large amount of materials that need to be reviewed when supplementary requests are made."
Additionally, the revised notice specifies reasons for which the MFDS may extend the processing period during the review of clinical trial plan approvals (including changes) when more time is needed. Specifically, these include ▲ the need for consultation with the Medical Device Committee ▲ the need for external expert opinions for new or innovative medical devices ▲ changes in major clinical trial details such as the principle or intended use of the medical device in the clinical trial plan.
The MFDS stated, "We will continue to do our best to establish and implement a balanced medical device safety management system that prioritizes the protection of clinical trial subjects while supporting industrial development in the operation of the medical device clinical trial plan approval system."
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