November 19, 2024

The Ministry of Food and Drug Safety (hereinafter "MFDS") has recently issued administrative pre-announcements of amendments to the 'Regulations on Approval, Notification, Review, etc. of In Vitro Diagnostic Medical Devices' and the 'Regulations on Medical Device Labeling Requirements'.

The main purposes of these amendments are to expand the scope of clinical performance data accepted during the approval/review process for in vitro diagnostic medical devices in situations where it is difficult to obtain specimens, as well as to make reasonable improvements to the method of displaying the addresses of overseas manufacturers on medical device labels. The details are as follows.

In cases where there are limited occurrences of the target disease, making it difficult to obtain clinical performance data from actual specimens, and where the intended use of the device demonstrates special utility, clinical performance data obtained using artificial specimens will be accepted for approval. However, the clinical trial protocol must also be submitted to demonstrate that the sufficient sample size of the test subjects have been recruited in the order of actual specimens, residual specimens, and artificial specimens.

2. Revision of the Method for Displaying Manufacturer's Address on the "Label"(Article 6 of the Regulations on Medical Device Labeling Requirements)

Please consider these updates when developing your medical device approval and distribution strategies. As a specialized consulting firm in the medical device field, MDREX promptly identifies domestic medical device regulations and supports manufacturers and importers in regulatory compliance. For assistance with medical device regulations and market entry, please contact MDREX at pro@mdrex.co.kr