Under the Pharmaceutical Affairs Act, new drugs operate under an approval-patent linkage system, while medical devices do not have such a system in place according to current regulations, meaning that no special advantages are granted for novel medical devices first to be approved on the market. For reference, the approval-patent linkage system under the Pharmaceutical Affairs Act requires that when a new drug is approved, the patent holder registers patent information (e.g., ingredients, composition, usage, etc.) with the Ministry of Food and Drug Safety (MFDS). If a generic drug applies for approval during the patent's duration, the MFDS is required to notify the patent holder of the application. Additionally, if the MFDS determines that there is a concern of patent infringement, the approval process for the generic drug may be temporarily suspended for a certain period (approximately 9 months). During this period, the patent holder may file a patent infringement lawsuit to receive a court judgment, which will determine whether the generic drug can be approved.
According to the recently announced MFDS Regulations for Approval, Certification, Notification, Review, and Evaluation of Digital Medical Products (pre-announcement of administration), the substantial equivalence (SE) system is being abolished for medical software incorporating digital technology, which means clinical trial data must be submitted as a requirement for approval of follow-up products. In contrast, the regulation stipulates that the current SE system will be maintained for digital medical devices with built-in software (=hardware), but it limits the subject of equivalence comparison. According to these regulations, "digital medical devices that have been approved/certified based on evaluation materials such as clinical trials cannot be selected as SE comparators for up to 3 years after obtaining the approval/certification."
This regulation is similar to the approval-patent linkage system for drugs in that it restricts SE comparisons for new digital medical devices and is therefore seen as a system designed to allow for market exclusivity for a certain period. Therefore, it is important to fully consider these regulations when planning market entry strategies. For reference, this system is currently under public review, so it is important to continuously monitor whether it will be adopted as is.
