The Ministery of Food and Drug Safety on the 3rd gave advance notice of legislation for a revision to the Enforcement Rule of the Medical Devices Act that includes introducing a "negative list" system under which companies autonomously change and manage matters except for major changes. This revision is part of the "50 tasks for safe food and drugs."
The main points of the revision are: ▲ introduction of a negative list system for medical device change approvals ▲ shortening the period for verifying compliance with conditional approval matters ▲ establishing a procedure for ex officio cancellation of medical device sales and rental business registrations ▲ clarifying medical device recall criteria ▲ revising the authority to disclose foreign substance investigation results.
First, the system will be overhauled so that prior change approval is required only when a change in a medical device has a significant impact on safety and effectiveness. This applies to changes such as address (addition), intended use, mechanism of action, and materials and supplies.
Accordingly, companies must establish and submit change self-assessment and management procedures at the time of initial approval application, and thereafter record and manage changes in accordance with those procedures. The Ministery of Food and Drug Safety said it would overhaul the change management system to expand corporate autonomy while strengthening accountability.
If a manufacturer or manufacturing license is granted on the condition that Good Manufacturing Practice (GMP) is put in place within a certain period, the processing period to confirm whether the condition has been fulfilled will also be shortened from the current 20 days to 10 days. The explanation is that corporations' production preparations and product launch schedules will run more smoothly.
In addition, pursuant to the revision of the Medical Devices Act (effective Feb. 6, 2024), which allows ex officio cancellation of sales and rental business registrations when a business closure is reported to the tax office or a business registration is canceled, specific procedures will be newly established in subordinate regulations. Before an ex officio cancellation, the relevant operator will be given prior notice, and the planned cancellation will be announced on the competent authority's website for at least 10 days.
The recall criteria were also clarified to include cases that do not meet not only the standard specifications but also the approved test specifications during the process of collecting and testing distributed products. The Ministery of Food and Drug Safety explained this as a measure to resolve inconsistencies between the law, which currently specifies only nonconformity with standard specifications as subject to recall, and field operations.
When a foreign substance is found in a medical device, the authority to disclose investigation results and other information has been delegated to the heads of the regional food and drug administrations through an enforcement decree revision (Feb. 9, 2025). Accordingly, the enforcement rule will also be adjusted to align the publishing body with the investigating body.
Kim Young-min, president of the Korea Medical Devices Industry Association, said, "With this system improvement, medical devices that reflect the needs of clinical settings can be supplied quickly, and we expect the time required for change procedures to be shortened," adding, "The industry will also create an environment that the public can trust through a responsible self-management system."