MFDS Improves Post-Market Safety Inspection Period for Medical Devices

The Ministry of Food and Drug Safety (MFDS) will simplify the procedure for extending the safety investigation period conducted after the marketing of newly developed rare medical devices and other medical devices.

The MFDS announced on the 18th that it has issued an administrative notice regarding the "Regulations on Post-Marketing Investigation of Medical Devices" (MFDS Notification) containing these details and will accept opinions until August 7.

Newly developed medical devices and rare medical devices must undergo investigations on their safety and efficacy within a period ranging from 4 to up to 7 years after the product is marketed. Until now, even extensions of the investigation period that did not require expert judgment had to go through a review by the Medical Device Deliberation Committee. Going forward, the procedure will be simplified to allow extensions of the investigation period without undergoing such a review.

Additionally, the current rule that uniformly sets the number of investigation cases to 600 or more regardless of the product’s indications and usage environment will be improved. From now on, the number can be determined by considering the characteristics of the product.

The MFDS expects that this revision will help secure cases for post-marketing safety and efficacy investigations, enhance the reliability of the system, and resolve inconveniences faced by the industry.

The MFDS will review opinions submitted during the administrative notice period and reflect them as necessary.

This content was produced with the assistance of AI translation services.