엠디웍스코리아

Quality Assurance

Re-evolution and Post-market Surveillance of Medical Device

Re-evolution overview

Re-evolution

Since it is impossible to obtain all the information on the safety and efficacy of newly developed medical devices and rare medical devices with only limited data at the time of approval, the aim is to efficiently manage the safety and efficacy by investigating and confirming factors affecting them for a wide range of patients after approval and then reflecting them in the approval matters.

Regulation & Guidance

Medical Device Act

Enforcement Rule of Medical Device Act

Re-evolution Regulation of Medical Device

Subject

Subject to Re-evolution

Among medical devices with a manufacturing (import) license or notification, devices for which the Commissioner of the Ministry of Food and Drug Safety (MFDS) determines that safety and effectiveness should be reassessed.

Exclusions

① Devices within a re-examination period
② Devices withdrawn or cancelled during the Re-evolution period
③ Devices licensed or notified solely for export

Process

STEP 01

Selection and notice of Re-evolution subjects

From 1 to 3 years before the Re-evolution application date

STEP 02

Determination and public notice of Re-evolution products

STEP 03

Re-evolution application

Within the Re-evolution application period

STEP 04

Conduct of Re-evolution and draft preparation

STEP 05

Public inspection

One month from the date of public notice

STEP 06

Submission of comments

STEP 07

Finalization and public notice of Re-evolution results

According to the schedule announced by the MFDS after review

STEP 08

Follow-up measures

Within 1–2 months from the date of public notice

Re-examination (post-market surveillance) overview

Purpose

Because not all safety and effectiveness information for innovative or rare medical devices can be obtained from limited data at the time of approval, factors affecting safety and effectiveness are investigated and verified in a broad patient population after approval and reflected in the approved labeling to enable efficient management.

Legal basis

Medical Devices Act

Enforcement Rules of the Medical Devices Act

Regulations on Post-Market Surveillance of Medical Devices

Subjects and procedure

Products subject to post-market surveillance

Products classified as innovative or rare medical devices for which the Commissioner of the MFDS determines that post-market surveillance of safety and effectiveness is necessary.