Registration
Re-evaluation and Post-marketing Surveillance (Re-examination)
Re-evaluation and marketing post-investigation
What is Re-evaluation?
If re-examination of safety effectiveness is required due to post-marketing information among approved/certified/notified medical devices, designate and implement target items.
What is Post-marketing surveillance?
Newly developed medical devices, rare medical devices, etc. do not have enough use cases for side effects at the time of the approval, so 'post-marketing surveillance' is conducted for a certain period of time (4 to 7 years), and safety and effectiveness are re-verified through analysis of the results.
Selection of target items
Selected as a product target by the Minister of Food and Drug Safety(MFDS)
Product notice
Example: 1 year prior to application for re-evaluation
Apply for Re-evaluation
Complete and submit re-evaluation submission documents
Re-evaluation Notice
Announcement of re-evaluation results for the relevant item after submission of opinion
Follow up
Measure regarding re-evaluation results, etc.
Review the results
View draft results of re-evaluation
Post-marketing Surveillance (Re-examination)
| Ministry of Food and Drug Safety (MFDS) | Company (Manufacturing and Import) |
||
|---|---|---|---|
| Stage designation | Designation of re-examination target(Review Department) | Setting the re-examination period (4-7 years) | |
| Submit plan | Preparation of post-marketing surveillance plan | Submit to the department no later than January before market date *Consideration of prior review before approval | |
| Plan Review | Post-marketing surveillance plan (Review/Supplementary Notification Review Department Management Department) | Post-marketing surveillance plan (Supplementary / implementation) | After reviewing the investigation agency, number of cases, investigation period, and investigation method (Medical Device Committee), whether to supplement or not is decided. |
| Conduct post-marketing surveillance | Conduct post-marketing surveillance | Conduct post-marketing surveillance according to the post-marketing protocol (1 year after marketing, 2 months after completion) | |
| Conduct post-marketing surveillance | Reliability Investigation Review Department Management Department | Post-marketing surveillance annual report | The company conducts a post-marketing investigation according to the post-marketing plan and conducts a joint investigation between the marketing department and the management department (reliability) |
| Application for re-examination | Reliability Investigation Review Department Management Departmen Deliberation and result notification management Department | Final result report Application for re-examination | Medical device committee review within 6 months of application for re-examination Notification of results after (final judgment of stability and efficacy) |
| Follow-up | Action taken notification management department | Actions based on re-examination results | Take action such as permission for change |