Imported/Manufactured Product (Approval, Certification, Notification)

Medical Device Renewal System: What is the medical device renewal system?

According to the revision of the Medical Device Act (enforced in October 2020), medical device manufacturers and importers must extend the expiration date to continue manufacturing and importing the product even after the expiration of the expiration date specified for each product.

Basis of law: Article 49 (Renewal of Manufacturing Permit, etc.) of the Medical Device Act and Article 62-2 of the Enforcement Rules of the same Act (Renewal of Manufacturing Permit, etc.), “Regulations on Renewal of Manufacturing Permit, etc. of Medical Devices” (Notice)

Application period: Between 270 and 180 days before the expiration of the manufacturing license, etc.

Submission Documents

Submission Documents	1st cycle ('25~'29)			Dealer			Note (Maintenance)
Submission Documents	Declaration	Certification Approval	Suspension of production and import	Declaration	Certification Approval	Suspension of production and import	Note (Maintenance)
1) Application form	○	○	○	○	○	○
1) Application form	○	○	○	○	○	○	○
2) Original permit (certificate)	x	○	○	x	○	○	○
3) List of submitted Documents (Form No. 1 attached)	○	○	○	○	○	○	○
4) Data reflected the latest standards (Form No. 2 attached)	x	○	x	x	○	x	x
5) Test report or evaluation data (or Declaration of Conformity (DoC))	x	x	x	○	○	○	x
6) Data on about production and import performance	○	○	○	○	○	○	○
7) Data on Safety information and measures	○	○	○	○	○	○	○
Notified products or medical devices subject to production/import suspension reporting