엠디웍스코리아

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Licensing

Medical Device Listing Renewal

Guide to renewal of medical device manufacturing approval

Purpose of the system

To periodically reassess safety and effectiveness after initial approval, certification, or notification, and to maintain efficient medical device management by clearing items no longer manufactured or imported, medical device renewal is carried out every five years.

Legal basis

Medical Devices Act and Enforcement Rules of the same Act

Regulations on Renewal of Medical Device Manufacturing Approvals, etc.

Medical device renewal overview

Who must renew

All classes of medical devices that have been approved, certified, or notified. Excludes medical devices manufactured or imported solely for export, and devices under conditional approval, certification, or notification.

Application deadline

Apply between 270 and 180 days before the manufacturing approval (etc.) expires.

Renewal criteria
  • No serious issues with the safety or effectiveness of the device
  • Materials required for renewal of the manufacturing approval are submitted in good faith
  • There is a record of manufacture or import of the device
  • Applicable medical device laws and regulations have been complied with in good faith
  • Other criteria similar to the above that meet standards prescribed and publicly notified by the Commissioner of the Ministry of Food and Drug Safety

Required documents

Documents to submit 1st cycle (25–29) 2nd cycle (30–40) Notes (life-cycle maintenance)
Notification Approval · Certification Manufacture/import discontinued Notification Approval · Certification Manufacture/import discontinued
Application form ◯ ◯ ◯ ◯ ◯ ◯ ◯
Original license (certificate) ◯ ◯ ◯ ◯ ◯ ◯ ◯
Submission checklist (Form 1) ◯ ◯ ◯ ◯ ◯ ◯ ◯
Materials reflecting the latest standards (Form 2) X ◯ X X ◯ X ◯
Test reports or evaluation materials - X - - X - ◯
Declaration of Conformity (DoC) ◯ ◯ ◯ ◯ ◯ ◯ ◯
Materials on manufacture/import performance ◯ ◯ ◯ ◯ ◯ ◯ ◯
Materials on safety information and corrective actions ◯ ◯ ◯ ◯ ◯ ◯ ◯

Renewal procedure

1

Obtain approval (certification, notification)

After medical device approval, certification, or notification is completed, a five-year validity period applies. You must apply for renewal before the validity period expires.

If renewal is not applied for: approval (certification, notification) ceases to be effective after the validity period ends.

2

Renewal application

You must apply for renewal between 270 and 180 days before the validity end date.

Attachments

  • Original approval (certification) certificate
  • Evidence maintaining safety and effectiveness (test reports reflecting the latest standards, evaluation materials / notified products: Declaration of Conformity)
  • Manufacture/import performance records
  • Safety information and corrective-action materials
3

Document review

After document review is completed, you will be notified of a conforming or non-conforming determination. (Processing period: up to 180 days)

Reissuance Conforming

A new validity period is granted and the approval (certification) certificate is reissued.

Renewal criteria not met Non-conforming

Includes failure to submit supplementary materials.

Failure to meet renewal criteria and loss of effect

Approval (certification, notification) ceases to be effective if any of the following applies.

  • Serious safety or effectiveness issues
  • Non-compliance with applicable laws and regulations
  • Renewal materials not submitted in good faith
  • Product subject to distribution ban due to re-evaluation results, adverse events, etc.
  • Use of raw materials subject to approval restrictions
  • No manufacture or import performance