Medical Device Approval in Korea.

Responsibilities

• Since 31 August 2020, the MFDS division responsible for advanced product authorisation has handled medical device manufacturing/import approvals under Articles 6 and 15 of the Medical Devices Act and Articles 4, 5 and 30 of its Enforcement Rule.
• Key Functions
  • Approval and change approval for Class 3 and 4 medical devices
  • Approval and change approval for Class 1 and 2 devices subject to the approval pathway
  • Reissue of manufacturing/import product licences
  • Issue of English certificates for manufacturing/import product licences

Devices Subject to Approval

• Articles 6 of the Medical Devices Act and 4 of its Enforcement Rule place Class 3 and 4 devices under the approval pathway. Class 1 and 2 devices also require approval where they are not substantially equivalent in structure, principle, performance, intended use or method of use to devices already approved, certified or notified.
• The applicable guidance on delegated certification/notification and designated technical review bodies identifies the following Class 1 and 2 categories as requiring approval.
  • 1. Devices combined with medicinal products or quasi-drugs
  • 2. U-healthcare devices
  • 3. Continuously worn respiratory monitors subject to tracking requirements
  • 4. Daily-wear rigid and soft contact lenses that may have biological effects through continued use
  • 5. Devices under the integrated device approval and new health technology assessment procedure
  • 6. Devices lacking substantial equivalence or requiring clinical trial data
  • 7. Devices without a notified subcategory

Approval Procedure