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Repair Business Registration

Entities that repair medical devices in Korea must register as a repair business (수리업) with MFDS.

Requirements​

  • Business registration in Korea
  • Qualified personnel capable of performing the repairs
  • Adequate tools, equipment, and facilities for the repair scope

Scope​

Required for repair activities on Grade II, III, and IV devices. Grade I may have lighter requirements.

Obligations​

  • Only repair devices within their qualified scope
  • Use genuine parts or approved alternatives
  • Keep repair records
  • Report adverse events discovered during repair

Scope Determination and Registration​

Repair business registration requires specifying the exact scope of repair activities. This includes:

  • Device grades and specific device types the business is qualified to repair
  • Types of repairs covered (e.g., mechanical adjustments, component replacement, software updates)
  • Geographical scope if applicable

The scope must be approved by MFDS during registration and can only be modified through a formal scope change application.