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

Related pages

• Distributor and retail dealer registration

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.