Distributor and Retail Dealer Registration
Entities distributing medical devices in Korea must register with MFDS before commencing distribution. Registration is mandatory even if the distributor is also the product's approval holder (품목허가/신고 holder).
Who must register?
- Distributors (판매업자) — selling devices to healthcare facilities or other distributors
- Rental dealers (임대업자) — renting medical devices to users
Registration requirements
- Business registration in Korea
- Designated compliance responsible person
- Adequate storage facilities (temperature control etc. as applicable)
Ongoing obligations
- Only supply devices with valid 품목허가 / 품목신고
- Maintain storage conditions per manufacturer requirements
- Keep distribution records for traceability
- Report adverse events they become aware of