Distributor and Retail Dealer Registration
Entities distributing medical devices in Korea must register with MFDS before commencing distribution.
Who must register?โ
- Distributors (ํ๋งค์ ์) โ selling devices to healthcare facilities or other distributors
- Rental dealers (์๋์ ์) โ renting medical devices to users
Registration requirementsโ
- Business registration in Korea
- Designated compliance responsible person
- Adequate storage facilities (temperature control etc. as applicable)
Ongoing obligationsโ
- Only supply devices with valid ํ๋ชฉํ๊ฐ / ํ๋ชฉ์ ๊ณ
- Maintain storage conditions per manufacturer requirements
- Keep distribution records for traceability
- Report adverse events they become aware of