Korea Medical Device Registration

1
Korea Medical Devices Registration

• http//kobridgeconsulting.com/default-item/south-k
  orea-medical-device-registration/

2
How Kobridge can help for the South Korean market

• Technical document preparation before review by
  MFDS or 3rd Party
• South Korea MFDS mock inspection service
• Medical distributor search and evaluation in
  Korea
• Act as the License holder or importer
• South Korea MFDS Medical device registration and
  approval
• Korean KGMP quality management compliance
• Follow-up post-market activities

3
South Korea Regulations http//kobridgeconsulti
ng.com/default-item/korean-medical-device-regulati
on-training/

• Technical Document Preparation
• Korean Good Manufacturing Practice (KGMP)
• Local representation
• Post-market and vigilance
• Relationship with authorities (MFDS KFDA)

4
Visit http//kobridgeconsulting.com/ for
Following Services

• WHO prequalification of diagnostics
• Korean medical device regulation training
• South Korea medical device registration
• Europe Medical Device Registration