Entering the South Korean market involves a regulatory process that is well defined but unfamiliar to most manufacturers approaching it for the first time.
Working with our trusted South Korean partner, Compliance Management Solutions provides end to end support for medical device registration in South Korea and acts as your Authorised Representative.
Our services include
- Regulatory strategy and pathway guidance
- Preparation and review of technical documentation
- Liaison with the Korean regulatory authority, the MFDS
- Acting as your local Authorised Representative
- Ongoing compliance and post-market support
Whether you are launching a new device or expanding an existing portfolio into additional markets, please contact our regulatory team to discuss South Korean registration.