Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
MFDS
Register your medical device in South Korea.
Register your medical device through the MFDS (Ministry of Food and Drug Safety) under the Medical Devices Act, with a dedicated KMAH and Korean KGMP certification.
Speak to a specialistThe authority
Ministry of Food and Drug Safety
MFDS
Since 2013
South Korea
The South Korean government agency responsible for regulating medicines, medical devices, food and cosmetics. It succeeded the KFDA in 2013 and is a regulatory reference across Asia-Pacific for its technical quality and international standards.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, simple Notification | Bandages, gauze, basic instruments |
| Class II | Low-to-moderate risk | Contact lenses, diagnostic equipment |
| Class III | Moderate-to-high risk, requiring technical review | Infusion pumps, surgical equipment |
| Class IV | High risk, requiring intensive clinical review | Cardiac implants, prostheses, pacemakers |
Registration process
How we manage your project
- 01
KMAH1-2 months
Appoint a Korean KMAH (Korea Marketing Authorization Holder), mandatory for foreign manufacturers
- 02
Classification3-4 weeks
Determine the class under the MFDS catalogue (IRMD coding)
- 03
KGMP6-12 months
Korea GMP certification (QMS audit) is mandatory for Class II and above
- 04
Technical dossier4-6 months
Prepare Pre-Market Approval (PMA) or Notification in Korean
- 05
MFDS reviewvariable
Class I Notification: 14 days. Class II/III: 60-80 days. Class IV: 120-180 days
- 06
Final approval and commercialisation2-3 weeks
Licence issued and device eligible for commercialisation in Korea
Total timeframeClass I: 3-4 months. Class II: 8-12 months. Class III: 12-18 months. Class IV: 18-30 months
Local representativeKMAH (Korea Marketing Authorization Holder)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | Adverse event reporting through the Korea Medical Device Adverse Event System and annual reports |
| Renewal | Indefinite licence; KGMP certification renewable every 3 years |
| Required QMS | KGMP (Korea GMP) and ISO 13485 (accepted as a reference) |
How HSC helps
South Korea in 8 to 18 months, with a dedicated KMAH and structured KGMP.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about MFDS
Next step
Ready to start your project in South Korea?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist