MFDS MedicalMedical Devices Act
Korean Medical Device Regulatory Framework
South KoreaMinistry of Food and Drug SafetyGeneral
What this code is
Medical Devices Act is the official MFDS identifier for “Korean Medical Device Regulatory Framework”. Medical Devices Act is the official identifier MFDS uses for this instrument.
- Instrument
- Medical
- Full name
- Medical Devices Act
- Category
- General
Source links
- Authority source
- English
- Readable HTML
- Not available yet
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Use the official source while a readable HTML version is being prepared.
Dates
- Published
- —
- Effective
- —
About this regulation
Korean Medical Device Regulatory Framework
MFDS overview of the Medical Devices Act, its enforcement rules, risk classes I–IV, and the notification, certification, and approval pathways for devices marketed in Korea.
Medical Devices Act is the official identifier MFDS uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.