Medical Device Regulations South Korea

MFDS Authority

Medical Device Regulations South Korea

In South Korea, the regulatory submission process for medical devices is overseen by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). The MFDS is responsible for ensuring the safety, efficacy, and quality of medical devices in the South Korean market.  
 
The primary regulations governing medical devices in South Korea include the Medical Devices Act (MDA) and its associated regulations, such as the Enforcement Decree of the Medical Devices Act and the Enforcement Regulation of the Medical Devices Act. Qserve is helping manufacturers worldwide with market access and supports the requirements of the Medical Device Regulations in South Korea.

Medical Device Classification in South Korea

Risk-based classification

Medical devices in South Korea are classified as Class 1, Class 2, Class 3 or Class 4 based on increasing risk. Per risk class the requirements differ for product registration.   
For class I devices there is only the requirement of pre-market notification to the National Institute of Medical Device Safety Information (NIDS). The technical file is not required to be reviewed in this case and neither is there a requirement for QMS certification. For the manufacturers of the other device classes, a QMS conformity assessment is required.  
 
South Korea requires Korean Good Manufacturing Practices (KGMP) certification meaning that an ISO 13485 certificate does not suffice to fulfill the QMS requirements.

Registration Routes South Korea

Medical Device Regulations South Korea

For class II devices there are two possible routes for registration either through certification or through pre-market approval. Devices that can be approved by certification are devices for which there is a substantially equivalent device already on the Korean market. A specific submission needs to be prepared allowing for an evaluation of comparison data with devices already on the market. Product certification is done by NIDS and the final approval is subsequently done by the MFDS. For devices that need to be approved by pre-market approval, a full technical file review needs to be conducted by the MFDS with an emphasis on performance and safety data. This last route generally takes the longest before approval is granted.

 

Representation for foreign manufacturers 

Korea License Holder (KLH) 

Foreign manufacturers need to appoint a local authorized representative also known as a Korea License Holder (KLH) who interacts with the regulatory authorities on the manufacturer’s behalf.  
KLHs (Korea License Holder) must comply with a number of requirements, including: established officially in the territory of South Korea, 

• the employment of a certified Quality Manager, 
• possession of an Import Business License, 
• being an ICC - In-country Caretaker 
• responsibility for each importation and quality control “check,” etc.  

Regulatory timelines and fees 

All documentation that needs to be submitted to the authorities is required to be in the Korean language. Once a registration is completed, it remains valid indefinitely if no changes are made to the device or its intended use.   

Approval timelines will vary depending on the risk class of the device. 

Class I devices in Korea require electronic notification to the Medical Device Information & Technology Assistance Center (MDITAC), accredited by the MFDS for low-risk applications. Unlike the US FDA’s Class I listing system, manufacturers must provide detailed information about their device and technology, but do not need to submit test reports or a KGMP certificate. 

Class II devices in Korea approved and certified more than three times may be announced by the MFDS as 'Recognized Substantial Equivalent (SE) devices.' 

Class III and IV devices require MFDS approval, with Class IV manufacturers needing to submit a technical file in Summary Technical Documentation (STED) format. The STED must be in Korean, though appendices like test reports and risk management files might not need translation. STED requirements are stricter than those for lower-risk devices. 

All Class II-IV applications must include a comparison table to a substantially equivalent device registered with the MFDS. Devices without a South Korean market predicate need clinical data and will undergo Clinical Data Review (CDR) 

Expected registration fees are also dependent on device risk classification and whether or not a registered predicate device or substantial equivalent (SE) device already exists in South Korea.