South Korea (MFDS) Medical Devices Registration

The medical device import market in South Korea was estimated $3.7 billion with majority of US companies holding the larger market share of 47%.

In order to meet the growing demand and need for superior quality of products, MFDS had introduced new registration process for medical devices in 2015.

Classification of Medical Devices in South Korea

The classification and documentation requirements by MFDS for medical devices registration are like global standards. The Notification No 2021-24 from MFDS classifies devices in four risk-based categories. Class I and select Class II devices require certification from NIDS, while other devices require MFDS approval.

Class I: Very Low Risk Devices

Examples: Ophthalmic microscope, Radiation shielding glove, Operation table, Stethoscope, etc.

Class II: Low Risk Devices

Examples: MRI, Pulse oximeter, Sterilizer, Electroencephalograph, etc.

Class III: Moderate Risk Devices

Examples: Cryosurgical(mechanical) system, Anesthesia (gas) system, Silk suture, Condom, etc.

Class IV: High Risk Devices

Examples: Implantable defibrillator, Coronary stent, Biodegradable spine disc, Intraocular lens , etc.​

Medical Devices Registration Pathway in South Korea

For class II, III and IV devices, pre-market approval is required to obtained from MFDS. The registration is valid for 5 years, thereafter it has to be renewed.

The documentation for medical devices registration include General Technical File and Technical Safety and Efficacy Review (SER). The latter is applicable in case there is no predicate/comparative device available in the market. MFDS is responsible for review of technical file for all devices except class I.

Timelines:

The timeline for registration varies depending on the class of device.

Certification of  Class II Device: 5 days

Approval of Class II, III and IV device: 10 days

Technical Documentation Review: 55 days

Clinical Report: 70 days

KGMP Certification:

Quality System Conformity as per Korean Good Manufacturing Practices is required.

License Holder

In order to be a license holder, the manufacturer needs to have a registered place of business in South Korea with a full time quality responsible person. In case of foreign manufacturers, they can appoint a local agent/license holder for applying for registration of medical device in with MFDS.

Artixio's Medical Device Services in South Korea (MFDS)

Gap Analysis

Clinical Evaluation 

Local Representation (Korean License Holder) 

KGMP Quality Conformity Assessment 

KGMP Training 

Technical File Preparation and Submission to MFDS

Translation Support

Distribution and Warehouse Assistance 

Device Registration and Notification 

Post Approval Support 

Medical Device Regulatory Information Management 

Quality Management System Implementation 

Authoring Standard Operating Procedures (SOPs)

Product Specific Quality Training 

Product Testing Assistance