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