All medical devices are regulated by Ministry of Food and Drug Safety (MFDS) as part of Ministry of Health and Welfare (MOHW)
Medical Device Definition
The term "medical device" means an instrument, machine, device, material, or any other similar product specified in the following subparagraphs as one used, alone or in combination, for human beings or animals
Classification of Medical Device
International Classification
Risk base Medical Device Classification
Risk Level
Type of regulation
Class I
Devices with extremely low risk to the human body in case of problems
Ex) Forceps for medical use, Mechanical
Little
Approval/certification not required (Notification/self declaration)
Class II
Devices with relatively low risk to the human body in case of problems
Ex) Syringe, Infusion pump
Low
Certification by Medical Device Information and Technology Assistance Center (MIDTAC)
Approval by the National Institute Food and Drug Safety (NIFDS)
Class III
Devices with relatively high risk to the human body in case of problems
Ex) Silk Suture, Ventilator
Moderate
Approval by the NIFDS
Class IV
Devices highly invasive to patients and with life-threatening risk in case of problems
Ex) Coronary stent
High
Premarket Approval Process *
Class I
Class II(Modified & Equivalent)
Class II(New)
Class III
Class IV
Notification by MIDTAC
Certification by MIDTAC
Approval by NIFDS
KRW 35,000 +
5 days, KRW 42,000 +
10 days, KRW 402,000 +
Application for product notification
Application for product verification
Summary Technical Document (STED) by 3rd party
55 days for STED, 70 days for Clinical report KRW 1,400,000 +
Quality Management System (QMS) requirement submission to MIDTAC or NIFDS
Notes
Device registrations do not expire
International harmonization of STED: STED is required for Class 4(except IVD reagent)
Outside Experts Participatory Review: Outside experts participating in consultation & review for hi-tech and new developed medical devices
Source: Ministry of Food and Drug Safety site * See Appendix 1,2,3
Appendix 1Appendix 2Appendix 3
1. Technical Document
Documents related to quality of medical devices, such as functions, safety. etc
Includes information on raw materials, structure, purpose of use, instruction for use, principles of functions, precautions for use, test standards, etc.
2. Technical document classification
The technical document is consisting of application form and supportive documents and is divided into two different types: (1) General technical document review; and (2) clinical test review
2.1 General Technical Document Review
Devices substantially equivalent to previously approved products MFDS does not request clinical study reports
2.2 Review of Technical Documents Review for Safety and Efficacy Review (SER)
Review of Technical Documents Review for Safety and Efficacy Review (SER)
Scope: (Significant difference affecting safety and efficacy) New Developments, New performance, New structure, New purpose for use Clinical test reports are essential
“Modified Device” is a medical device that is equivalent in the purpose of use, working mechanism, raw materials (Limited to medical supplies) with the already approved medical device, but not equivalent in performance, test specifications, instructions for use, etc
“SE Device” is a medical device that is equivalent in the purpose of use, working mechanism, raw materials (Limited to medical supplies), performance, test specifications and instructions for use with the already approved medical device
“Recognized SE Device” is a recognized medical device that is equivalent in the purpose of use, working mechanism, and so on defined by MFDS
Source: Ministry of Food and Drug Safety site
Need More Information
Start Registration in
Korea
Thank you for requesting a demo for RegDesk Dash. Your request has been received and a member of our team will reach out to you shortly to schedule your demo presentation.