Korea Medical Device Regulations

Agency
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 ClassificationRisk base Medical Device ClassificationRisk LevelType of regulation
Class IDevices with extremely low risk to the human body in case of problems Ex) Forceps for medical use, MechanicalLittleApproval/certification not required (Notification/self declaration)
Class IIDevices with relatively low risk to the human body in case of problems Ex) Syringe, Infusion pumpLowCertification by Medical Device Information and Technology Assistance Center (MIDTAC)Approval by the National Institute Food and Drug Safety (NIFDS)
Class IIIDevices with relatively high risk to the human body in case of problems Ex) Silk Suture, VentilatorModerateApproval by the NIFDS
Class IVDevices highly invasive to patients and with life-threatening risk in case of problems Ex) Coronary stentHigh
Premarket Approval Process *
Class IClass II (Modified & Equivalent)Class II (New)Class IIIClass IV
Notification by MIDTACCertification by MIDTACApproval by NIFDS
KRW 35,000 +5 days, KRW 42,000 +10 days, KRW 402,000 +
Application for product notificationApplication for product verificationSummary 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

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