“All information in this page are from official MFDS website.”
Approval Process of MFDS (Ministry of Food and Drug Safety)
Regulations at Four hierarchical Orders
- Overview of Notification, Certification and Approval Process in Medical Devices
|MFDS requires the submission of ‘Technical Documents’ for the certification and approval of medical devices.|
Class Ⅰ & Ⅱ devices are certified by ‘Medical Device Information and Technology Assistance Center (MDITAC)’ and some Class Ⅱ (new devices) and Class Ⅲ & Ⅳ devices are approved by MFDS.
- 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.
- 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.
- Premarket Approval
Class I (Notification)
Class II (Certification, Approval)
Class III, IV (Approval)
※ Classification of medical devices– 4 classes(I∼Ⅳ) based on potential risk to human health
– Purpose for use harmonized with GHTF/IMDRF rules
– 2,219 items are designated by ‘Regulations for Product Classification of Medical Device and Class by Product’ in MFDS
|Class||Risk Levels||Device Examples||No. of Devices|
Forceps for medical use, Mechanical Stethoscope
Syringe, Infusion pump
Silk Suture, Ventilator
Premarket Approval Process
MFDS requires the submission of ‘Technical Documents’ for the certification and approval of medical devices.
3.1 Certification of Class II Medical Devices
MDITAC certifies ‘Recognized Substantial Equivalent (SE) devices’, ‘Substantial Equivalent (SE) devices’ and ‘Modified Devices’
“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.
3.2 Approval of Class IIㆍIIIㆍIV Medical Devices
NIFDS (affiliated agency of MFDS) approves ‘New devices (Class Ⅱ)’ and ‘Class Ⅲ & Ⅳ Devices’.
“New(novel) Devices” is a medical device that is not equivalent in the purpose of use, working mechanism or raw materials (Limited to medical supplies) etc. with the already approved medical device.
- International harmonization of STED
Summary Technical Documentation (STED) is required for Class 4(except IVD reagent).
– enforced as of 2014Jan.1st
– enforced as of 2014Jan.1st
STED for demonstrating conformity to the safety and performance of medical devices proposed by GHTF(IMDRF) includes design verification, risk analysis & manufacturing process regarding safety and performance.
- Outside Experts Participatory Review
Outside experts participating in consultation & review for hi-tech and new developed medical devices: 758 experts from each area including medical specialists (clinical, academic, industry, etc.)
- Overview of Manufacturing Business license
MFDS requires those who intend to produce a medical device in Korea, or who intend to import a medical device from overseas to obtain a manufacturing business license and an import business license respectively.
business site is located.
- Document Requirements
- A medical certificate by a doctor that proves an applicant is not a mental patient, or a medical certificate by a medical specialist that proves an applicant is adequate to be a manufacturer.
- A medical certificate by a doctor that proves an applicant is not addicted to drugs or other toxic substances.
- Documents that confirm qualifications of a quality manager.
- Medical devices subject to tracking and control
|52 medical device items are designated as the medical devices subject to tracking and control, which need to be traceable, as they can cause fatal harm to a human body when an adverse event, or a defection occurs while using them. – 48 items that are implanted into a human body for over one year – Four (4) life-sustaining items that can be used in places other than medical facilities|
- Preparation, Preservation, and Submission of Records (Article 50 of the Enforcement Regulations of the Medical Device Act)
Medical device handlers shall prepare records on sales of medical devices by model and manufacturing unit, and users shall prepare records to make it possible to track patients who use a medical device.
Pacemaker, cardiac, implantable 
Prosthesis, vascular, collagen-based 
Pacemaker electrode cardiac, implantable 
Prosthesis, vascular, heparin 
Prosthesis, valve, cardiac, composite 
Prosthesis, valve, cardiac, biological 
Infusion pump, insulin, implantable 
Prosthesis, valve, cardiac, non-biological 
U-healthcare, insulin infusion pump, implantable 
Defibrillator, implantable 
Peripheral nerve electrical stimulation system, analgesic 
Infusion pump, electrically powered, implantable 
Gait-enhancement electrical stimulation system, implantable 
Breast prosthesis, internal, gel-filled 
Incontinence-control electrical stimulation system, implantable 
Electrode/lead, defibrillator, implantable 
Stimulator, electrical, neuromuscular, scoliosis, implantable 
Prosthesis, temporomandibular 
Vagus nerve electrical stimulation system, coma arousal 
Prosthesis, temporomandibular, biological/biodegradable 
Carotid sinus nerve electrical stimulation system 
Prosthesis, mandibular 
Programmer, implantable stimulator, incontinence 
Prosthesis, mandibular, biological/biodegradable 
Bladder/bowel-evacuation electrical stimulation system 
Stent, vascular 
Adaptor, pacemaker lead, implantable 
Coronary artery stent 
Pacemaker repair kit 
Stent, iliac 
Hip prosthesis, internal, total, biodegradable 
Brain electrical stimulation system, psychiatric therapy  (implantable)
Knee prosthesis, internal, total biodegradable 
Stimulator, electrical, antiseizure  (implantable)
Prosthesis, shoulder, internal, total biodegradable 
Brain electrical stimulation system, antitremor  (implantable)
Prosthesis, wrist, internal, total biodegradable 
Stimulator, electrical, analgesic, implantable 
Prosthesis, elbow, internal biodegradable 
Electrode/lead, stimulator, analgesic, implantable 
Prosthesis, ankle, Internal total biodegradable 
Electrode for electrical stimulation system, implantable 
Hip prosthesis, internal, total (approximal surface metal) 
Circulatory assist system, artificial heart 
Ventilator, continuous, home-use 
Diaphragm/phrenic nerve electrical stimulation system 
Defibrillator, low powereds 
Prosthesis, vascular, central 
Defibrillator, high powered 
Prosthesis, vascular, peripheral 
Patient monitoring system, respiratory, radiation procedure (always use)