Regulations at Four hierarchical Orders
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.
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.
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 consist of application form and supportive documents and is divided into two different types: (1) General technical document review; and (2) clinical test review.
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2.1 General Technical Document Review
- Devices substantially equivalent to previously approved products MFDS does not request clinical study reports.
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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
3. 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 | Number of classified devices |
|---|---|---|---|
| I | Little Risk | Forceps for medical use, Mechanical Stethoscope | 594 |
| II | Low Risk | Syringe, Infusion pump | 1,029 |
| III | Moderate Risk | Silk Suture, Ventilator | 338 |
| IV | High Risk | Coronary stent | 256 |
| I~IV | 2 | ||
| Total | 2,219 | ||
Premarket Approval Process
* Some Class II devices are subject to Approval
** Medical Device Infomation and Technology Assistance Center
** Medical Device Infomation and Technology Assistance Center
※ MDITAC, established by MFDS, conducts the business affairs related to certification of medical devices and provides the information and technical support regarding medical devices, including researches on international specifications for improving technologies for medical devices, gathering, analysis, and management of information from domestic and overseas sources
3.1 Certification of Class II Medical Deivces MDITAC certifies 'Recognized Substantial Equivalent(SE) devices', 'Substantial Equivalent(SE) devices' and 'Modified Devices'
Class II
"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.
"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 Deivces
NIFDS (affiliated agency of MFDS) approves 'New devices(Class Ⅱ)' and 'Class Ⅲ & Ⅳ Devices'
NIFDS (affiliated agency of MFDS) approves 'New devices(Class Ⅱ)' and 'Class Ⅲ & Ⅳ Devices'
Class II & III & IV
"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.
4. International harmonization of STED
- Summary Technical Documentation(STED) is required for Class 4(except IVD reagent)
- enforced as of 2014Jan.1st
- optional for other Classes
- 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
5. Outside Experts Participatory Review
- Outside experts participating in consultation & review for hi-tech and new developed medical devices : 758 experts from each areas including medical specialists(clinical, academic, industry, etc)
Overview of Device 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 license approval is handled by a concerning regional office of MFDS in the area where the business site is located.
As an applicant has to possess at least one product license in order to obtain a business license, approval processes of a business license and a product license are conducted contemporaneously.
Business license approval is handled by a concerning regional office of MFDS in the area where the business site is located.
As an applicant has to possess at least one product license in order to obtain a business license, approval processes of a business license and a product license are conducted contemporaneously.
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
- A review for business license approval takes 25 days, and when a product license is finally approved (certified or notified), a regional office of MFDS issues the business license
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.
| Matters to be stated (Article 50 of the Enforcement Regulations of the Medical Device Act) | ||
|---|---|---|
| Handlers | Manufacturers and Importers | a. Quantity of products manufactured/imported by model and manufacturing unit, and date of manufacturing/importing |
| b. Quantity of product sales by model and manufacturing unit, date of sale, and trade name or address of a person who established a medical institution | ||
| c. Other matters required to prevent harm to national healthcare and hygiene | ||
| Distributors and | a. Quantity of product sales by model and manufacturing unit, date of sale, and trade name or address of a person who established a medical institution | |
| Lessors | b. Other matters required to prevent harm to national healthcare and hygiene | |
| Repairers | a. Date of repair by model and manufacturing unit, and trade name and address of a client | |
| b. Other matters required to prevent harm to national healthcare and hygiene | ||
| Users(a person who established a medical institution, etc.) | a. Name, address, date of birth, and gender of a patient who uses a medical device subject to tracking and control | |
| b. Product name, and manufacturing number of a medical device subject to tracking and control, or information recognized as equivalent | ||
| c. Date of use of a medical device subject to tracking and control | ||
| d. Name and location of a medical facility using a medical device subject to tracking and control | ||
| e. Other matters required to prevent harm to national healthcare and hygiene | ||
The designation status of medical devices subject to tracking and control
- 48 items that are implanted into a human body for over one year (item no.1-48)
- Four (4) life-sustaining items that can be used in places other than medical facilities (item no.49-52)
| No. | Device name | No. | Device name |
|---|---|---|---|
| 1 | Pacemaker, cardiac, implantable[4] | 27 | Prosthesis, vascular, collagen-based[4] |
| 2 | Pacemaker electrode cardiac, implantable[4] | 28 | Prosthesis, vascular, heparin[4] |
| 3 | Prosthesis, valve, cardiac, composite[4] | 29 | Annuloplasty ring[4] |
| 4 | Prosthesis, valve, cardiac, biological[4] | 30 | Infusion pump, insulin, implantable[4] |
| 5 | Prosthesis, valve, cardiac, non-biological[4] | 31 | U-healthcare, insulin infusion pump, implantable[4] |
| 6 | Defibrillator, implantable[4] | 32 | Peripheral nerve electrical stimulation system, analgesic[4] |
| 7 | Infusion pump, electrically-powered, implantable[4] | 33 | Gait-enhancement electrical stimulation system, implantable[4] |
| 8 | Breast prosthesis, internal, gel-filled[4] | 34 | Incontinence-control electrical stimulation system, implantable[4] |
| 9 | Electrode/lead, defibrillator, implantable[4] | 35 | Stimulator, electrical, neuromuscular, scoliosis, implantable[4] |
| 10 | Prosthesis, temporomandibular[3] | 36 | Vagus nerve electrical stimulation system, coma arousal[4] |
| 11 | Prosthesis, temporomandibular, biological/biodegradable[4] | 37 | Carotid sinus nerve electrical stimulation system[4] |
| 12 | Prosthesis, mandibular[4] | 38 | Programmer, implantable stimulator, incontinence[4] |
| 13 | Prosthesis, mandibular, biological/biodegradable[4] | 39 | Bladder/bowel-evacuation electrical stimulation system[4] |
| 14 | Stent, vascular[4] | 40 | Adaptor, pacemaker lead, implantable[4] |
| 15 | Coronary artery stent[4] | 41 | Pacemaker repair kit[4] |
| 16 | Stent, iliac[4] | 42 | Hip prosthesis, internal, total , biodegradable[4] |
| 17 | Brain electrical stimulation system, psychiatric therapy[3] (implantable) | 43 | Knee prosthesis, internal, total biodegradable[4] |
| 18 | Stimulator, electrical, antiseizure[4] (implantable) | 44 | Prosthesis, shoulder, internal, total biodegradable[4] |
| 19 | Brain electrical stimulation system, antitremor[4] (implantable) | 45 | Prosthesis, wrist, internal, total biodegradable[4] |
| 20 | Stimulator, electrical, analgesic, implantable[4] | 46 | Prosthesis, elbow, internal biodegradable[4] |
| 21 | Electorde/lead, stimulator, analgesic, implantable[4] | 47 | Prosthesis, ankle, Internal total biodegradable[4] |
| 22 | Electrode for electrical stimulation system, implantable[4] | 48 | Hip prosthesis, internal, total (approximalsurface metal)[3] |
| 23 | Circulatory assist system, artificial heart[4] | 49 | Ventilator, continuous, home-use[3] |
| 24 | Diaphragm/phrenic nerve electrical stimulation system[4] | 50 | Defibrillator, lowpowered[3] |
| 25 | Prosthesis, vascular, central[4] | 51 | Defibrillator, highpowered[3] |
| 26 | Prosthesis, vascular, peripheral[3] | 52 | Patient monitoring system, respiratory, radiation procedure(always use)[2] |
