010-MFDS: Medical Device Approval

“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.
  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.

 

  1. 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.

 

  1. 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
ClassRisk LevelsDevice ExamplesNo. of 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

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.

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.

 

  1. 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.

 

  1. 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 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.
  • 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.

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

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

Electrode/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 (approximal surface 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, low powereds [3]

25

Prosthesis, vascular, central [4]

51

Defibrillator, high powered [3]

26

Prosthesis, vascular, peripheral [3]

52

Patient monitoring system, respiratory, radiation procedure (always use) [2]