Understanding Medical Device Registration in South Korea  

Regulatory Authority

The Ministry of Food and Drug Safety (MFDS)

The Korea Medical Devices Industry Association (KMDIA), the largest association of over 900 medical devices companies, aims to improve public health and boost industry growth by partnering with its members to lead technological advances in the 21st century.

Link for Regulatory Authority

https://www.mfds.go.kr/eng/index.do

Local Regulation

Medical Device Act (MDA)

Classification of Medical Devices

• Medical Devices: Class I, II, III and IV
• IVDs: Class I, II, III and IV

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.
In principle, Class I & II devices are certified by Medical Device Information and Technology Assistance Center (MDITAC) the National Institute of Medical Device Safety Information (NIDS) and Class III & IV devices are approved by MFDS. However, Class I & II devices in the categories below must be approved by MFDS.

• which require clinical test reports
• Digital Healthcare related (ex. telemedicine system)
• Undefined Nomenclature & classification regulation
• Combined with pharmaceuticals, etc.

Listing or Registration Requirements

• Classify the medical device
• Appoint an Authorized Korean License holder
• Apply for KGMP Certification 4. Submit Certification/ Approval
• 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.

Documents Required for South Korea Medical Device Registration

1. Technical Documents

• Documents related to quality of medical devices, such as performance and safety, etc.
• Which include information on ‘Intended Use,’ ‘Mechanism of action (MoA),’ ‘Operational (Functional) Structure,’ ‘Raw Materials,’ ‘Instruction for Use,’ ‘Test Specifications,’ etc.

2. Technical Document Classification

The technical documents consist of ‘Application Form’ and ‘Supplementary Evidence.’ The presence of mandatory submission of ‘clinical trial reports’ (as a part of ‘Supplementary Evidence’) determines application procedure to be followed.

• General Technical Document Review

If a device is substantially equivalent to legally marketed devices, ‘clinical trial reports’ are not required.

• Safety and Efficacy Review (SER)
  • The technical document including ‘clinical trial reports’ is thoroughly reviewed
  • ‘Clinical trial reports’ are required if differences such as ‘Intended Use,’ ‘Mechanism of Action (MoA)’ and ‘Raw Materials’ could significantly affect safety and efficacy of devices

3. Premarket Approval

• Class I (Notification)
• Class II (Certification, Approval)
• Class III, IV (Approval)

Premarket Approval Process:

• MDITAC

Class I Approval Process: Notification

• Application for notification
• QMS requirements

Class II Approval Process: Certification

• Application for certification
• QMS requirements
• Timeline: Certification – 5 days
• NIFDS

Class II, III and IV Approval Process: Approval

• Technical Document Review
• QMS Requirements
• Timeline:
  • Technical Document: 55 days
  • Clinical trial: 75 days

Certification of Class II Medical Devices

• “SE Device” is a medical device (or an IVD) that is equivalent in ‘Intended Use,’ ‘Mechanism of Action (MoA),’ ‘Raw Materials, ‘Performance,’ ’Test Specification’ (not applicable to IVD), ‘Instructions for Use’ (not applicable to IVD) with previously approved/certified/notified medical devices. ※ For medical devices in Class II that were approved and certified for more than three times with the equivalent product, MFDS may officially announce those as a ‘Recognized Substantial Equivalent (SE) devices’
• “Modified Device” is a medical device(or an IVD) that is equivalent in ‘Intended Use’, ‘Mechanism of Action(MoA)’, ‘Raw Materials(Limited to implanted/contacted devices & most of devices are not intended to operate electrically, not applicable to IVD)’ with previously approved/certified/notified medical devices, but not equivalent in ‘Raw Materials’(only applicable to IVD) ‘Performance’, ’Test Specification’ (not applicable to IVD), ‘Instructions for Use’ (not applicable to IVD).

Approval of Class II, III and IV Medical Devices

NIFDS (affiliated agency of MFDS) approves ‘New devices (Class II)’ and ‘Class III and IV Devices’

Class II, III and IV devices must submit:

• Technical File
• S&EP Data
• Clinical Trial Reports
• Test Reports
• IFUs, Labelling

Registration Timeline

• Class I (NIDS) – 1 Month
• Class II(NIDS)- 3-5 months
• Class III- 9 months
• Class IV – 9-12 months

Registration Fee

• Class I: ₩85,000 (approx. US$73).
• Class II:
  • PMA with SER: ₩130,000 (approx. US$112).
  • PMA without SER: ₩1,495,000 (approx. US$1,283)
  • SPMA: ₩130,000 (approx. US$112)
• Class III & IV:
  • With SER: ₩719,000 (approx. US$617)
  • Without SER: ₩1,495,000 (approx. US$1,283)

SER- (registered predicate or Substantial Equivalent (S.E.) exists in Korea.)

License Validity and Renewal

Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.

Special Labelling Requirements

Label and instructions for use must be provided in Korean

Additional Comments

All application files must be available in Korean language

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk