The document discusses the new IVD Medical Device Act in Korea and its impact on the Korean IVD industry. It provides a history of IVD regulations in Korea and an overview of the key aspects of the new Act, which was enacted in April 2019 and will be enforced starting May 2020. The new Act establishes a risk-based classification system for IVD devices and requirements for clinical laboratory accreditation for IVD testing. It is expected to harmonize Korean regulations with international standards and reduce regulatory burden through changes like a negative system for product changes.

1. The world leader in serving science
Leejoon Kim
RA QA manager
Thermo Fisher Scientific, Korea
New IVD Medical Device Act
and Korea IVD Industry
July 16, 2019

2. 2
KR IVD Industry – Market Size

3. 3
KR IVD Industry – Legal Entities

4. 4
KR IVD Industry – Product Registration Status

5. 5
1953
Controlled under
Pharmaceutical Affairs Act
2004
Established and enforced
Medical Device Act.
But IVD reagents controlled under
Pharmaceutical affairs Act.
2011
Revised Enforcement Rule
of Medical Device Act.
to control the IVD reagents part
of Medical Devices
2014
Change name from IVD
reagents/IVD medicine to
IVD medical device
under regulation
2019
Enacted
New IVD Act on April
2020
IVD Act will be enforced
in May
History of IVD regulations in Korea

6. 6
Overview of new IVD Act in Korea
• New IVD Act, separate from Medical Device Act
• Enactment on April 30, 2019
• Enforcement from May 1, 2020
• The key contents of IVD Act are;
 Definition of the IVD medical devices including IVD reagents, equipment and software.
 Risk-based approach to classification
 Co-approval process for the companion diagnostics and the medicines
 Introduction of the clinical performance test system for the IVD devices
 Defined the requirements of Clinical Laboratory Accreditation from MFDS for hospitals or laboratories
conducting IVD testing
 Negative system for the product change control

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Class 4 Class 3 Class 2 Class 1
• High individual risk and
high risk for public health
• e.g. HBV, HCV, HIV,
ABO/Rh(D) blood grouping
• High individual risk and/or
moderate risk to public
health
• e.g. Genetic tests, cancer
markers, blood glucose
meters/strip
• Moderate individual risk
and/or low risk to public
health
• e.g. clinical chemistry,
self-test device listed as
not class 3
• Low individual risk and low
risk to public health
• e.g. instruments, nucleic
acid extraction reagents,
controls
IVD devices will be divided into four classes, according to intended use and the potential risk to individuals and public health
1. Will be adopted from IMDRF classification rule for IVD medical devices.
2. For devices with multiple intended purposes, all purposes must be classified, and the highest risk class is applied.
Classification will be harmonized with the international regulations (e.g. IMDRF, EU IVDR),
which will reduce the burden on industry for fulfill the regulatory requirements
Classifications of IVD medical devices (Draft)

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Clinical Laboratory Accreditation for IVD Testing
 For the use only within the applicable laboratories, it is intended for use of self-designed and
configured IVD medical devices.
 Accredited laboratory shall obligate the requirements described in Enforcement Rule.
 NGS (Next-generation Sequencing) Clinical Laboratory Accreditation
 Already implemented before new IVD Act was enacted.
 Requirements of Accreditation of Clinical Lab
1. Quality management system of clinical laboratory
2. Proficiency of laboratory personnel
3. Performance evaluation of IVD testing

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Detailed regulatory requirements and the scope of clinical laboratory accreditation in
the field of IVD test
 Will be confirmed in the Enforcement Decree and the Enforcement Rules of IVD law.
Clinical Laboratory Accreditation for IVD Testing (cont.)
 Accredited clinical laboratory shall be following;
1. Reporting of annual test outcome
2. Retention of the documents related to laboratory testing
3. Compliance with quality management system
 Guidelines for NGS Clinical Laboratory Accreditation published by MFDS
 NGS clinical laboratory Accreditation (Revised on Jun. 01, 2017)
 Performance evaluation of NGS in vitro diagnostic medical devices (Revised on Jul. 31, 2018)
 NGS Clinical Laboratory Accreditation for the field of testing
• Noninvasive prenatal test(NIPT) (Revised on Feb. 7, 2018)
• Germline (Revised on Feb. 7, 2018)
• Somatic (Revised on Feb. 7, 2018)

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1 2 3 4 5
Roll out
New IVD Act
(Apr. 30, 2019)
Final draft
Enforcement Decree
& Rule
(2019)
Initial proposal
MFDS notifications
(2019)
Enforcement
New IVD Act
(May 01, 2020)
Enforcement
Enforcement Decree &
Rule (May 01, 2020)
Advantages
• Regulation according to the characteristics of IVD
medical devices
• Harmonization of International standards and
regulations
• Change control : Negative system (License revision
only for the major changes)
Disadvantages
• The burden of industry to expand the scope of
reviewing both of current Medical Device Act and the
new IVD Act
New IVD Act : Impact on Medical Device Industry

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Act on Nurturing Medical Device Industry and Supporting
Innovative Medical Devices (short title: Medical Devices Industry Act)
• Overview
• Enactment on April 30, 2019, enforcement from May 1, 2020
• To support medial devices industry and accelerate the commercialization of innovative medical
devices
• The key contents of Medical Device Industry Act are;
 Certification and the support of innovative medical devices companies
(e.g. priority of participation of national R&D project, reduction of taxes, exception of research facility, exemption from
various charges, etc.)
 Fast track of the product approvals
 Exemption of some documents for the innovative medical software
 Support for clinical trial
 Comprehensive support center for the medical devices industry

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MFDS
(Ministry of Food and Drug
Safety)
Product Registration
(Notification, Certification,
Approval)
• No Technical Review : 5
Days
• Technical File Review : 65
Days
• Clinical Data Review : 80
Days
• Certified Labs’ Technical
File Review : 25 Days
HIRA
(Health Insurance Review &
Assessment Service)
Designation of New or
Existing Reimbursement
Claim
• 30~60 Days
HIRA
(Health Insurance Review &
Assessment Service)
The Economics and
Reimbursement
Appropriateness
(Reimbursement Decision)
• 100 Days
NECA
(National Evidence-based
Healthcare Collaborating
Agency)
new Healthcare
Technology Assessment
(nHTA)
• 140 Days ( +140 Days
Added If In-depth Review
Required)
Introduction - Registration and Reimbursement Process

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MFDS HIRA NECA HIRA
MFDS Approval
Designation of New
or Existing
Reimbursement
Claim
nHTA
(new Healthcare
Technology
Assessment)
Final Confirmation
on Reimbursement
Claim
NHTA not required
for IVD
(Post Evaluation
after the grace
Period)
Final Confirmation
on Reimbursement
Claim
New
IVD-Market Access First, Post Evaluation

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DTC (direct-to-consumer) Testing
DTC Genetic testing controlled under Bioethics and Safety
Act. (Not controlled by New IVD law)
Accredited genetic testing can be provided to customer
for 12 items & 46 genes.
Ministry of Health and Welfare has been conducting a pilot
project of DTC genetic testing service accreditation until
September 2019.
In pilot project of DTC accreditation, the testing items
expanded up to 57.

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