Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)... Find more on: http://kobridgeconsulting.com/?p=767

1. Medical Device Registration
in South Korea
Nicolas Clary
Kobridge Consulting

2. Today’s Topics
• Korean medical device market characteristics
• Overview of the Korean regulatory process
• Common framework
• Comparison with US and EU process
• Definitions
• General Steps
• Classification
• Substantial Equivalence
• In-country Representation requirements
• Pre-market process (product license)
• Korea Good Manufacturing Practices (KGMP)

3. Easier than it seems
Lost ? Easier than you would think…

4. The MARKET

5. The Market
• Similar as US and EU market
• Established market
• Opportunities based on replacement of the installed
base or new technologies
• Very regulated and « Opaque » market
• More similarities with US market and regulations

6. The Market
• Most doctors study in US then expect to find the
same technology in Korea
• High influence on the choice of products by doctors
especially when used in US
• The market path could be then first US clearance and
then South Korea

7. South Korean
Regulatory Process

8. The South Korean Regulatory
Process for Medical Devices
Since 2013:
The former Korea Food and Drug Administration
(KFDA), an agency under MHW, regulating all Medical
Devices was promoted to ministry level: Ministry of
Food and Drug Safety (MFDS).
The legal framework for the regulatory system is
based on the Medical Devices Act No. 10564. Medical
devices must meet the requirements of the Medical
Devices Act, and obtain registration with the MFDS
before being sold in the country.

9. The major steps
1. Determine the class of the product
2. Establish an equivalence
3. Assign a « License Holder »
4. Prepare the file
5. Tests
6. Review (with or without technical file)
7. KGMP certification (if required)
8. Place on the market

10. General Consideration about
framework

11. Where to start
from?
 Most applicants have
their products already
registered in US or EU.
 Therefore it is useful
whenever possible to do
a comparison analysis
between the 3 markets

12. Participants in ensuring the safety of
medical device

13. Interested parties of medical devices
in Korea, EU and USA
Korea EU USA
Medical Device Act Medical Device
Directive
Federal Food Drug &
Cosmetic Act
Manufacturer Manufacturer Manufacturer
Registered Importer Authorised
Representative
U.S. Agents
MFDS Notified Body FDA
Medical Device
Technical Document
Review Agency
Third Party

14. Common stages of government
regulations

15. Common framework for medical
device regulations
STAGE PRE-MARKET PLACING ON-MARKET POST-MARKET
CONTROL/
MONITOR
PRODUCT SALE AFTER-SALE/USE
PERSON MANUFACTURER VENDOR VENDOR/USER
Items or activities
regulated
Device attributes
• Safety and performance
Establishment registration
• List products available or
in use
• Requires vendor to fulfill
after-sale obligations
Surveillance/vigilance
• After-sale obligations
• Monitoring of device’s
clinical performance
• Problemidentification
and alerts
Manufacturing
• Quality systems
Labelling
• Accurate description of
product
• Instructions for use
Advertising
• Prohibits misleading or
fraudulent advertisement

16. Definition

17. Definition of Medical Device
 Korea (Medical Device Act) - Chapter1, Article 2
 For the purpose of this Act, the term "medical device" means any instrument,
machine, contrivance, material or similar article that is used on human beings or
animals either alone or in combination with other devices and that falls under any of
the following Items provided below. However, drugs or quasi-drugs under the
Pharmaceutical Affairs Act or, among the disabled-assistive-devices under Article 65 of
the Act for Welfare of the Disabled, artificial limbs and orthotics shall be excluded:
 1. Articles used for the purpose of diagnosis, cure, alleviation, treatment, or prevention
of illness;
 2. Articles used for the purpose of diagnosis, cure or alleviation of or compensation for
an injury or disability;
 3. Articles used for the purpose of test, replacement, or modification of the structure
or functions [of the body]; or
 4. Articles used for the purpose of control of conception.

18. Definition of Medical Device
 EU(MedicalDevice Directive –93/42/EEC amended by 2007/47/EC) - Article 1
 ‘medical device’ means any instrument, apparatus, appliance, software, material or
other article, whether used alone or in combination, including the software intended
by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes
and necessary for its proper application, intended by the manufacturer to be used for
human beings for the purpose of:
 -diagnosis, prevention, monitoring, treatment or alleviation of disease,
 -diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap,
 -investigation, replacement or modification of the anatomy or of a physiological
process,
 -control of conception,
 and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means;

19.  USA (the Federal Food Drug & Cosmetic Act) - 201(h)
 A device is"an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component part, or
accessory which is:
 •recognized in the official National Formulary, or the United States Pharmacopoeia,
or any supplement to them,
 •intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
 •intended to affect the structure or any function of the body of man or other animals,
and which does not achieve any of it's primary intended purposes through chemical
action within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its primary intended
purposes."

Definition of Medical Device

20. Definition of Medical Device
 Comments on the different definitions
 The main difference between the Korean definition
and the other two is:
 In Korea, drugs and quasi-drugs are exclude from the
scope of the medical devices
 Caution: some gels, lotions or similar product could fall
in that category

21. Summary of the major steps

22. Steps to MFDS Compliance
1. Determine medical device status and classification
2. Determine Substantial Equivalent (SE) availability
3. Korea License Holder assignation
4. Application preparation
5. Product testing (as required)
6. Application (with Technical File as required) review
7. KGMP Certification (as required)
8. Place products on market

23. Classification

24. Device Status and Classification
Class 1
(low risk)
Class 2
(Medium
Risk)
Class 3
(Medium-
High Risk)
Class 4
(High Risk)
Increasing risk for the patient

25. Classification of Medical Device
Korea EU USA
KFDA Notification No.
2010-91
MDD Annex IX 21 CFR 862-892
Class 1
Class 2
Class 3
Class 4
Class I , Class I (sterile,
measure)*
Class IIa
Class IIb
Class III
Class I
Class II
Class III
Classification of
medical devices are
already defined
Classify according to
the classification Rule
(Rule 1 ~ Rule 18)
Classification of
medical devices are
already defined

26. Conformity assessment procedure
Class of
medical devices
Risk classification Approval or Certification
Class 4 High risk Product approval by MFDS
Clinical data
Class 3 Medium risk Product approval by MFDS
Class 2 Low risk Product approval by MFDS
Technical document review
by 3rd Party
Class 1 Extremely low risk Product notification to
MFDS

27. Substantial Equivalence

28. MFDS Substantial Equivalence (SE)
Substantial equivalency is supported by proper scientific
rationale or supporting documents. A comparison table
exists for each category of product with the following
criteria:
 Intended use
 Principle of action
 Raw material (for patient contact)
 Performance
 Testing method / standard
 Instruction for use

29. MFDS Substantial Equivalence (SE)
If the device has a substantial equivalent already sold in
Korea no SER (Safety and Effectiveness Review) is
needed.
On the contrary SER is required if the equivalency
cannot be proven.

30. Classification of Medical Device
Korea EU USA
Substantial Equivalence
(SE)
None Predicate Device
SER (Safety and
Effectiveness Review)
None PMA (Pre-Market
Application)

31. In-Country Representation

32. A strategy
you must
define

33. Korea License Holder Requirements
The role of the Korea License Holder (KLH) is to
coordinates and submits your medical device
registration application to the MFDS on your behalf.
It is essential to appoint a KLH as your representative
if you don’t have any local business in South Korea

34. The strategy
3 Options:
 Distributor only (the distributor takes care of everything):
registration, licenses, post-market follow-up, sales,
marketing
 License holder + distributor: same as above except license
holder does registration, licenses, post-market follow-up
 Subsidiary: establish your subsidiary in South Korea. The
subsidiary becomes the license holder. A consultant takes
care of the registration.

35. Different entities involved
Korea EU USA
Medical Device Act Medical device, in-vitro
diagnostic directives
Federal Food Drug &
Cosmetic Act
Manufacturer Manufacturer Manufacturer
License Holder European
Representative
U.S. Agents
MFDS Notified Body FDA
Third Party Third Party

36. Pre-market process
(product license)

37. Class I Devices: Premarket
Notification
• Class I standard device
applications are considered
accepted to the MFDS branch
office
• The Premarket Notification
contains basic information on
your medical device

38. General Technical File Preparation
For Class II, III and IV medical devices
with proven Substantial Equivalence,
manufacturers must prepare a
General Technical File.
The General Technical File is similar to
a US FDA 510(k) submission.

39. Safety and Effectiveness Review
(SER) Technical File Preparation
Manufacturers of Class II, III
and IV devices without
Substantial Equivalence must
prepare SER Technical File
submissions.
The SER Technical File is
similar to the US Premarket
Notification submission.

40. SER Technical File Preparation:
Clinical Data Requirements
• Clinical data must be included in SER Technical File
submissions to the MFDS
• Clinical trials in Korea are typically not required
• KFDA often accepts clinical data that has already been
approved by an OECD member country or published
in an SCI-listed scientific journal

41. Type Testing Requirements
• All Class II, III and IV medical
devices must undergo type
testing by an independent
laboratory.
• Existing equivalent product
testing may meet this
requirement, as long as it
complies with ISO, IEC, ASTM or
GLP standards.

42. MFDS Certified Test Laboratories
 14 certified test laboratories
 Some of them have a full scope
 Other have limited scope
 Some are specialized in dental products
 Determination of the acceptance of foreign test
reports made by MFDS-authorized test labs

43. Technical File Submissions
Once your Technical File is prepared, it must be
submitted to the appropriate reviewer for approval.
Class 2: reviewed by 3rd party, approved by MFDS
Class 2,3,4 (SER or not): reviewed and approved by
MFDS

44. KFDA Regulatory Timeframes and
Costs
MFDS
Classification
Review Time Fees
Class 1 NA $35
Class 2 35 days $1500
Class 2 SER 80 days $450
Class 3 and 4 65 days $195
Class 3 and 4
80 days $450
SER

45. MFDS Authorized Third-Party
Reviewers
There are 6 companies authorized by the MFDS to
perform reviews of Class 2 General Technical Files. It
includes:
Notified Bodies
Korean test laboratories

46. Product License
Once the technical file (SER or not) is approved, the
submission process continues in order to obtain the
product license
It is recommended to submit at the same time the
request for KGMP certificate

47. Korea Good Manufacturing
Practices (KGMP)

48. An inspection ?
Very much similar as an ISO
13485 audit

49. Korea Good Manufacturing Practices
(KGMP)
Korea EU US
KFDA Notification No.
2010-93(Amended on
December 27, 2010)
Standards for
Manufacture, Import and
Quality Management of
Medical Device
EN ISO 13485: 2012 21 CFR Part 820
Quality System
Regulation (QS)/
Good Manufacturing
Practices (GMP)
Annex II
Section 3 (Quality system)
Section 5 (Surveillance)
Annex V
Section 3 (Quality system)
Section 4 (Surveillance)
Annex VI
Section 3 (Quality system)
Section 4 (Surveillance)

50. Korea Good Manufacturing Practices
(KGMP)
 Manufacturers of class 2, class 3 and class 4 are
required to comply with KGMP requirements
 The quality system compliant with KGMP is very much
similar to ISO 13485
 Onsite verification of the data from the Device Master
Record

51. KGMP Certification Process
 Preparation of the documents
 Submission 2 months before the expected date of the
inspection (in parallel with the submission of the
technical file)
 Review by 3rd Party and MFDS
 Onsite Inspection
 Issue the certificate (valid 3 years)

52. KGMP Certification Process
KGMP inspections are performed by MFDS inspector
and 3rd Party
4 Korean laboratories are accredited to perform
KGMP inspection

53. Final registration
Following the approval, MFDS delivers a
product license and a KGMP certificate
Customs clearance of the product is done
by the “license holder”

54. Thank You !
Nicolas Clary
Kobridge Consulting
+82 2 3450 1690
Nicolas.clary@kobridgeconsulting.com
www.kobridgeconsulting.com