Med-Info

International expert information

Introduction to
for the medical device industry Korean medical
device regulations

The Ministry of Food and Drug Safety (MFDS) is MFDS standards and guidelines related to
the healthcare agency having overall responsibility medical devices
for medical devices in Korea. MFDS standards are published upon demands from the
industry and assessors, referring to widely recognized
Structure of Korean legislation international standards, e.g. IEC and ISO standards, but
considering national deviations. The standards are:
ƒƒ Medical Devices Act (MDA)
ƒƒ Horizontal standards for electrical safety,
ƒƒ Enforcement Decree of MDA
biological safety, electro-compatibility and safety
ƒƒ Enforcement Regulations of MDA – framework
testing requirements
of major regulatory programs and basis for GMP
ƒƒ Vertical standards for respective product categories
requirements in Annexes
ƒƒ MFDS notifications of MDA – most detailed
Guidelines as nonbinding documents are published for
regulations for technical requirements, review industry and MFDS assessors. Examples are:
standards, and processes* ƒƒ Guideline on medical device evaluation
ƒƒ MFDS standards and guidelines – guidelines for ƒƒ Guidelines on technical document review
industry and MFDS assessors ƒƒ Guideline on labeling for medical devices
ƒƒ Guideline on GMP audit
MFDS notifications related to medical devices ƒƒ Guideline on GMP audit for foreign manufacturers
Under the legislations, most detailed regulations for of imported products
technical requirements, review standards, and processes
are regulated as MFDS notifications. Some important
notifications for device registration process are:
ƒƒ Regulation on approval, notification, and assessment
of medical devices
ƒƒ Standards for manufacture and quality management
of medical devices (GMP)
ƒƒ Regulations for product classification of
medical devices * The regulations with most current versions are to be checked via the MFDS
website (www.mfds.go.kr). The laws and notifications are partly available in
ƒƒ Re-evaluation (re-examination) of medical devices English, but not always as latest versions.

TÜV SÜD Product Service GmbH

Classification of medical devices (MD) and
responsible organizations

Class* Criteria Product assessment** Product approval GMP audit

TDR SER
IV Medical devices with
high risk MFDS,
III Medical devices with MFDS MFDS Head Office
Third-party GMP inspector
medium serious
+ MFDS officer
potential risk
II Medical devices with Third-party TF MFDS MDITAC***
low potential risk reviewer
I Medical devices with – MDITAC***
n/a
little potential risk

* The classification of each medical device is listed in a MFDS notification.

** A technical document review is a “general” technical file review (TDR) for those products that are basically the same as an already approved product, whereas
a “safety and efficacy” review (SER) is required for devices unlike those currently available on the market – falling under new structure, new performance, new
intended use, and newly developed medical devices.

*** Medical Device Information & Technology Assistance Center

Importer Premarket requirements

To access the Korean medical device market, the For marketing medical devices, the following requirements
importer based in Korea is to be designated for foreign are to be fulfilled:
manufacturers, and has to be: ƒƒ Product license
ƒƒ a business license holder for medical device import, ƒƒ Quality system regulation – KGMP audit and approval
ƒƒ possibly a subsidiary of a foreign manufacturer, an
independent distributor, local manufacturer or other Product license
legal entity, All medical devices require a premarket ­registration from
ƒƒ an applicant for product registration process and MFDS before importing and putting on the ­market. There
ƒƒ responsible for postmarket surveillance. are two types of premarket product ­licenses:
ƒƒ Premarket notification for Class I devices
ƒƒ Premarket approval for Class II, III and IV devices
Premarket registration

Class Class
I II, III, IV

Notification Approval

Application for Application for

Application for
general technical safety and
product notification
document review efficacy review

Technical documents Technical documents

Test reports Test reports

Clinical study reports

Premarket notification for Class I devices

Premarket notification requires only a documentary
review of product information.

Auto-registration by the online submission MFDS systems

Manufactures (an electronical
or importers window for civil
A certificate of medical devices notification petitions to MFDS)

will be available online

MFDS does not accept:

ƒƒ Submission for a medical device requiring the approval process
ƒƒ Submission for a nonmedical device

Premarket approval for Class II, III and TÜV SÜD Korea is a third-party reviewer organization for
IV devices technical document review for all product categories
For Class II medical devices the application must be of Class II medical devices.
submitted to MDITAC for product approval, after complete
technical document review by third-party reviewers. For Class III and IV medical devices the application has
to be submitted to MFDS, Head Office, for product
approval after technical document review by MFDS.
 Notification of
Application for Application for
conformity from Certificate of
review of certificate of
technical document product approval
technical documents product approval
review

In case of Class III and IV devices the applications for In addition to TDR, SER requires:
technical document review and for product approval ƒƒ Original developer
can be submitted together. ƒƒ Clinical investigation data
ƒƒ Design history and background
The application for certificate of product approval ƒƒ Market history in foreign countries
is a formal process by MFDS without any further
technical review. In the product registration procedure, the Class II medical
devices defined as “equivalency-notified products” are
Technical document review exempt from the technical document review process, and
A technical document review is a general “technical those defined as “modified products” are partially exempt.
document review” (TDR) for those products that are
basically the same as an already approved product, What is a “equivalency-notified product”?
whereas a “safety and efficacy review” (SER) is required ƒƒ Medical devices, which are equivalent to premarketed
for devices unlike those currently available on the market devices for the intended use, operation principle
– falling under new structure, new performance, new or used materials (for nonactive medical devices),
intended use, and newly developed medical devices. performance, test specification and operation
Technical documents for all Class II medical devices method, etc.
are reviewed by third parties, whereas Class III and ƒƒ Additional information has to be given for the device
IV medical devices are reviewed by MFDS. under review
ƒƒ Equivalency-notified and regularly updated by MFDS
General technical document review (TDR) ƒƒ Test report required to identify the “equivalency”
ƒƒ Devices substantially equivalent as previously issued by MFDS-registered test laboratories
approved products
ƒƒ Clinical study reports are not required Medical device testing
The test reports issued by the following laboratories
Safety and efficacy review (SER) are recognized to support the function, safety
ƒƒ Required for devices with new-to-market features – and effectiveness
new developments, new performance, new structure, ƒƒ MFDS-registered laboratories
and/or new intended use ƒƒ IEC-registered laboratories (CBTL)
ƒƒ Significant difference affecting safety and effectiveness ƒƒ KOLAS-accredited laboratories (Korea Laboratory
ƒƒ Clinical study reports are essential, in addition Accreditation Scheme acc. to ISO 17025)
to TDR requirements ƒƒ GLP laboratories accredited according to OECD rules

Technical document file contains TÜV SÜD can provide IEC reports and GLP
ƒƒ Intended use (IFU) reports for MFDS registration.
ƒƒ Physical, chemical characteristics
ƒƒ Biological safety Clinical trials
ƒƒ Electromagnetic compatibility ƒƒ Required for SER products
ƒƒ Stability report (including shelf-life test) ƒƒ MFDS approval required for protocol and clinical
ƒƒ Principle of operation trial studies
ƒƒ Electrical, mechanical safety ƒƒ Clinical investigation by medical device clinical
ƒƒ Irradiation safety trial centers qualified by MFDS (GCP)
ƒƒ Function
The clinical studies performed in foreign countries are Postmarket surveillance
recognized only if: The product license holder (local manufacturer and
ƒƒ Compliance to GCP and ISO 14155 importer) has legal responsibility for the product
ƒƒ The study reports have been accepted by the health- marketing process and postmarket surveillance activities:
competent authority of OECD member countries in the ƒƒ Patient record control required for designated products
product registration process. for medical device tracking such as cardiac implant
devices, breast implants, implantable infusion devices,
Quality system regulations (KGMP) defibrillator and continuous ventilator
All medical devices are required to be manufactured ƒƒ Adverse event/safety alert reporting for adverse effect,
under GMP. Premarket GMP audit is mandatory for new safety information from PMCF and/or literature
all Class II, III and IV devices and Class I (sterile and ƒƒ Recalls in case of effects on safety, effectiveness or
measuring devices). quality defects
ƒƒ Certification of compliance to “Standards for ƒƒ Re-evaluation and re-examination
manufacturing and quality management of medical
devices“ (KGMP, similar to ISO 13485) Our service for medical device registration
ƒƒ Both, document review and site inspection conducted ƒƒ Technical document review service for all
by third-party GMP inspector organization, the audit Class II medical devices as third-party reviewer,
team accompanied by MFDS officer registered to MFDS
ƒƒ Update every 3 years ƒƒ CB report issuance for electrical/electronic
medical devices
Currently, a MFDS guideline was published on “GMP ƒƒ GLP report issuance for biocompatibility of
audit for foreign manufacturers of imported products” and body-contact medical devices
implemented with the time frame: ƒƒ Pretechnical meeting to identify the gaps
ƒƒ Class IV: from April 8, 2012 for MFDS approval
ƒƒ Class III: from 2013 ƒƒ KGMP mock inspection service
ƒƒ Class II from 2014
Your contact partner at TÜV SÜD Product Service
In case of many manufacturing sites per importer, the can provide further information.
manufacturing sites will be sampled depending on the
criteria of product risk, importing volume, PMS data, etc. Foreign Affairs
Phone: +49 89 5008-4493
The following issues are not focused during TDR/SER Email: [email protected]
processes but during the GMP audit:
ƒƒ Sterilization process validation TÜV SÜD Korea
ƒƒ Risk management file Phone: +82 2 32151-146
Email: [email protected]

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TÜV SÜD Product Service GmbH, Medical and Health Services, Ridlerstr. 65, 80339 Munich
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