Medical Device Act

[Effective as of November 28, 2010][Act No. 10326, May 27, 2010]

CHAPTER 1. GENERAL PROVISIONS

Article 1(Purpose) The purpose of this Act is to promote the efficient administration of medical
devices and to contribute to improving the public health by stipulating regulation regarding the
manufacture, import, distribution, etc. of medical devices.
Article 2(Definitions)
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: <Amended on April 11, 2007>
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.
For the purpose of this Act, the term "technical document" means a document on the quality
of a medical device, such as, performance, safety, etc., which includes raw materials, structure,
purpose of use, instructions for use, principles of actions, cautions in use, test specifications, etc.
For the purpose of this Act, the term medical device handler means a person [1] who
deals with medical devices for business purposes and falls under any of the following Items
provided below, and has acquired a license or filed a notification under this Act or [2] who has
established a medical institution under the Medical Service Act or a veterinary center under the
Act for Veterinarian:
1. Manufacturer of medical device
2. Importer of medical device
3. Refurbisher of medical device
4. Seller of medical device
5. Renter of medical device
Article 3 (Classification and Designation)
For systematic and reasonable administration of
safety of medical device, the Commissioner of Korea Food and Drug Administration [hereinafter
referred to as KFDA Commissioner] shall classify and designate the class of a medical device
depending on purpose of use and difference in potential risk posed to the human body by use of
medical device, etc.
Necessary matters concerning the criteria and procedures for the classification and designation
of medical devices pursuant to Paragraph 1 shall be provided in the Ministerial Decree of the
Ministry of Health and Welfare. <Amended on February 29, 2008 and January 18, 2010
respectively>
Article 4 (Relationship with Other Laws) Notwithstanding this Act, regarding installation and

operation of diagnostic X-ray system and special medical equipment, it shall be as provided in
Articles 37 and 38 of the Medical Service Act and Articles 17-3 and 17-4 of the Veterinary
License Act .
[Full text amended on January 25, 2010]

CHAPTER 2 MEDICAL DEVICE COMMITTEE

Article 5 (Medical Device Committee)
The Medical Device Committee shall be established at
the Ministry of Health and Welfare to investigate and deliberate the following matters upon
request for advice from the Minister of Health and Welfare or the KFDA Commissioner:
<Amended on February 29, 2008 and January 18, 2010 respectively>
1. Matters concerning the standard specifications of medical devices;
2. Matters concerning the re-examination or re-evaluation of medical devices;
3. Matters concerning the devices subject to tracking;
4. Matters concerning the classification and designation of medical devices; or
5. Other important matters concerning medical devices
Matters concerning the organization, operation, etc. of the Medical Device Committee shall be
provided in the Presidential Decree.

CHAPTER 3. MANUFACTURE, ETC. OF MEDICAL DEVICE

SECTION 1. MANUFACTURING BUSINESS
Article 6 (Manufacturing Business License, Etc.)
A person that intends to manufacture
medical devices for business purpose shall obtain from the KFDA Commissioner a manufacturing
business license for each manufacturing site.
A person that has obtained a manufacturing business license under Paragraph 1 of this Article
(hereinafter referred to as Manufacturer) shall obtain a manufacture license or file a
manufacture notification for each product it intends to manufacture.
A person applying for a manufacturing business license under Paragraph 1 shall
simultaneously apply for product manufacture license or file product manufacture notification for
one or more products.
. <Amended on February 29, 2008 and January 18, 2010 respectively>
A manufacturer intending to obtain a product manufacture license or to file a product
manufacture notification under Paragraph 2 of this Article shall submit to the KFDA
Commissioner necessary information, such as, technical document, test reports, clinical trial
reports, etc. as determined by the Ministerial Decree of the Ministry of Health and Welfare.
<Amended on February 29, 2008>
A person falling under any of the following Items may not obtain a manufacturing business
license for medical device: <Amended March 31, 2005 and October 17, 2007>
1. A person who has a mental disorder under Item 1 of Article 3 of the Mental Health Act;
provided, however, that this shall not be applicable to a person who has been determined by

a specialized medical doctor as appropriate for a manufacturer;

2. A person who has been declaredn to be incompetent, entirely or partially, or bankrupt and
has not been reinstated therefrom;
3. A person addicted to narcotics or other toxic substances;
4. A person who has been sentenced to imprisonment without compulsary labor or heavier
punishment due to violation of this Act and has not completed such sentence or it has not
been determined not to enforce such sentence; or
5. A person whose manufacturing business license has been cancelled due to a violation of this
Act within 1 year.
Necessary matters concerning manufacturing business license under Paragraph 1 and the scope,
procedures, criteria, conditions, administration, etc. for the product license or product notification
under Paragraph 2 shall be provided in the Ministerial Decree of the Ministry of Health and
Welfare. <Amended on February 29, 2008 and January 18, 2010 respectively>
Article 7 (Conditional Approval, Etc.)
As for manufacturing business license, product
manufacture license or product manufacture notification, the KFDA Commissioner may grant
license or accept notification under the condition that the applicant will comply with Paragraph 4
of Article 6 within a specified period of time.
Necessary matters concerning the conditional approval under Paragraph 1 shall be provided in
the Ministerial Decree of the Ministry of Health and Welfare. <Amended on February 29, 2008
and January 18, 2010 respectively>
Article 8 (Re-evaluation of Newly Developed Medical Devices, Etc.)
In case that the KFDA
Commissioner determines that the device being approved needs post-market investigation on
safety and effectiveness [i] because the product is a newly developed medical device and it is
thus not substantially equivalent to a product previously approved by or notified to [KFDA] in
terms of principles of operation, performance, purpose of use, etc., or [ii] because the product
falls under an orphan device designated by the KFDA Commissioner as the number of patients
requiring such device for care is small in Korea and the device is of special value in terms of
the purpose of use, he may order, when granting product manufacture license, the device
approved under Paragraph 2 of Article 6 to be re-examined.
The manufacturer of a medical device subject to a re-examination under Paragraph 1 shall
submit an application for re-examination within a period of time set by the KFDA Commissioner
within 4 to 7 years from the date of the product manufacture license. Such application shall
include information on the results of using the device, adverse events, and other information as
determined by the Ministerial Decree of the Ministry of Health and Welfare. <Amended on
February29,2008>
Necessary matters concerning the methods, procedures, timing, etc. for the re-examination
provided by Paragraphs 1 and 2 shall be provided in the Ministerial Decree of the Ministry of
Health and Welfare.
<Amended on February 29, 2008 and January 18, 2010 respectively>
Article 9 (Re-evaluation)
The KFDA Commissioner may re-evaluate a medical device for
which product manufacture license has been granted or product manufacture notification has been
filed under Paragraph 2 of Article 6 but the Commissioner deems re-evaluation of its safety and
effectiveness necessary.

Necessary matters concerning the methods, procedures, criteria, etc. for the re-evaluation
provided by Paragraphs 1 and 2 shall be provided in the Ministerial Decree of the Ministry of
Health and Welfare.
<Amended on February 29, 2008 and January 18, 2010 respectively>
Article 10 (Approval of Clinical Trial Plan, Etc.)
A person who intends to conduct a clinical
trial on a medical device shall prepare a protocol and obtain approval therefor from the KFDA
Commissioner. An amendment to an approved protocol shall also be subject to the same process.
Notwithstanding Articles 6 and 14, an investigational device to be used for a clinical trial
approved under Paragraph 1 may be manufactured or imported.
A person who intends to conduct a clinical trial under Paragraph 1 may not select a subject
who is under the custody of a social welfare institution (hereinafter refer to as inmates)
defined by the Ministerial Decree of the Ministry of Health and Welfare, such as, a collective
care institution, except where selection of inmates is inevitable considering characteristics of
clinical investigation and such case falls into the criteria set by the Ministerial Decree of the
Ministry of Health and Welfare. <Amendment dated February 29, 2008 and January 18, 2010
respectively>
The KFDA Commissioner may order to amend or cancel an [approved] clinical trial or take
any other necessary measures if the KFDA Commissioner determines that a clinical trial
approved under Paragraph 1 has caused or may cause significant risk on public health.
A person who intends to conduct a clinical trial under Paragraph 1 shall explain to a subject
the contents of clinical trial, the compensation for health damage that may occur to subject
during the clinical trial and procedures therefor, etc. and shall obtain the consent of a subject.
A person who intends to manufacture or import an investigational device under Paragraph 2
shall manufacture or import a medical device manufactured at facilities that are in compliance
with a relevant ministerial ordiance(s) of the Ministry of Health and Welfare. <Amended on
February 29, 2008 and January 18, 2010 respectively>
Necessary matters concerning the information to be included in a clinical trial plan, the
consents of and timining and methods of a subjects consent, standards for clinical trial, etc.
under Paragraphs 1 and 5 shall be provided in the Ministerial Decree of the Ministry of Health
and Welfare. <Amended on February 29, 2008 and January 18, 2010 respectively>
Article 11 (Amendment to Approval, Etc.)
In case there is any change in the granted license
or filed notification under Paragraphs 1 or 2 of Article 6, the manufacturer shall obtain an
amended license or file an amended notification to the KFDA Commissioner.
Necessary matters concerning the procedures, standards, etc. for amended license or
notifications under Paragraph 1 shall be provided in the Ministerial Decree of the Ministry of
Health and Welfare. <Amended on February 29, 2008 and January 18, 2010 respectively>
Article 12 (Responsibility of Manufacturer)
A manufacturer shall maintain its facilities and
quality management system as provided by Paragraph 4 of Article 6 and shall also comply with
the Ministerial Decree of the Ministry of Health and Welfare regarding manufacturing, quality

management (including self-testing) or production management. <Amended February 29, 2008 and
January 18, 2010 respectively>
A manufacturer shall submit to the KFDA Commissioner report on its production of medical
devices, etc. according to the procedures set by the Ministerial Decree of the Ministry of Health
and Welfare. <Amendment dated February 29, 2008 and January 18, 2010 respectively>
The Manufacturer shall not offer money, goods, benefit, labor, entertainment, and other
economic benefits (hereafter referred to as Economic Benefits, etc.) to medical practitioners or
those who established medical institutions (including the president or director, or other employees
of a corporation), and those who are engaged in a medical institution for the purpose of sales
promotion such as encouraging the adoption or use of a Medical Device, etc., ; provided that
Economic Benefits, etc. within the scope specified by the Ministerial Decree for Health and
Welfare, such as offer of samples, support for symposiums or clinical trials, presentation of the
product, discount under the payment terms, post marketing surveillance, etc. (hereafter referred to
as Acts of Offer of Samples, Etc.), shall be excluded.<Newly added on May 27, 2010>
Article 13 (Notification of Shutdown of Business, Etc.) In case of a closure or suspension of its
manufacturing site, a re-opening of closed or suspended manufacturing site or other changes in
matters provided by the Ministerial Decree of the Minister of Health and Welfare, the
manufacturer shall notify the KFDA Commissioner thereof within 30 days of such closure,
suspension, re-opening or changes, except for a suspension for less than one month. <Amended
on February 29, 2008 and January 18, 2010 respectively >

SECTION 2. IMPORT BUSINESS

Article 14 (Import Business License)
A person who intends to import medical devices for
business shall obtain an import business license from the KFDA Commissioner.
A person who has obtained an import business license under Paragraph 1 (hereinafter referred
to as importer) shall obtain a product import license or file a product import notification for
each product it intends to import.
A person applying for an import business license under Paragraph 1 shall simultaneously
obtain a product import license or file a product import notification for one or more products.
A person intending to obtain a product import license or file a product import notification
under Paragraph 2 shall have facilities for quality testing and a quality management system in
place as set forth by the Ministerial Decree of the Ministry of Health and Welfare, except where
the Ministerial Decree of the Ministry of Health and Welfare provides otherwise. <Amended on
February 29, 2008 and January 18, 2010 respectively>
Paragraphs 5 through 7 of Article 6, Articles 7 through 9, and Articles 11 through 13 shall
apply, mutatis mutandis, to the medical devices imported under Paragraphs 1 through 4 and their
importers. In this case, "manufacture" shall be replaced with "import" and "manufacturer" with
"importer," respectively.

SECTION 3. REFURBISHING BUSINESS

Article 15 (Notification of Refurbishing Business)

A person who intends to refurbish medical

devices for business (hereinafter referred to as Refurbisher) shall submit a refurbishing business
notification to the KFDA Commissioner as provided by the Ministerial Decree of the Ministry of
Health and Welfare, except where a person who has obtained a product manufacture license, etc.
under Paragraph 2 of Article 6 refurbishes its own products. <Amended on February 29, 2008
and January 18, 2010 respectively>
A person intending to file a notification under Paragraph 1 shall have facilities and a quality
management system in place as determined by the Ministerial Decree of the Ministry of Health
and Welfare. <Amended on February 29, 2008 and January 18, 2010 respectively>
Necessary matters for accepting a notification of refurnishing business under Paragraph 1,
such as, the scope of medical devices, criteria, conditions, etc. shall be determined by the
Ministerial Decree of the Ministry of Health and Welfare. <Amended on February 29, 2008 and
January 18, 2010 respectively>
Paragraph 6 of Article 6 and Articles 11 through Article 13 shall apply, mutatis mutandis, to
the notification under Paragraph 1. In this case, "manufacture" shall be replaced with "refurbish"
and "manufacturer" with "refurbisher," respectively.

SECTION 4. SALE AND RENTAL BUSINESSES

Article 16 (Notification of Sale Business, Etc.)
A person who intends to sell medical devices
for business (hereinafter referred to as "Seller") or a person who intends to rent medical devices
for business (hereinafter referred to as "Renter") shall submit for each place of business a sale
business notification or a rental business notification to the city mayor, Goon-governor or
Gu-governor of the place wherein its business is located in accordance with the Ministerial
Decree of the Ministry of Health and Welfare.<Amended on February 29, 2008 and January 18,
2010 respectively>
A notification under Paragraph 1 may be exempt in any of the following cases: <Amended
on April 6, 2007 and February 29, 2008 and January 18, 2010 respectively>
1. A manufacturer or importer of medical devices sells or rents the medical devices it has
manufactured or imported to a medical device handler;
2. A seller who has filed a sale business notification under Paragraph 1 engages in rental
business ;
3. A pharmacy or a drug wholesaler sells or rents medical devices;
4. A person sells contraceptive devices designated by the Ministerial Decree of the Ministry of
Health and Welfare, or self-diagnostic devices to be used at a place other than medical
institution.
Paragraph 6 of Article 6, Article 11 and Article 13 shall apply, mutatis mutandis, to the
notification under Paragraph 1. In this case, "manufacture" shall be replaced with "distribute or
rent" and "manufacturer" with "distributor or renter," respectively.
Article 17 (Compliance by Seller, Etc.)
A person who may sell or rent medical devices under
this Act shall comply with the applicable provisions regarding the methods for quality assurance
at its business place and other measures to maintain orderly sales as provided in the Ministerial
Decree of the Health and Welfare.
The seller or renter of medical devices shall not offer any Economic Benefits, etc. to medical

practitioners or those who established medical institutions (including the president or director, or
other employees of a corporation), and those who are engaged in a medical institution for the
purpose of promoting distribution or rent such as encouraging the adoption or use of a Medical
Device, etc.; provided that Economic Benefits, etc. within the scope specified by the Ministerial
Decree for Health, Welfare and Family Affairs, such as Acts of Offer of Samples, Etc., shall be
excluded.
[Full text amended on May 27, 2010]

CHAPTER 4. HANDLING OF MEDICAL DEVICES, ETC.

SECTION 1. STANDARDS
Article 18 (Standard Specifications) If quality standards for certain medical devices are deemed
necessary, the KFDA Commissioner may set the standard specifications for such devices
including scope of application, appearance or structure, test specifications, labeling, etc.

SECTION 2. LABELING AND ADVERTISEMENT

Article 19 (Labeling on Containers, Etc.) The following information shall be labeled on a
container or wrapper of a medical device, except for a container or a wrapper designated
otherwise by the Ministerial Decree of the Ministry of Health and Welfare: <Amended on
February 29, 2008 and January 18, 2010>
1. The business name and address of the manufacturer or importer;
2. The source of manufacture (the country of manufacture and the name of the manufacturer)
for imported devices;
3. Product name, type name (model name), product license (notification) number;
4. Manufacturing lot number and year, month and date of manufacture; and
5. Weight or packing unit
Article 20 (Labeling on Outside Package, Etc.) If the information labeled on a container or
wrapper of a medical device under Article 19 is covered by outer containers or wrappers, the
same information shall be labeled on such outer containers or packages.
Article 21 (Labeling on Package Insert) A package insert of a medical device shall contain the
following items: <Amended on February 29, 2008 and January 18, 2010 respectively>
1. How to use and precautions in use;
2. Information on check/repair, if check/repair is necessary;
3. Information determined by the KFDA Commissioner for labeling under Article 18; and
4. Other information determined by the Ministerial Decree of the Ministry of Health and
Welfare.
Article 22 (Cautions in Labeling) The information provided under Articles 19 through 21 shall be
labeled in a place enabling an easier identification than other characters, statements, illustrations
or drawings. It shall also be labeled accurately in Korean using terms easy to read and easy to
understand as provided in the Ministerial Decree of the Ministry of Health and Welfare.
<Amended on February 29, 2008 and January 18, 2010 respectively>
Article 23 (Prohibited Labeling, Advertising, Etc.)
The following Items may not be labeled on
the container, wrapper, package or package insert of a medical device:

1. Fraudulent or misleading claim;

2. Performance, efficacy or effectiveness that have not been product-licensed, etc. under ;or
3. Directions for use or duration of use that may cause risk to the public health.
No person may advertise any of the following Items in relation to the advertisement of
medical devices: <Amended on October4, 2006>
1. Fraudulent or exaggerated advertisement concerning name of a medical device, its
manufacturing methods, performance, efficacy, effectiveness, or principles of operation;
2. Advertisement making use of an article that is likely to lead to a misunderstanding that
medical doctors, dentists, oriental medicine doctors, veterinarians or other persons have
guaranteed the performance, efficacy or effectiveness of the medical device;
3. Advertisement making use of suggestive articles, photos, drawings or other suggestive
materials about the performance, efficacy or effectiveness of a medical device;
4. Advertisement of a medical device suggesting abortion or using obscene documents or images
;
5. Advertisement of a name, manufacturing methods, performance, efficacy and effectiveness of
a medical device that has not been product-licensed or product-notified under; or
6. Advertisement that has not been reviewed pursuant to Paragraph 1 of Article 23-2 or that is
different from what has been reviewed.
Necessary matters needed for labeling and advertisement scope of a medical device, etc.
under Paragraphs 1 and 2 of this Article shall be provided in the Ministerial Decree of the
Ministry of Health and Welfare. <Amended on February 29, 2008 and January 18, 2010
respectively>
Article 23-2 (Review of Advertisement)
A person who intends to advertise a medical device
shall submit an advertising material for a review by the KFDA Commissioner in accordance with
the criteria, methods, and procedure for a review set forth by the KFDA Commissioner.
The KFDA Commissioner may delegate the review works under Paragraph 1 to an
organization designated by the Ministerial Decree of the Ministry of Health and Welfare.
<Amended on February 29, 2008> [Newly added on October 4, 2006]

SECTION 3. HANDLING
Article 24 (General Prohibitions)
No person may sell, rent, give or use a medical device that
has not been product-licensed or product-notified under Paragraph 2 of Article 6 or Paragraph 2
of Article 14. Nor may any person manufacture, import, refurbish, store, or display such medical
device for the purpose of refurbishing, selling, renting, giving or using.
A medical device falling under any of the following Items may not be manufactured,
imported, distributed or rented: <Amended on October 4, 2006>
1. A medical device that is different from what has been product-licensed or product-notified
under Paragraph 2 of Article 6 or Paragraph 2 of Article 14;
2. A medical device that is, in its entirety or partially, filthy or made of materials that are
contaminated with microbes, decomposed or decayed;
3. Other medical devices that have been ordered by the KFDA Commissioner, city mayor,
Goon-governor, or Gu-governor to be destroyed, use-suspended or license-revocated pursuant to
Articles 30 through 32 due to the harm that has been or may be caused to the public health.

When refurbishing a medical device, a refurbisher may not alter the performance, structure,
the rated specifications, appearance, dimensions, etc. of a medical device that has been licensed
or notified under Paragraph 2 of Article 6 or Paragraph 2 of Article 14.
When a person who has established a medical institution or a veterinary center uses a
medical device, he may not modify or alter a medical device differently from what has been
licensed or notified under Paragraph 2 of Article 6 or Paragraph 2 Article 14.
A refurbisher, seller, or renter may not refurbish, sell, or rent a medical device falling under
any Item below, or may not store or display the same for the purposes of refurbishing, selling
or renting: <Amended on October 4, 2006>
1. A medical device that has been manufactured, imported or refurbished differently from what
has been licensed or notified under Paragraph 2 of Article 6, Paragraph 2 of Article 14 or
Paragraph 1 of Article 15; and
2. A medical device violating Paragraph 1 of Article 23.
A person who has established a medical institution may not use for clinical trial a medical
device that has not been approved for clinical trial by the KFDA Commissioner under Article
10.
No person may mark on the wrapper, package or package insert of an article that is not a
medical device any indication that may mislead to a perception that such product delivers
performance, efficacy, or effectiveness similar to those of a medical device, or make such
advertisement. Nor may a person sell or rent, or store or display for the purposes of selling or
rental, such non-medical-device products that are marked or advertised as a medical device.

Chapter 5. MANAGEMENT
Article 25 (Medical Devices Subject to Tracking)
The KFDA Commissioner may designate a
medical device subject to tracking if it falls under any Item below and its adverse side effects
or defects may cause fatal risk to the human body, necessitating tracking (hereinafter referred to
as Medical Device Subject to Tracking):
1. A medical device intended to be implanted in the human body for a year or a longer period
of time; or
2. A life-sustaining medical device that may be used outside medical institutions.
Necessary matters concerning designation, criteria for administration, etc of a Medical Device
Subject to Tracking under Paragraphs1 shall be provided in the Ministerial Decree of the
Ministry of Health and Welfare. <Amended on February 29, 2008 and January 18, 2010
respectively>
Article 26 (Documentation and Retention of Records, Etc.)
A manufacturer, importer, seller,
renter, or refurbisher of a Medical Device Subject to Tracking (hereinafter referred to as
handler in this Article) shall document and retain records of manufacturing, selling (including
purchase), rent, or refurbishing of such Medical Device Subject to Tracking. A person using a
Medical Device Subject to Tracking (hereinafter referred to as user in this Article), who has
established a medical institution or who is a medical doctor, an oriental medicine doctor, or a
dentist, etc. working at a medical institution, shall document and retain records so that the
patients who use such medical devices can be tracked.

A handler or user may not refuse, without justifiable reasons, an order of the KFDA
Commissioner such as order for submission of records, etc.
Necessary matters concerning documentation and retention of records, etc. under Paragraph 1
shall be provided in the Ministerial Decree of the Ministry of Health and Welfare. <Amended on
February 29, 2008 and January 18, 2010 respectively>
Article 27 (Management of Adverse Events, Etc.)
A medical device handler shall report
immediately to the KFDA Commissioner when they have become aware during use of a medical
device of an occurrence or risk to occur of a death or any serious adverse side effects to human
body and shall maintain such records.
A manufacturer, importer, refurbisher, seller or renter of a medical device (hereinafter referred
to as manufacturer, etc.) shall immediately recall or take actions necessary to recall a medical
device when they have become aware that the medical device has caused or is likely to cause
harm to human body due to defective quality, etc. In such case, the manufacturer or importer
shall establish a plan for recall considering the adverse effects to human body, etc. in accordance
with the Ministerial Decree of the Minister of Health and Welfare and report it to the KFDA
Commissioner in advance. <Amended on December 26, 2008 and January 18, 2010 respectively>
Upon receipt of a recall plan under the latter part of Paragraph 2, the KFDA Commissioner
may order the manufacturer or importer to make a public announcement of its recall plan.
<Newly added on December 26, 2008>
In case that the manufacturer, etc. has diligently implemented a recall or measures necessary
to a recall under Paragraph 2, the KFDA Commissioner, governor of special autonomous
province, city mayor, Goon-governor, or Gu-governor may reduce or exempt the administrative
sanctions under Article 32. According to a ministerial ordinance of the Ministry of Health and
Welfare, <Newly added on December 26, 2008 and January 18, 2010 respectively>
Necessary matters concerning the procedures for and contents of adverse side effects reporting
under Paragraph 1, the criteria, procedures and methods for recall and information that should be
included in a recall plan under Paragraph 2 and the methods for public announcement, etc. under
Paragraph 3 shall be provided in the Ministerial Decree of the Ministry of Health and Welfare.
<Newly added on December 26, 2008 and January 18, 2010 respectively> [Title amended on
December 26, 2008]

Chapter 6. SURVEILLANCE
Article 28 (Report, Inspection, Etc.)
If deemed necessary, the KFDA Commissioner, city
mayor, Goon-governor, or Gu-governor may have a medical device handler submit necessary
reports, or have relevant government officials visit medical institutions, factories, warehouses,
stores, offices or any other places handling medical devices for business and inspect the
aforementioned facilities, related files, documents, or any other relevant materials, question
relevant personnel, or collect an article which is suspected to fall under Paragraph 1 of Article
30 or sample necessary for quality test of a medical device, in a minimum quantity to the extent
necessary for test.

A government official who intends to conduct visit, inspection, questioning or collection under
Paragraph 1 shall carry and present to the relevant person an official mark evidencing her/his
authorities.
Necessary matters concerning the authority, scope of duty, and official mark under Paragraphs
1 and 2 shall be provided in the Ministerial Decree of the Ministry of Health and Welfare.
<Amended on February 29, 2008 and January 18, 2010 respectively>
Article 29 (Order for Testing) In case that the KFDA Commissioner deems that a medical device
is likely to cause a harm to the public health, the KFDA Commissioner may order the relevant
medical device handler to have such medical device tested by a test laboratory registered with
KFDA..
Article 30 (Order for Destroy, Etc.)
The KFDA Commissioner, city mayor, Goon-governor, or
Gu-governor may order a manufacturer, etc. to recall, destroy in a manner to prevent risk to the
public health or take other measures on, a medical device that has been sold, stored, displayed,
manufactured or imported in breach of Article 24, or one of which use is likely to incur serious
harm or fatal impact on the public health. <Amended on December 26, 2008>
In the event that a person who has received an order pursuant to Paragraph 1 has not
implemented the order, or in case of emergency in the public health, the KFDA Commissioner,
city mayor, Goon-governor, or Gu-governor may order relevant government officials to destroy
the pertinent articles, or take any other necessary measures such as boxing or sealing.
Paragraph 2 of Article 28 shall apply, mutatis mutandis, in case of Paragraph 2.
Article 31 (Order for Cease of Use, Etc.) In case that a medical device has failed in quality
testing conducted under Article 29 or a device is alleged to fall under Paragraph 1 of Article
30, the KFDA Commissioner, city mayor, Goon- governor, or Gu-governor may order a party
opening a medical institution or veterinary centers to discontinue the use of a medical device, to
refurbish it or take any other necessary actions in case that,
Article 32 (Cancellation, Etc. of License and Suspension of Business)
In case that a
manufacturer etc. falls under any of the Items below, the KFDA Commissioner (as to
manufacturer, importer or refurbisher of a medical device) or city mayer, Goon-governor or
Gu-governor (as to seller or renter of a medical device) may order cancellation of business
license, shutdown of business place, ban on manufacture, import, selling, or suspension of
business in its entirety or partially within a period of time set forth in the Ministerial Decree of
the Ministry of Health and Welfare. However, in case of Item 4 below, if there is no fault on a
manufacturer or importer and if it is considered that the purpose of license or notification can be
achieved by alteration of structure or raw materials of such medical device, only an order for
alteration may be issued:<Amended on February 29 and 2008, December 26, 2008 and January
18, 2010 and May 27, 2010 respectively>
1. In case of any of Items 1 through 4 of Paragraph 6 of Article 6;
2. When existence of matters falling under Item 5 of Paragraph 6 of Article 6 have been
confirmed;
3. When conditions under Paragraph 1 of Article 7 have not been fulfilled;
4. When safety and effectiveness have not been established as a result of re-examination or
re-evaluation pursuant to Articles 8 and 9;
4-2. When Economic Benefits, etc. are offered in violation of the provisions of Paragraph 3 of

Article 12 (including the case applied mutatis mutandis in Paragraph 5 of Article 14) or
Paragraph 2 of Article 17
5. In case of violation of this Act or any order issued under this Act;
6. When a medical device that has caused or is likely to cause harm to the public health or
has been determined not to perform [as intended] or provide efficacy and effectiveness
manufactured, imported, sold, refurbished or rented;
7. When the occurrence of an adverse side effect has not been reported or records therefor
have not been maintained in breach of Paragraph 1 of Article 27; or
8. When a recall or measures necessary for a recall have not been taken or a recall plan has
not been reported in breach of Paragraph 2 of Article 27.
Paragraph 1 shall also apply to a manufacturer, importer, or refurbisher that has become
incompliant with Paragraph 1 of Article 12 (including cases where Paragraph 1 of Article 12
applies, mutatis mutandis, pursuant to Paragraph 5 of Article 14 and Paragraph 4 of Article 15).
Criteria for an administrative measure under Paragraphs 1 and 2 shall be provided in the
Ministerial Decree of the Ministry of Health and Welfare. <Amended on February 29, 2008 and
January 18, 2010 respectively>
Article 33 (Administrative Sanction Fine)
In case that a medical device handler falls under
Paragraphs 1 or 2 of Article 32, if the KFDA Commissioner, city mayor, Goon-governor or
Gu-governor determines that suspension of business is likely to cause serious inconvenience to
medical device users or there is certain special reason, he may impose, in accordance with the
Presidential Decree, an administrative sanction fine up to fifty (50) million Won in lieu of
business suspension to the extent that such measure does no harm to the public health.
Necessary matters concerning determination of an amount of an administrative sanction fine
depending on the type and degree of violation and collection method, etc. under Paragraph 1
shall be provided in the Presidential Decree.
If necessary to collect the administrative sanction fine imposed, the KFDA Commissioner, city
mayor, Goon-governor, or Gu-governor may request in writing the head of a competent tax
office to provide information relating to taxation, providing the following information. <Newly
added on January 3, 2007>
1. Personal information of tax payer
2. Purpose of use
3. Information relating to sales revenue that is used as a basis for imposing an administrative
sanction fine
In case that the party responsible for paying the administrative sanction fine under Paragraph
1 has not paid it in time, the KFDA Commissioner, city mayor, Goon-governor or Gu-governor
may cancel the imposition of an administrative sanction fine imposed pursuant to Paragraph 1 in
accordance with the Presidential Decree and may suspend, instead, the business operation
pursuant to Paragraphs 1 or 2 of Article 32 or collect the administrative sanction fine according
to the procedures for collection of unpaid national or local taxes.. However, In case that
suspension of business operation is impossible due to close-down of business pursuant to Article
13, the administrative sanction fine shall be collected in accordance with the procedures for
collection of unpaid national or local taxes. <Amended on January 3, 2007>
The administrative sanction fine collected under Paragraphs 1 and 4 shall belong to the

national treasury or the local government to which the collecting agency belongs. <Amended on
January 3, 2007>
Article 34 (Hearing) When intending to issue an order to cancel a license, shutdown a business
place of, ban manufacturing, importing or selling of a medical device, suspend a business
operation in its entirety or partially, under Article 32, the KFDA Commissioner, city mayor,
Goon-governor or Gu-governor shall hold a hearing..
Article 35 (Medical Device Surveillance Officer)
For fulfillment of the duties under Paragraph
1 of Article 28 and Paragraph 2 of Article 30, medical device surveillance officers shall be
deployed at KFDA, cities, Goons or Gus (hereinafter, autonomous Gus).
The medical device surveillance officers under Paragraph 1 shall be appointed by the KFDA
Commissioner, city mayor, Goon-governor or Gu-governor among the public officials of KFDA,
cities, Goons or Gus.
Necessary matters concerning the qualification, appointment, and work scope of medical
device surveillance officers under Paragraphs 1 and 2 shall be provided in the Ministerial Decree
of the Ministry of Health and Welfare. <Amended on February 29, 2008 and January 18, 2010
respectively>

CHAPTER 7. SUPPLYMENTARY PROVISIONS

Article 36 (Research and Development to Advance Medical Device Industry) The KFDA
Commissioner may delegate to the Korea Health Industry Development Institute, which has been
established pursuant to the Act on Korea Health Industry Development Institute, the mission of
establishment of infrastructure for medical device quality evaluation, support for standardization of
medical device specification, and research and development projects for development of the
medial device industry, and provide financial supports necessary therefor.
Article 37 (Delegation or Entrustment of Authorities)
The KFDA Commissioner may partially
delegate its authority under this Act to head of local food and drug administration, the mayor of
the special metropolitan government, the mayor of the metropolitan city, the provincial governor,
the governor of the special autonomous province, city mayors, Goon-governor, Gu-governor or
director of public health center in accordance with the Presidential Decree. <Amended on March
17, 2010>
The KFDA Commissioner may entrust part of its test works under Article 29 to corporate
persons or organizations that perform testing and inspection on medical devices in accordance
with the Presidential Decree.
Article 38 (Protection of Submitted Information)
With respect to information submitted
pursuant to Articles 6 through 9, 11 or 14, if the person who has submitted such information
requests in writing for protection of such information, the KFDA Commissioner may not disclose
such information, except where disclosure is deemed necessary for the sake of public interest.
A person who has reviewed or examined the information for which protection has been
requested under Paragraph 1 shall not disclose any information it has acquired through such
review or examination.

Article 39 (Special Measures for Veterinary Devices) A medical device intended for exclusive
use on animals shall be administered by the Minister for Food, Agriculture, Forestry and
Fisheries, in which case, the KFDA Commissioner shall be replaced with Minister for Food,
Agriculture, Forestry and Fisheries, and the Ministerial Decree of the Ministry of Health and
Welfare with the Ministerial Decree of the Ministry for Food, Agriculture, Forestry and
Fisheries, respectively. When the Minister of Food, Agriculture, Forestry and Fisheries issues the
Ministerial Decree of Food, Agriculture, Forestry and Fisheries, however, he shall consult with
the KFDA Commissioner. <Amended on February 29, 2008 and January 18, 2010 respectively>
Article 40 (Succession to Status of Manufacturer, Etc.)
In case of death of a manufacturer,
etc., assignment of a medical device business, merger of corporate manufacturer, etc., the heir,
assignee of business or companies that have survived mergers or have been newly established as
a result of merger shall succeed to the status of the manufacturer, etc.; provided, however, that
this provision shall not apply where the assignee or the surviving or newly founded company
falls under Paragraph 6 of Article 6.
In the event that an heir succeeding to a manufacturer, etc. under Paragraph 1 of this article
come under Paragraph 6 of Article 6, he shall assign such inherited business to a third party
within six (6) months from the date of inheritance taking effect.
In the event that a manufacturer, etc. transfers its business concerning licensed or notified
medical device, the transferee manufacturer, etc. shall succeed to the status of the manufacturer,
etc. regarding the license or notification of the respective medical device.
Article 41 (Renewal of License or Notification) A manufacturer, etc. of a medical device shall
renew his license or notification in accordance with the Ministerial Decree of the Ministry of
Health and Welfare.<Amended on February 29, 2008 and January 18, 2010 respectively>
Article 42 (Fees) A person falling under any of the following Items below shall pay a fee as
provided in the Ministerial Decree of the Ministry of Health and Welfare. <Amended on
February 29, 2008 and January 18, 2010 respectively>
1. A person who intends to obtain a license or file a notification under this Act;
2. A person who intends to modify the contents of license or notification under this Act; and
3. A person who intends to have his advertisement reviewed in accordance with Paragraph 2 of
Article 23
[Full text amended on October 4, 2006]

CHAPTER 8. PENALTY
Article 43 (Penalty)
A person who has violated Paragraph 1 of Article 24 shall be subject to
imprisonment up to five (5) years or a fine up to twenty (20) million Won.
The penalties under Paragraph 1 of this Article may be imposed in parallel.
Article 44 (Penalty)
A person who falls under any of the following Items shall be subject to
imprisonment up to three (3) years or a fine up to ten (10) million Won <Amended on October
4, 2006>
1. A person who has breached Paragraphs 1, 3, 5 and 6 of Article 10, Paragraph 1 of Article
11 (including chases where applied, mutatis mutandis, under Paragraph 5 of Article 14 and

Paragraph 4 of Article 15), Paragraph 1 of Article 12, Paragraph 1 of Article 16, Paragraphs
1 and 2 of Article 23, Paragraphs 2 through 7 of Article 24 or Paragraph 2 of Article 38
2. A person who refused, impeded or evaded the activities of related public officials pursuant to
Paragraph 2 of Article 30 such as destruction, boxing, sealing or other necessary measures.
The penalties under Paragraph 1 may be imposed in parallel.
Article 44-2(Penalty) A person who violated the provisions of Paragraph 3 of Article
12(including the case applied mutatis mutandis in Paragraph 5 of Article 14) or Paragraph 2 of
Article 17 shall be subject to a sentence of 2 years of imprinsonment or a fine up to thirty
million won.
[Newly added on May 27, 2010]
Article 45 (Penalty) A person falling under any of the followings Items shall be subject to a
fine up to five (5) million Won: <Amended on October 4, 2006 and May 27, 2010 relatively>
1. A person who has violated Paragraph 2 of Article 12, Paragraph 1 of Article 17, Articles 19
through Article 22, Paragraphs 1 and 2 of Article 26, or Paragraph 1 of Article 27; and
2. A person who has refused, impeded or evaded visit, collection or closure, or any other
actions by responsible public officials pursuant to Paragraphs 1 of Article 28 or Paragraphs 1
and 2 of Articles 32.
3. A person who has not complied with order for inspection, destruction, suspension of use,
suspension of business, etc., pursuant to Article 29, Paragraph 1 of Article 30, Article 31 or
Paragraphs 1 and 2 of Article 32.
Article 46 (Parallel Punishments) In the event that a representative of a corporation, or an agent
or servant, or employee of an individual or a corporation has committed violations under Articles
43 through Article 45 in connection with the business of such individual or corporation, the
individual or the corporation shall also be subject to a fine under relevant provisions in parallel
with punishment of the person who has actually committed such violation, except where such
corporation or individual has not neglected significant caution and supervision of the service to
prevent the violation.
[Full text amended on March 17, 2010]
Article 47 (Administrative Default Fine)
A person who has failed to notify business closure
or renew a license or notification in violation of Article 13 (including cases where applied,
mutatis mutandis, pursuant to Paragraph 5 of Article 14, Paragraph 4 of Article 15 and
Paragraph 3 of Article 16) or Article 41 shall be subject to an administrative default fine up to
one (1) million Won.
The administrative default fine under Paragraph 1 of this Article shall be imposed and
collected by the KFDA Commissioner, city mayors, Goon-governors or Gu-governors (hereinafter
referred to as "Levying Authority") in accordance with the Ministerial Decree of the Ministry of
Health and Welfare. <Amended on February 29, 2008 and January 18, 2010 respectively>
A person who has an objection to the imposition of administrative default fine under
Paragraph 2 of this Article may file a petition with the respective Levying Authority within
thirty (30) days from the date of receiving an imposition notice.
In the event a person on whom administrative default fine has been imposed pursuant to
Paragraph 2 of this Article has filed a petition under Paragraph 3 of this Article, the Levying

Authority shall refer such petition to a competent court, which shall adjudicate the case in
accordance with the Act on Procedures for Non-adversary Actions.
In the event a person has not paid an administrative default fine without having filed a
petition within the period of time set forth in Paragraph 3 of this Article, such administrative
default fine shall be collected in accordance with the procedures for collection of unpaid national
or local taxes.

ADDENDUM<No. 6909, May 29, 2003>

Article 1 (Effective Date) This Act shall take effect after one (1) year from the date of
promulgation.
Article 2 (Transitional Measures on Licenses, etc.) Medical device manufacturing business
licenses, product manufacture licenses, product import license, product manufacture notifications,
product import notification or medical device selling business notifications granted or filed under
the previous Pharmaceutical Affairs Act as of this Act taking effect shall be deemed to have
been granted or reported under this Act.
Article 3 (Transitional Measures on Import Business License and Refurbish Business Notification)
A person who was engaging in the business of importing, refurbish, or renting medical devices
prior to the effective date of this Act, shall comply with Articles 14 or 17 within one year from
the effective date of this Act.
Article 4 (Transitional Measures on Public Notice, Administrative Action, Order, Designation and
On-going Action)
Any public notice, administrative action, order, designation and any other acts by administrative
authorities, or applications, notifications, and any other acts toward administrative authorities
under the Pharmaceutical Affairs Act prior to the effective date of this Act shall be deemed as
corresponding acts by or toward administrative authorities under this Act.
Article 5 (Transitional Measures on Penalty) The Pharmaceutical Affairs Act shall apply to the
imposition of a penalty or an administrative fine for violations of the Pharmaceutical Affairs Act
committed prior to the effective date of this Act.
Article 6 (Amendments to Other Laws)
The Pharmaceutical Affairs Act shall be amended as
follows:
The drugs, quasi-drugs, and medical instruments in Paragraph 1 of Article 2 shall be amended
to the drugs and quasi-drugs and Paragraph 9 of the same Article shall be deleted.
The drugs and medical instruments in Paragraph 1 of Article 26 shall be amended to drugs,
and the drugs and quasi-drugs or medical instruments in Paragraph 5 of the same Article shall
be amended to drugs or quasi-drugs, and the drugs or medical instruments in Paragraph 6 of
the same Article shall be amended to the drugs.
The drugs or medical instruments in Paragraph 1 of Paragraph 4 of Article 26 shall be
amended to the drugs, and the drugs and medical instruments in Paragraph 5 of the same
Article shall be amended to the drugs.
The manufacturing business of drugs et al. in Paragraph 1 of Article 27 shall be amended to
the manufacturing business of drugs.
The manufacturer of the quasi-drugs who manufactures only the medical instruments or
products that correspond to Item 1 of Paragraph 7 of Article 2 in Paragraph 3 of Article 29

shall be amended to the manufacturer of the quasi-drugs who manufactures only the products
that correspond to Item 1 of Paragraph 7 of Article 2, and Article 42 shall be deleted.
The quasi-drugs or medical instruments in Paragraph 2 of Article 44 shall be amended to the
quasi-drugs.
Section 5(Article 60 and Article 61) shall be deleted.
The drugs or medical instruments in Paragraph 4 of Article 63 shall be amended to the
drugs.
The drugs or medical instruments in Paragraph 1 of Article 69 shall be amended to drugs,
respectively.
The drugs and quasi-drugs or medical instruments in Item 1 of Paragraph 6 of Article 72
shall be amended to the drugs or quasi-drugs.
"Paragraph 2 of Article 41, Paragraph 1 of Article 42, Article 54 or Article 63 in Paragraph 1
of Article 76 shall be amended to "Paragraph 2 of Article 41, Article 54 or Article 63.
"Article 57 (including cases where applied, mutatis mutandis, under Article 59), Article 58 or
Article 60" in Item 1 of Article 77 shall be amended to "Article 57 (including cases where
applied, mutatis mutandis, under Article 59) or Article 58".
The Act on Special Measures for the Deregulation of Corporate Activities shall be amended
as follows:
The title of Article 55 "(Relaxation of the Regulation of the Medical Instrument Products
Subject to Testing)" shall be amended to "(Review on the Medical Instrument Products Subject
to Prior Testing)", and in the same article, the "medical instrument" in Paragraph 9 of Article 2
of the Pharmaceutical Affairs Act" shall be amended to the "medical device as determined in
Paragraph 1 of Article 2 of the Medical Device Act", and the "Regulation of Paragraph 1 of
Article 31 of the Pharmaceutical Affairs Act" shall be amended to the "Regulation as determined
in Paragraph 1 of Article 12 of the Medical Device Act".
The Basic Law for Health and Medical Field shall be amended as follows:
The foods, drugs, medical instruments, and cosmetics in Paragraph 3 of Article 4 shall be
amended to the foods, drugs, medical devices, and cosmetics.
The Health and Medical Service Technology Promotion Act shall be amended as follows:
The medical instrument in Item 2 of Paragraph 1 of Article 2 shall be amended to the
medical device, and Paragraph 3 of the same article shall be dealt with as follows:
The medical device as determined in Item 1 of Paragraph 1 refers to the definition
determined in Paragraph 1 of Article 2 of the Medical Device Act.
The Act on the Public Health & Environment Research Institute shall be amended as follows:
The drugs, quasi-drugs, cosmetics, medical instruments and hygienic instruments under the
Pharmaceutical Affairs Act in Item 2 of Paragraph 1 of Article 5 shall be amended to the
drugs/quasi-drugs under the Pharmaceutical Affairs Act, cosmetics under the Cosmetics Act, and
medical devices under Medical Device Act.
The Specialized Credit Financial Business Act shall be amended as follows:
The title Special Provision of the Pharmaceutical Affairs Act in Article 31 shall be amended
to the Special Provision of the Medical Device Act, and the medical instrument in Paragraph
1 of the same article shall be amended to the medical device, and Paragraph 3 of Article 34
of the Pharmaceutical Affairs Act shall be amended to Paragraph 4 of Article 14 of the
Medical Device Act, the medical instrument in Paragraph 2 of the same article shall be

amended to the medical device, and Article 42 of the Pharmaceutical Affairs Act shall be
amended to Article 16 of the Medial Device Act.
The Act on Medical Technicians shall be amended as follows:
Article 29 shall be as follows:
Article 29 (Relationshi with Other Laws) Articles 16 and 32 of the Medical Device Act shall
not apply to the registration, cancellation, etc, of opticians business under this Act.
The Radio-Communications Act shall be amended as follows:
Item 7 of Paragraph 1 of Article 57 shall be amended as follows:
7. The medical device licensed under the Medical Device Act
The Act on the Korea Health Industry Development Institute shall be amended as follows:
The foods, food additives, drugs, and medical instruments in Paragraph 4 of Article 6 shall
be amended to the foods, food additives, drugs, and medical devices.

ADDENDUM (Debtor Rehabilitation and Bankruptcy Act)

<No. 7428, March 31, 2005>
Article 1 (Effective Date) This Act shall take effect after one (1) year from the date of
promulgation.
Articles 2 through Article 4 (omitted)
Article 5 (Amendment to Other Laws)
through <91> (omitted)
<92> Medical Device Act shall be amended as follows:
The bankrupt in Item 2 of Paragraph 6 of Article 6 shall be amended to the party that has
been declared bankrupt.
<93> through <145> (omitted)
Article 6 (omitted)

ADDENDUM <No. 8037, October 4, 2006>

(Effective Date) This Act shall take effect after six (6) months from the date of promulgation
(Application to the Review of Advertising) The amended provisions in Paragraph 2 of Article
23 shall apply to medical device advertisements made after this Act has come into effect.

ADDENDUM<No. 8202, January 3, 2007>

(Effective Date) This Act shall take effect after six (6) months from the date of
promulgation.
(Application to Imposition of Administrative Fine) The amended provisions in Paragraph 4 of
Article 33 shall apply to a person on whom administrative fine is imposed after this Act has
come into effect.

ADDENDUM <No. 8335, April 06, 2007>

This Act shall take effect after three (3) months from the date of promulgation.

ADDENDUM (Medical Service Act)

<No. 8366, April 11, 2007>
Article 1 (Effective Date) This Act shall take effect from the date of promulgation. <Proviso
omitted>
Articles 2 through 19 (omitted)
Article 20 (Amendment to Other Laws). Paragraphs

through

(omitted)

The Medical Device Act shall be amended as follows:

"Paragraph 2 of Article 32 of the Medical Act" in Article 4 shall be amended to "Article 37 of
the Medical Service Act ".
through <17> (omitted)
Article 21 (omitted)

ADDENDUM (Disabled Welfare Act) <No. 8637, April 11, 2007>

Article 1 (Effective Date) This Act shall take effect after six (6) months from the date of
promulgation.
Articles 2 through 4 (omitted)
Article 5 (Amendment to Other Laws)
through
(omitted)
The Medical Device Act shall be amended as follows:
The rehabilitation aid instrument under Article 55 of the Disabled Welfare Act as in the
proviso of Paragraph 1 of Article 2 (excluding each Item) shall be amended to disabled aid
instrument under Article 65 of the Disabled Welfare Act
through

(omitted)

Article 6 (omitted)

ADDENDUM <No. 8649, October 17, 2007>

This Act shall take effect after six (6) months from the date of promulgation.

ADDENDUM (Government Organization Act) <No. 8852, February 29,2008>

Article 1 (Effective Date) This Act shall take effect from the date of promulgation. However,
<omitted> among the laws amended pursuant to Article 6 of the Addendum, amendments
made to laws that have been promulgated prior to the effective date of this Act but have not
taken effect shall take effect from the effective date of respective law.

Articles 2 through 5 (omitted)

Article 6 (Amendment to Other Laws)
through <480> (omitted)
<481> Medical Device Act shall be amended as follows:
Ministerial Decree of the Ministry of Health, Welfare and Family Affairs in Paragraph 2 of
Article 3, Paragraphs 4, 5 and 7 of Article 6, Paragraph 2 of Article 7, the latter part of
Paragraph 2 and Paragraph 3 of Article 8, Paragraph 2 of Article 9, the main text and the
proviso of Paragraph 3, Paragraphs 6 and 7 of Article 10, Paragraph 2 of Article 11, Paragraphs
1 and 2 of Article 12, the main text of the Article 13, the main text and proviso of Paragraph
4 of Article 14, the main text of Paragraph 1 and Paragraphs 2 and 3 of Article 15, Paragraph
1 and Item 4 of Paragraph 2 of Article 16, Article 17, partial proviso other than each Item of
Article 19, Item 4 of Article 21, Article 22, Paragraph 3 of Article 23, Paragraph 2 of
Paragraph2 of Article 23, Paragraph 2 of Article 25, Paragraph 3 of Article 26, Paragraph 2 of
Article 27, Paragraph 3 of Article 28, part of the main text other than each Item of Paragraph 1
and Paragraph 3 of Article 32, Paragraph 3 of Article 35, the former part of Article 39, Article
41, parts other than each Item of Article 42, and the Ministerial Decree of the Ministry of
Health and Welfare of Paragraph 2 of Article 47 shall be amended to the Ministerial Decree
of the Ministry of Health and Welfare.
Minister of Health, Welfare and Family Affairs in Paragraph 1 of Article 5 (excluding each
Item) shall be amended to the Minister for Health and Welfare.
Ministry of Health, Welfare and Family Affairs in Paragraph 1 of Article 5 (excluding each
Item) shall be amended to the Ministry of Health and Welfare.
Ministry of Agriculture and Forestry in the former and latter part of Article 39 shall be
amended to the Ministry for Food, Agriculture, Forestry and Fisheries.
Ministerial Decree of the Ministry of Agriculture and Forestry in the former and latter part of
Article 39 shall be amended to the Ministerial Decree for the Ministry for Food, Agriculture,
Forestry and Fisheries.
<482> through <760> (omitted)
Article 7 (omitted)

ADDENDUM <No. 9185, December 26, 2008>

This Act shall take effect after six (6) months from the date of promulgation.

ADDENDUM <No. 9932, January 18, 2010>

Article 1 (Effective Date) This Act shall take effect two (2) months from the date of
promulgation. <The Proviso shall be omitted.>
Articles 2 and 3 shall be omitted.
Article 4 (Amendment to Other relevant Laws) Paragraphs
through <92> shall be omitted.
<93> Medical Device Act shall be amended in part as follows:
The Ministerial Decree of the Ministry for Health, Welfare and Family Affairs" shall be
amended to the Ministerial Decree of the Ministry for Health and Welfare in Paragraph 2 of
Article 3, Paragraphs 4, 5 and 7 of Article 6, Paragraph 2 of Article 7, the latter part of
Paragraph 2 and Paragraph 3 of Article 8, Paragraph 2 of Article 9, the main text and the
proviso of Paragraph 3, Paragraphs 6 and 7 of Article 10, Paragraph 2 of Article 11, Paragraphs
1 and 2 of Article 12, the main text of the Article 13, the main text and proviso of Paragraph

4 of Article 14, the main text of Paragraph 1 and Paragraphs 2 and 3 of Article 15, Paragraph
1 and Item 4 of Paragraph 2 of Article 16, Article 17, partial proviso other than each Item of
Article 19, Item 4 of Article 21, Article 22, Paragraph 3 of Article 23, Paragraph 2 of
Paragraph 2 of Article 23, Paragraph 2 of Article 25, Paragraph 3 of Article 26, Paragraph 2 of
Article 27, Paragraph 3 of Article 28, part of the main text other than each Item of Paragraph 1
and Paragraph 3 of Article 32, Paragraph 3 of Article 35, the former part of Article 39, Article
41, parts other than each Item of Article 42, and Paragraph 2 of Article 47.
In the sections other than each Item of Paragraph 1 of Article 5, the Minister of Health,
Welfare, and Family Affairs shall be amended to the Minister of Health and Welfare.
In the sections other than each Item of Paragraph 1 of Article 5, the Ministry for Health,
Welfare and Family Affairs shall be amended to the Ministry for Health and Welfare.
<94> through <137> shall be omitted.
Article 5 shall be omitted.

ADDENDUM (Veterinary License Act) <No.9950, January 25, 2010>

(Effective Date) This Act shall take effect on the date when one (1) year has elapsed from
the promulgation of this Act.
and

omitted

(Amendment to Other Relevant Laws) The Medical Device Act shall be amended in part.
Article 4 shall be mentioned below:
Article 4 (Relationshi with Other Laws) Despite this Act, installation and operation of diagnostic
X-ray system and special medical equipment shall be as provided in Articles 37 and 38 of the
Medical Service Act and Articles 17-3 and 17-4 of the Veterinary License Act .

ADDENDUM<No. 10129, March 17, 2010>

This Act shall take effect from the date of promulgation.

ADDENDUM<No. 10326, May 27, 2010>

This Act shall take effect after six (6) months from the date of promulgation.