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In case of
conflict, Medical Device Act in Korean languages shall prevail.
Interested parties should refer to the original Korea texts when
definitive informaion and legal requirements for application are
needed.
operation of diagnostic X-ray system and special medical equipment, it shall be as provided in
Articles 37 and 38 of theMedical Service Act and Articles 17-3 and 17-4 of theVeterinary
License Act.
[Full text amended on January 25, 2010]
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 >
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.
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]
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>
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.
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.
This Act shall take effect after three (3) months from the date of promulgation.
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.