Korea Food and Drug Administration  
Public Announcement No. 2010 -110 
 
 
By way of  proposing  a revision to the ‘Regulation s on the Review of Technical Document ation s for 
Medical Devices  etc. ’ (Korea Food and Drug Administration Public Notice No.2009 -219, dat ed December 
30, 2009),  the Korea Food and Drug Administration is announcing the intent, reason and key elements of 
the revision in accordance with Article 46 of ‘Administrative Procedures Act’ as follows, in order to 
notify citizens beforehand and to colle ct the public opinions.  
                                                                                                                                                                          
May 03, 2010  
                                                                                                                                                            Commissioner,                                                                                                                                        
Korea Food and Drug Administration  
 
 Administrative  Notice for Proposed  Partial Revision to  
‘Regulation s on the Review of Technical Document ation s for 
Medical Devices  etc. ’  
 
1. Reason for the revision  
Current ly, medical devices made with  raw mater ials that have been proved  safe are being notified in the 
‘Regulation s on the Review of Technical Document ation s for Medical Devices  etc.’ and exempted  from 
submitting data  for biological safety evaluation . The reason for the revision is to change t his from 
notification to public announcement , aiming  at swift  product development and a reduction  in costs .   
2. Key Elements  
A. Medical devices that are exempt ed from submitting data  for biological safety evaluation will be 
publicly announced instead of being n otified (Article 7 Paragraph 1 Subparagraph 1 Item d of the 
Proposal).  
(1) At present, m edical devices made with  raw materials that have been proved  safe are being 
notified in the Attached Table 2 of the Regulations, and they are exempt ed from submitting data 
required  for biological safety evaluation. However, the process usually takes several months 
before the notification has been amended and therefore makes it difficult to be applied 
promptly.   (2) Announcing m edical devices that have been selected as subjects of exemption from biological 
safety evaluation is to improve the current system and let the relevant business parties and 
organizations to be able to apply the exemption immediately.  
3. Presenting written opinion  
 Any group or individuals who have opinion( s) about Proposed Administrative Notice for Partial Revision 
to ‘Regulation s on the Review of Technical Document ation s for Medical Devices  etc. ’ (Attachment) are 
invit ed to present written opinion (s) to the Co mmissioner of Korea Food and Drug Administratio n 
(Postal Code: 122 -704, Address: 194 Tongilro, Eunpyeong -gu, Seoul , CC: Medical Device Policy  Division, 
Phone:  02 -350-4951 , Fax : 02-350-4950 ) by May  25th, 20 10. The submission  of opinion should contain 
the following items:  
A. Opinion about th is advance  noti ce (Whether you are in favou r or against it and the reasoning)  
B. Your name (For groups, the name of the group and name of the representative), address and 
phone number  
C. Other references   
Korea Food and Drug Administration Public Notice No.2010 - 
 
Under  the pr ovision of Article 7 Paragraph 4 of the ‘Enforcement Regulations of Medical Devices Act’, 
the Korea Food and Drug Administration hereby notify the revision to the  ‘Regulation s on the Review of 
Technical Document ation s for Medical Devices  etc. ’ (Korea Food  and Drug Administration Public Notice 
No.2009 -219, dated December 30, 2009),   as follows.  
 
, 2010 
                                                                                                                                                         Comm issioner,                                                                                                                                               
Korea Food and Drug Administration  
 
 
Proposed Partial Revision to ‘Regulation s on the Review of 
Technica l Document ation s for Medical Devices  etc. ’  
 
A part of  the ‘Regulations on the Review of Technical Documentations for Medical Devices etc.’ shall be 
revised as follows:  
In the Article 1, change “ ‘Enforcement Regulations of Medical Devices Act’ “ to “Artic le 6 Paragraph 7 of 
the ‘Medical Devices Act’ and Article 5 Paragraph 5 of the ‘Enforcement Regulations of Medical Devices 
Act’ “.  
Revise the Article 3 Paragraph 1 as below and change “following Subparagraphs” in the Paragraph 2 of 
the same Article to “one  of the following Subparagraphs”.  
    Subjects of data review for technical documentations shall be medical devices applying for regulatory  
approval of manufactur ing or import ing (including approval for change s).  
 
In the proviso of Article 7 Paragraph 1 S ubparagraph 1 Item D, change “ medical devices specified in the 
Attached Table 2 “ to “ medical devices that use raw materials,  which has been announced by the 
Commissioner of Korea Food and Drug Administration“, change “ can be exempted from submitting data 
(Paragraph 3 in the Attached Table 2 is excluded)” to “ may not submit data”. In Item H 2) of the same Subparagraph, change “Attached Table 4” to “Attached Table 3”. In Paragraph 2 of the same Article, 
change “Attached Table 4” to “Attached Table 3”.  
Resci nd the Attached Table 2, and rename Attached Table 3 and Attached Table 4 to Attached Table 2 
and Attached Table 3 respectively.  
 
 
ADDENDUM  (2010.  .  .)  
 
Article 1 (Date of Enforcement)  The regulation s shall take effect from the date of announcement.  
Article 2 (Applicable  Cases ) The applications for review of technical documentations for medical devices 
that already had been submitted at the time of enforcement of this announcement shall be reviewed in 
accordance with this announcement.  
 
  
Comparison of N ew and Old Provisions  
Current  Proposal  
Article 1 (Purpose)  The purpose of this 
regulation is to stipulate details needed for 
review of technical documentations etc. for 
medical devices in accordance with the 
Article 7 Paragraph 4  of ‘Enforcement 
Regulatio ns of Medical Devices Act ’. 
 
 
 
Article 3 (Subjects to Review etc.)    The 
medical devices applying for approval to be 
manufactured or imported (including 
approval for change) shall undergo the data 
review for technical documents.  
 
 A medical device, which is applicable to 
above Paragraph 1 and falls under the 
following S ubparagraphs,  safety and efficacy 
review shall be included.  
 
Article 7 (Requirements for 
Documentations)   
  (Omitted)  
1. Data for technical documentations review  
    A. ~ C.  (Omitted)  
    D. Data for biological safety  
For medical devices and relevant par ts 
that have direct contact with or to be 
inserted into human body, or medical 
devices that have contact with blood or 
body fluid or drug that would be injected 
into human body, the following data are 
required; test items, test methods, test 
conditions, st andards, test results, test 
facilities and the person in charge for the 
test in accordance with the ‘Common 
Standards and Specifications for 
Biological Safety of Medical 
Devices’(Korea Food and Drug 
Administration Public Notice) or 
international standard ( e.g. ISO, JIS, 
ASTM) that is equivalent to or higher Article 1 (Purpose)  The purpose of this 
regulation is to stipulate details needed for 
review of technical document ations etc. for 
medical devices in accordance with the 
Article 6 Paragraph 7 of ‘Medical Devices 
Act’ and the Article 5 Paragraph 5, Article 7 
Paragraph 4 of ‘Enforcement Regulations of 
Medical Devices Act’ . 
 
Article 3 (Subjects to Review etc.)    The 
subjects of data review for technical 
documentations shall be medical devices 
applying for regulatory approval of 
manufacturing or importing (including 
approval for changes).   
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 one of the following Subparagraphs,  -----------
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 Article 7 (Requirements for 
Documentations)   
  (The same as at present ) 
1. Data for technical documentations re view  
    A. ~ C.  ( The same as at present ) 
    D. Data for biological safety  
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-----------------------------------------------------------than aforementioned Standards. 
However, medical devices specified in the 
Attached Table 2  can be exempted from 
submitting data (Paragraph 3 in the 
Attached Table 2 is excluded)  about 
biological safety if  following data w as 
submitted; a document such as an 
analysis report by which the use of 
relevant raw material can be proved, a 
supply certificate of raw material, and 
manufacturing process related data 
which can demonstrate the facts that 
only simple mach ining has been done.  
    H. Data for test standards to confirm 
performance of the product, its basis and 
actual measurement value shall be one 
of the followings.  
1) (Omitted)  
2) Data about actual measurement value 
including the contents of the Attached 
Table 4.  
  The base data specified in Paragraph 1 
Subparagraph 1 from Item C to H and in 
Paragraph 1 Subparagraph 2 from Item A to 
C shall be one of the followings. The test 
data among the  following  shall have 
matching product name, model name and 
list of raw mater ials with the ones applied 
for the review of technical documentation, 
and shall comply with the Attached Table 4 . 
However, if the test data has been more 
than 3 years since the issue date, additional 
supplement data shall be submitted to 
prove that there h ave been no changes 
since the issue date.  
 
Article 19 (Test Measures)  Test measures 
shall be entered according to the following 
subparagraphs.  
  1. Select required test items from Attached 
Table 3 , which is a list of test items for 
medical devices, by the character of the 
product based on attached documents in 
accordance with the Article 7, and record 
test standard and test method accordingly.  
 -------------------------- , medical devices that 
use raw materials,  which has been 
announced by the C ommissioner of  
Korea Food and Drug Administration 
may not submit data --------------------------
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H. Data for test standards to confirm 
performance of the product, its basis and 
actual measurement value shall be one 
of the followings.  
1) (The same as at present ) 
2) --------------------------------------------------  
------------------------------------------  Attached  
Table 3.  
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  Attached Table 3 --------------------------------------  
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Article 19 (Test Measures)  Test measures 
shall be entered according to the following 
subparagraphs.  
1.------------------------------------- Attached 
Table 2 ------------------------------ ------ --------------
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