Korea Food and Drug Administration  
Public Announcement No. 2009 -106 
 
 
As proposing revisions to the ‘ Common Standards and Specifications for Biological Safety 
of Medical Devices ’, the Korea Food and Drug Administration is announcing the intent, 
reason and  key elements of the revisions in accordance with Articles 41 and 46 of the 
‘Administrative Procedures Act’  as follows , in order to notify citizen s beforehand and to 
collect public opinion . 
                                                                  
April  09, 200 9 
                                                                                                                                         
Commissioner,                                                                                                                                               
Korea Food and Drug Administration  
 
 
 
 
Proposed Public Notice for Partial Revisions to  
‘Common Standards and Specifications for  
Biological Safety of Medical Devices’  
 
1. Reason for the revisions  
 
The reason for revisions is to set the standards and specifications for talc in order to 
ensure safety when it is us ed to manufacture medical devices that come into contact with 
or are inserted into the human body, since it is possible for talc to contain asbestos, a 
cancer -causing material.  
 
2. Key Elements  
 
 Set the standards and specifications for talc to ensure safety in the case it is used for 
manufacturing medical devices that come into contact with or are inserted into the human 
body ( Appendix 1 of the Proposal).  
 
  (1) The standards and specifications specific for talc , which  is used to manufacture 
medical devices that come into contact with or are inserted into the human body, were not  
yet laid down.  
  (2) Usage of talc that is used to  manufacture medical devices that come into contact with 
or are inse rted into the human body should meet standard requirements laid down in the 
Korean Pharmacopoeia.  
  (3) Contribution to the promotion of public health  by tightening of regulations  on 
asbestos, a cancer -causing material.  3. ADDENDUM  
 
Article 1 (Date of Enf orcement)  This regulation shall take effect from the date of 
announcement.  
 
4. Presenting written opinion  
 
 Any group or individuals who have opinion(s) about the Propos al for Partial  Revisions to 
‘Common Standards and Specifications for Biological Safety of Medical Devices’ 
(Attachment) are welcome to present written opinion to  the commissioner of the Korea 
Food and Drug Administration ( CC: Medical Device Standardization Division, Address: 
194 Tongilro, Eunpyeong -gu, Seoul (Postal Code: 122 -704), Phone :  02-380-1785~6,  
Fax 02 -351-3726, e -mail: ohj55@kfda.go.kr ) by April  27th, 200 9. The written opinion 
should contain the following  item s: 
 
  A. Opinion about the propos al (Whether you are for or against it and the reasoning)  
  B. Your name (For groups, the na me of the group and name of the representative), address 
and phone number  
  C. Other references  
 
Attachment:  Notice of proposal to ‘Common Standards and Specifications for Biological 
Safety of Medical Devices’ .  
Korea Food and Drug Administration  
Public Announcement No. 2009 -106 
 
Under the provisions of Article 18 of the ‘Medical Devices Act ’, the Korea Food and 
Drug Administration hereby revise ‘Common Standards and Specifications for Biological 
Safety of Medical Devices’ (Korea Food and Drug Administrat ion, Public Notice No. 
2006 -32, Dated August 02, 2006) as follows.  
 
April 09, 2009  
                                                                                                                                                                             
Commissioner,                                                                                                                                               
Korea Food and Drug Administration  
 
 
Proposal for Partial Revisions to  
‘Common Standards and Specifications for  
Biological Safety of Medical Devices’  
 
A part of  ‘Common Standards and Specifications for Biological Safety of Medical Devices’ 
shall be revised as follow:  
 
[Appendix 1]  4.9 shall be added to Chapter 1 -4 as below.  
 
    4.9  In the case of using talc for manufacturing medical devices that come into contact 
with or are inserted into the human body usage should meet standard requirements laid 
down in the Korean Pharmacopoeia.  
 
ADDENDUM  
 
Article 1 (Date of Enforcement)  This regulation shall take effect from the date of 
announcement.  Comparison of New and Old Provisions  
------------------------------------------------------  
 
Current Provisions  Proposed Provisions  
[Appendix 1] Evaluation and Testing  
 
4. General principles applicable to 
biolog ical evaluation of medical devices  
 
4.1 ~ 4.8 (Omitted)  
 
<Added>  [Appendix 1] Evaluation and Testing  
 
4. General principles applicable to 
biological evaluation of medical devices  
 
   4.1 ~ 4.8  (The same as at present)  
 
   4.9  In the case of using talc fo r   
      manufacturing medical devices that   
      come into contact with or are inserted  
      into the human body usage should meet 
standard requirements laid down in the 
Korean Pharmacopoeia.