Type of Notification
regular notification
Date of Distribution
WTO Country
Agency Responsible
Ministry of Food and Drug Safety
Regions Affected
International Cooperation Office Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Chengju-si, Chungcheongbuk-do, 363-700 Republic of Korea Tel: (+82) 43 719-1564 Fax: (+85) 43 719-1550 Email: wtokfda@korea.kr
Notified Document Details
<p style="margin:2px !important;">Amendment of "Regulations on standard specification of medical devices”</p>
ICS Code
Covered Products
<p style="margin:2px !important;">Medical Devices</p>
Description of Content

The Ministry of Food and Drug Safety (MFDS) has newly established standard specifications for 'Syringe, filter', 'Needle, filter' and 'Needle, filter, reusable' to clarify the test specifications and methods for quality control of filtration performance of these products.

Objectives & Rationale
<p style="margin:2px !important;">Promoting the health and safety of patients and medical professionals</p>
Relevant Documents
  • Ministry of Food and Drug Safety Advance Notice No. 2019-031 (2019.1.18.)
Final Date of Comments
Contact Details
Technical Barriers to Trade(TBT) Division Korean Agency for Technology and Standards (KATS) 93, Isu-ro, Maengdong-myeon, Eumseong-gun, Chungcheongbuk-do, Republic of Korea, 27737 Tel.: (+82) 43 870 5525 Fax: (+82) 43 870 5682 E-mail: tbt@kats.go.kr Website: http://www.knowtbt.kr
Document Online Link (EN)
Notified Under
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