Type of Notification
regular notification
Date of Distribution
2019.02.01
WTO Country
Agency Responsible
Ministry of Food and Drug Safety
Regions Affected
Documents are available from the Ministry Food and Drug Safety (MFDS) website (www.mfds.go.kr). Also available from: International Cooperation Office Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Chengju-si, Chungcheongbukdo, 28159 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

Newly established standard specifications for 110 Class 1 medical devices including "Endotherapy needle, general-purpose, reusable" to ensure safety and performance of medical devices

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. 2019-053 (30 January 2019)
Final Date of Comments
2019.04.02
Contact Details
Technical Barriers to Trade (TBT) Division Korean Agency for Technology and Standards (KATS) 93, Isu-ro, Maengdong-myeon, Eumseong-gun, Chungcheongbuk-do, 27737, Republic of Korea, 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
0 0 1 0 0 0