| Type of Notification | regular notification |
|---|---|
| Date of Distribution | 2019.01.23 |
| 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 |
|
| Final Date of Comments | 2019.03.24 |
| 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) | https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/t/G/TBTN19/KOR808.DOCX |
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