Produtos afetados
Sistema de classificação Código Nome
HS 90 Instrumentos e aparelhos de óptica, de fotografia, de cinematografia, de medida, de controle ou de precisão; instrumentos e aparelhos médico-cirúrgicos; suas partes e acessórios.
ICS 11040 Medical equipment
Detalhes
País Korea, Republic of
Agência responsável Ministry of Food and Drug Safety
Agency or authority designated to handle comments if different from above International Cooperation Office Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Heungdeok-gu, Chengju-si, Chungcheongbuk-do, 28159 Republic of Korea Tel: (+82) 43 719-1564 Fax: (+85) 43 719-1550 Email: wtokfda@korea.kr Website: www.mfds.go.kr
Artigos 5.6.2
Covered Products Medical Devices
Cobertura dispositivos médicos
Title, number of pages and language(s) of the notified document Amendment of “Regulation on medical device group and class by group”
Resumo em portugues Propõe alteração do Regulamento Técnico sobre grupo de dispositivos médicos e classe por grupo.
Resumo original The Republic of Korea is proposing to amend the “Regulation on medical device group and class by group”. The main changes proposed are: 1) ‘Respirator, medical’ as medical device was newly classified 2) The number of software as medical devices were expanded from 8 to 90 considering clinical field
Objetivos Saúde Humana
Documentos relevantes Ministry of Food and Drug Safety Public Notice No. 2020-373 (28 August 2020)
Detalhes do contato Korea WTO TBT Enquiry PointTechnical Barriers to Trade (TBT) DivisionKorean Agency for Technology and Standards (KATS)93 Isu-ro Maengdong-myeon Eumseong-gunChungchungbuk-do 27737+(82) 43 870 5525+(82) 43 870 5682 (Fax)tbt@korea.krhttp://www.knowtbt.kr

Datas importantes
  • Distribuição
    22/09/20
  • Comentários
    Até 21/11/20
  • Adoção
    To be determined
  • Vigência
    To be determined
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