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 Cheongju-si, Chungcheongbuk-do, 28159 Republic of Korea Tel: (+82) 43 719-1564 Fax: (+82) 43-719-1550 Email: intmfds@korea.kr Website: www.mfds.go.kr
Artigos 2.10.1
Covered Products Medical Devices
Cobertura dispositivos médicos
Title, number of pages and language(s) of the notified document Amendments to the "Enforcement Rule of the Medical Devices Act"
Resumo em portugues Propõe Regulamento Técnico para alterações à regra de aplicação da lei de dispositivos médicos
Resumo original The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is amending the "Enforcement Rule of the Medical Devices Act" for the following purposes: To adjust fees such as medical device licenses and examinations according to the inflation rate To increase personnel for professional reviews in response to the increase in the number of high-tech products To revise provisions on the fees for medical device approvals and reviews in order to expedite the approval and review processes
Objetivos Outros
Documentos relevantes Ministry of Food and Drug Safety Public Notice No. 2020-399 (16 September 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
    30/09/20
  • Comentários
    Até 26/10/20
  • Adoção
    To be determined
  • Vigência
    To be determined
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