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 Bahrain, Kingdom of
Agência responsável Bahrain Standards & Metrology Directorate (BSDM)
Agency or authority designated to handle comments if different from above Ministry of Industry, Commerce & Tourism Kingdom of Bahrain P.O. Box 5479 Tel.: +973 17574871 Fax: +973 17530730 E-mail: bsmd@moic.gov.bh Web site: http://www.moic.gov.bh
Artigos 5.6.2 2.9.2
Covered Products Medical Devices and Accessories
Cobertura dispositivos médicos
Title, number of pages and language(s) of the notified document Technical Regulation Medical Devices and Accessories
Resumo em portugues Propõe Regulamento Técnico para dispositivos e acessórios médicos especificando os requisitos obrigatórios de segurança e qualidade estabelecidos nas normas nacionais.
Resumo original The Technical Regulation for Medical Devices and Accessories, drafted by Ministry of Industry, Commerce & Tourism in coordination with National Health Regulatory Authority (NHRA) aims to regulate the medical devices and accessories by specifying the mandatory safety and quality requirements set out in the National standards where the devices must comply. The TR ensures that the medical devices should be designed in such a way that, when used under the conditions and for the purposes intended will not compromise the clinical condition or the safety of patients, or the safety and health of users or other persons, and to facilitate market surveillance.
Objetivos Saúde Humana Requisitos da Qualidade
Documentos relevantes Draft Technical Regulation for Medical Devices & Accessories
Detalhes do contato Ministry of Industry, Commerce & Tourism Kingdom of BahrainP.O. Box 5479 Tel.: +973 17574871 Fax: +973 17530730E-mail: bsmd@moic.gov.bh

Datas importantes
  • Distribuição
    04/09/19
  • Comentários
    Até 03/11/19
  • Adoção
    To be determined
  • Vigência
    Generally six months after publication in the Official Gazette
Notificações Relacionadas