ECGeneralEthicalReview object
Submission for Ethical review mandatory for
All types of medical devices
Submission to CA and EC to be performed in the following order
In parallel
Sequentially (in any order)
Additional Information
Guidance on documents that will be evaluated by CEIC Experts might be found at CEIC Website: http://www.ceic.pt/documentos-submissao
and at RNEC: https://www.rnec.pt/pt/submissao-nacional
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
National Ethics Committee
Other
Regulatory and ethics bodies involved in approval process: Competent Authority- Infarmed; National Ethics committee (CEIC); Recruiting sites: Administration Board and Local Ethical Committee
