In this page you will find regulations being published by local authorities at the Western Hemisphere, currently open to public consultation.
|Country / Institution||Name/Number of the Document||Comment Deadline||Link|
|BRAZIL||CP nº 1039/2021|
Proposal for a Collegiate Board of Directors Resolution about the general criteria for the use of analysis performed by Equivalent Foreign Regulatory Authority for the regularization of products subject to sanitary surveillance at Anvisa, through an optimized analysis procedure.
|BRAZIL||CP nº 1041/2021|
Proposal of Resolution of the Collegiate Board of Directors - RDC that disposes about the criteria for the concession or renovation of the Good Manufacturing Practices Certification for manufacturing establishments of Medical Devices.
|BRAZIL||CP nº 1042/2021|
Proposal of Resolution of the Collegiate Directorship -RDC that disposes about the requirements for the grouping of implantable materials in orthopedics for registration purposes
|BRAZIL||CP nº 1043/2021|
Proposed regulation for Importation, commercialization and donation of used and reconditioned Medical Devices.
|BRAZIL||CP nº 1035/2021|
Proposal for regularizing software as a medical device and makes other provisions.