Anvisa (Brazilian Health Surveillance Agency) is adopting actions in
order to improve the import processes of healthcare products. RDC 15/2014
introduces significant changes to the Certificate of Good Manufacturing
Practices and aims to help the new technologies’ registration in Brazil.
First significant change is to validate auditing reports made by third parties (other
regulatory agencies). Also, Anvisa will no longer emit certificates for lower
risk products, as gloves, syringes and some surgical devices. Although this
measure removes the need for inspection, it does not change the criteria
of effectiveness and security required. Finally, Brazilian Health Surveillance
Agency will allow that the protocol of the certificate request is accepted to
submit registration applications, maintenance and amendments of highest risk
products. This means that a manufacturer will no longer need to wait for
grant of certificate to have an analysis of his products started. With
the two processes happening concurrently, the time of arrival of new equipment in
the market should be reduced.
No comments:
Post a Comment