Gaslive Company Overview
A LOT OF STEPS
HOMOLOGATION
PROCESS
CONVENTIONAL HOMOLOGATION
THE HOMOLOGATION IN BRAZIL HAS TWO STEPS
1st step - InMetro Homologation
For InMetro we will need your ISO13485, Risk Management Report, Usability Report,
IEC test report with the date of emission less than 2 years, User Manual, Picture of the Packa
ge, Plug Certificate.
With all this documents in our hands, we hire a 3rd party company to analise and approve the
documents in InMetro, If all the documents are ok, then will be a factory inpsection in Ventec
and Gaslive. If the documents are not ok, then we need to send more evidences to then as
they request, until they approve it.
2nd step - Anvisa Homologation
For Anvisa we will need the following document
Distribution Letter (Consularized and Notarized).
With the Dsitribution letter, User Manual nad the InMetro Homologation, we can
apply for the Anvisa Homologation. Here our Departament of Homologation fill all
the necessary forms and send to Anvisa.
Deadline:
It will depend if you have all the necessary documents. If not we will need to hire a laboratory
here to perform some tests, then the deadline could be about 5 months.
Homologation Maintenance
Every year In Metro demands a Factory Audit performed by the 3rd party Brazilian
Company.View entire presentation