TESTS AND ANALYSES - THEMES

How can CENIC Lab help?

CENIC Laboratory assists its clients in the phase of proving product effectiveness and safety, offering the following services:

Critical analysis / ATRIO consulting;;
Test routes;
• Performance of standardized tests accredited by INMETRO’s CGCRE and approved by REBLAS/ANVISA.

 

ANVISA – Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency) is the body which regulates manufacture, importation and commercialization of healthcare products in Brazil.

Orthopaedic, dental and breast implants figure among the healthcare products which in order to be manufactured, imported and/or commercialized require registry with ANVISA.

 
ANVISA publishes laws and regulations (RDC) that establish the various steps for registry of a determined product, from product risk, family classification and manufacturer audits through to proof of product’s effectiveness and safety. Effectiveness and safety must be demonstrated by the applicant by means of the document called “technical report “.

In accordance with RDC Nº 185 of 2001 “the technical report must contain description of effectiveness and safety of the medical product, in conformity with ANVISA regulation which addresses Essential Effectiveness and Safety Requisites of Medical Products.” RDC Nº 56/2001 establishes the mentioned requisites.