Brazil - Minimum Quality and Identity Requirements of Infusion Sets

The Anvisa Resolution RDC No. 4 of February 4, 2011, sets out the minimum identity and quality requirements for infusion sets. This resolution uses national and international technical standards as a reference. The technical standards of the International Organization for Standardization, ISO, were recently revised and the new versions are being internalized by the Brazilian Association of Technical Standards - ABNT, as it is a signatory to ISO.

The new versions brought changes in infusion sets testing requirements as well as changes in their connections. The changes also impact the compulsory certification of infusion sets, under the Brazilian Conformity Assessment System (SBAC), since for certification, the Product Certification Bodies, OCPs, use as reference the technical standards and requirements transcribed to ANVISA Resolutions and INMETRO Decrees.

Therefore, if the new versions of ISO are internalized by ABNT without revision of such programs, there will be a significant misalignment between ANVISA / INMETRO Regulations and technical standards, making certification maintenance impossible and, in the extreme of its consequences, leading to a health system shortage of such products.

Contributions are accepted by filling in the specific form in the Anvisa Public Consultation Contributions link between September 25 and November 8, 2019. 

Source Link: Anvisa Public Consultation No. 710