3 Feb 2012
Brazil Issues Conformity Certification Requirements for Syringes/Needles, Technical Requirements for Microwave Ovens
Brazil’s National Institute of Technology, Normalisation and Industrial Quality (INMETRO) issued on 30 December 2011 two directives (INMETRO Directives 501/2011 and 503/2011) that establish new certification standards for single-use sterile hypothermic syringes, single-use sterile hypothermic needles, and single-use sterile gingival needles. The directives require suppliers of covered syringes and needles to certify their products using certification systems 5 or 7 to ensure compliance with applicable safety requirements. “System 5” is based on an evaluation of the manufacturer’s quality management system and the testing of samples taken from the production line while System 7 requires every imported lot to be tested to ensure regulatory compliance.
The syringes and needles will have to carry an INMETRO seal in order to be commercialised in Brazil. That seal will normally have to be printed on the primary packaging of the product, that is, the packaging that comes into direct contact with the product. In the case of packages of insulin syringes that contain multiple syringes, the seal will have to be printed on that package. In the case of needles and syringes commercialised together with medical devices intended for a single procedure, the seal must be printed on the primary packaging of the set.
Syringes and needles will have to comply with these requirements by 2 February, which is the date of entry into force of the applicable minimum identity and quality requirements for these products that were approved in February 2011 (ANVISA Resolution 3/2011 for syringes and ANVISA Resolution 5/2011 for needles).
INMETRO also recently issued a resolution (INMETRO Resolution 503/2011) establishing new technical requirements for microwave ovens. The regulation sets forth the performance, energy efficiency, marking/instructions and safety requirements that microwave ovens will have to comply with when applying for conformity certification as laid out in INMETRO Resolution 497/2011.