New regulations were recently enacted by Brazil's National Health Surveillance Agency (ANVISA). Under the new regulations, manufacturers of Class I or II medical devices with electrical components that require INMETRO certification will now no longer require obligatory compliance with Brazilian Good Manufacturing Practices (BGMP) inspections.
ANVISA's Normative Instruction (IN) 2/2011, which replaces IN 7/2010, provides a specific list of Class I and II electronic devices requiring BGMP certification. Many Class I and II electronic medical devices are not included in this list and now require only INMETRO certification as part of their ANVISA registration in Brazil. Please note, all Class III and IV medical devices, whether they contain electrical components subject to INMETRO or not, still require BGMP certification.
The new list of Class I and II electronic medical devices requiring BGMP certification includes:
- Equipment used to disinfect and sterilize medical equipment
- Equipment for processing blood components used in infusion procedures
- Medical software not embedded in equipment used for medical imaging, diagnostic or surgical purposes
- In vitro diagnostic devices such as biochemical analyzers, immunoassay analyzers or glucose meters used to test samples derived from a human body
- Dialyzer reprocessing equipment
- Medical image processing equipment
- Resonance imaging devices
- Devices that produce in-vivo images of radiopharmaceutical distributions
- Ultrasound imaging equipment
- Endoscopy systems with surgical applications
Unlike under IN 7/2010, where all Class I and II devices subject to INMETRO certification were automatically required to also comply with BGMP, manufacturers of Class I and II electrical medical devices not on the list above no longer have to obtain BGMP certification, nor pay the biennial fee or go through re-certification every two years in order to register their devices in Brazil, although INMETRO certification may still be required. As such, manufacturers whose Class I and II medical devices do not appear in the IN 2/2011 list now have the benefit of lower costs to sell in Brazil.