(Published July 2011)
We write to inform you of new regulations recently enacted by Brazil's National Health Surveillance Agency (ANVISA). Under the new regulations, manufacturers of many medical devices with electrical components that require INMETRO certification will now be exempt from 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 electronic devices requiring BGMP certification. Many electronic medical devices are not included in this list and now require only INMETRO certification as part of their ANVISA registration in Brazil.
The new list of 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
Manufacturers of 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 medical devices do not appear in the IN 2/2011 list now have the benefit of lower costs to sell in Brazil.
Please do not hesitate to contact us with questions regarding how IN 2/2011 affects the ANVISA registration process for electronic medical devices, or to find out more in general about the medical device registration process in Brazil.
Best regards,
Ann Marie Boullie
Director of Business Development - Latin America
