INMETRO Changes Lower the Cost and Barrier to Market in Brazil

Foreign manufacturers to Brazil will no longer be allowed to obtain INMETRO certification directly in their own names under the new Portaria 350/2010 regulation. INMETRO Safety certification for medical devices with electrical and other components has changed in Brazil.

brazilUnder the revised Portaria 350/2010 regulation, the manufacturer’s Brazil Registration Holder will hold INMETRO certifications on their behalf, and current certifications will need to be revised to reflect the Brazil Registration Holder’s name.

Manufacturers should be aware of the new requirements, and assure that their potential Brazil Registration Holders can properly obtain INMETRO certification and manage ANVISA registration as part of their supplier qualification criteria.

The good news and some cost savings for manufacturers, though is Brazil’s National Health Surveillance Agency (ANVISA) recently enacted new regulations, making many medical devices with electrical components that require INMETRO certification exempt from 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, including:

  • 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 are no longer required to attain BGMP certification or pay the biennial fee, although INMETRO certification may still be required.

About Christopher Ford

Christopher Ford is an expert in global medical device manufacturing compliance with over 20 years of experience, specializing in Class II and Class III medical devices and combination products. He is a certified ISO 13485 Lead Auditor, with over 600 audits under his belt, and he works with organizations of all sizes. His approach to compliance requirements balances customer needs with business objectives, while assuring that all regulatory requirements are met.