ANVISA Clarifies Registration Requirements for Accessory Devices

Medical device market regulators in Brazil have issued a new technical note (link in Portuguese) explaining that medical devices packaged as accessory or secondary products with other devices or drugs are exempt from registration requirements.

ANVISA exempts accessory medical devices from registration but not BGMPExamples of such devices include needles, droppers, syringe cups and other products typically used to dose or administer medications.

However, ANVISA still requires manufacturers of these devices to maintain appropriate quality control and comply with Brazilian Good Manufacturing Practices (BGMP). All manufacturers and importers of medical devices to Brazil must maintain BGMP compliance regardless of whether such compliance is verified by ANVISA audits.

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