ANVISA expands list of items not considered “health products”

By Stewart Eisenhart, Emergo Group

Brazilian medical device regulator ANVISA has added several products used in laboratory settings to its list of items not deemed “health products” and therefore not regulated as medical devices or in vitro diagnostic (IVD) devices in the country.

Under the new “Category 10” on the list, ANVISA includes the following types of products:

• Laboratory glassware and instruments for general use (pipettes, graduated cylinders, petri dishes)
• Isolated chemical reagents not specifically purposed for IVD reagents or kits
• Culture media such as powders or supplements used to enrich other unfinished products
• Biological indicators
• Reagents and reference materials meant for quality assessments in laboratory settings
• Reagents assembled in clinical analysis laboratories and intended for use in those same institutions in a non-commercial manner
• Laboratory reagents not meant for diagnosing human samples
• Products used for sports doping control tests
• Products intended only for research and labeled accordingly (“Research Use Only,” or RUO)
• Gas generators and anaerobic indicators
• Reagents sold as supplies for manufacturing IVDs in the intermediate production stage
• Products used for legal medicine (police investigations and reports)
• Products used exclusively for cleaning and maintenance of IVD instruments not available on the Brazilian market (calibration instruments, cleaning solutions)

Additional information on medical device classification and approval in Brazil can be found in our video overview and regulatory process chart.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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