ANVISA PUBLISHES RDC 232, FOR MEDICAL DEVICES - Optel Group

On June 20, 2018, ANVISA published Resolution RDC232, which states that all labels for coronary artery stents, pharmacological stents for coronary arteries, and implants for knee or hip arthroplasty must now include traceability barcodes.

This process must follow recognized industry standards, namely GS1 or Health Industry Business Communications (HIBCC). All barcodes must contain the following data:

A minimum of three (3) copies of the tracking label must be produced for medical device packaging and these labels must then be applied to: 1- the medical file, 2-the document provided to the patient, and 3- the legal/financial documentation related to billing or fee coverage. No barcode other than the one specified above can appear on the tracking label.

This Resolution comes into effect two (2) years after publication.

For more information regarding available solutions to help comply with this regulation, please contact us. With nearly 30 years of industry experience, OPTEL is the leading provider of traceability systems.