Brazil IVD Requirements – Aligned with GHTF Principles

Brazil’s regulatory agency, Anvisa, has introduced reforms to simplify classification processes for IVD products.  From the 18^th of May 2012 IVD manufacturers will be subject to new regulations which are aligned with the Global Harmonisation Task Force (GHTF) principles and therefore similar to the world’s major IVD markets. The new system is characterised by 9 classification rules which are based on the following 5 criteria:

• The product’s indication, as specified by the manufacturer;
• The level of technical, scientific, or medical knowledge of the user;
• The importance of the information generated by the test result to establish the diagnosis;
• The importance and impact of the result for the individual patient and for public health; and
• The epidemiology implications.

The new regulations will replace the current classification system (adopted under Resolution RDC 206/2006) which does not establish the rules defining how product risk should be determined by the manufacturer. Anvisa recognise the current regime has resulted in confusion within the industry. It is consequently hoped the new regulation will bring clarity and assist manufacturers to develop the required registration documentation.

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