ANVISA Product Registration

When we talk about ANVISA ‘Registration’, we are talking about regularization for Hazard Class III and IV Medical Products. Other classifications have other names: ‘Notification’ for Risk Class I products and; ‘Register’ for products classified as Risk Class II.

ANVISA Resolution RDC 185: 2001 is the technical regulation that establishes the documents and information for registration, post-registration changes and revalidation of a health product with ANVISA. For certain products, in addition to meeting the requirements listed in ANVISA Resolution RDC 185: 2001, certification prior to regularization with ANVISA is required – from INMETRO and / or ANATEL, for example.

Also, to submit a product regularization petition, it is necessary that your manufacturing plant is certified in ANVISA Good Manufacturing Practices – regulated by ANVISA Resolution RDC 16: 2013. All submissions are made electronically by ANVISA’s system (see details in ANVISA’s online process submissions).

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Regulatory Framework