RDC 16:2013


ANVISA Product Registration

When we talk about ANVISA ‘Registration’, we are talking about regularization for Risk 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, […]

Good Medical Manufacturing Practice Certification

ANVISA Resolution RDC 16: 2013 sets out the requirements for Good Medical Product Manufacturing Practice. The certification of compliance with the requirements of this regulation, by the company that manufactures medical products – regardless of the country in which it is located, is a demand for the subsequent registration of these products in ANVISA – which […]

Business Operation Authorization – AFE

For an organization to operate in the Health Products supply chain – in manufacturing, importing, storing, transporting and / or distributing activities, an organization must obtain a Business Operating Authorization (AFE) from ANVISA. To this end, it should initially require its sanitary regularization with the local – municipal or state Sanitary Surveillance, depending on the activity […]
Regulatory Framework