Customized Solutions in Regulatory Affairs and Quality System


Petitions for product regularization


Training provided


Consulting projects




Years of experience

Blog articles


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 […]

Good Medical Manufacturing Practice Certification

ANVISA Resolution RDC 665 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 are […]

Registration and Notification of Products at ANVISA

Medical Product Registration is applicable to Risk Class II products and has its regulatory requirements determined by ANVISA Resolution RDC 40: 2015. The products with the lowest risk are classified in Risk Class I, and for this they require Notification with ANVISA, in accordance with the requirements of ANVISA Resolution RDC 270: 2019. The main difference […]

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, […]

Interested in our Services? Contact us!