2019/11/13

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, […]
2019/11/13

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 […]
2019/11/13

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 […]
2019/11/13

Good Practice Certification for Medical Product Storage and Distribution

Certification in Good Storage and Distribution Practices is applicable to importers and / or distributors who seek to demonstrate, with ANVISA, their excellence in importing, receiving, storing and distributing medical products – whether due to commercial differential or bidding demands. ANVISA Normative Instruction IN 08: 2013 determines the requirements of Good Practices related to Medical Products […]
2019/11/13

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