Law 6360/1976: Regulation of Medical Devices and Correlative Products

Medical Devices and Related Products

• In Law 6360/1976, medical devices were considered part of a broader category of products, including food, cosmetics, and sanitary products, regulated due to sanitary protection reasons.

Definition of Medical Devices

• The current definition of medical devices is found in RDC 285/2001 and IVD in RDC 206/2006.
• A medical device is a health product that does not use pharmacological, immunological, or metabolic means to perform its main function in humans, but may be assisted by such means.

Definition of In Vitro Diagnostic (IVD) Products

• IVD products are reagents, standards, calibrators, controls, materials, articles, and instruments used to determine a sample originating from the human body, without performing any anatomical, physical, or therapeutic function.

ANVISA Regulation

• ANVISA regulations must comply with Federal Laws and Decrees.
• The General Office for Medical Product Technologies (GGTPS) is divided into three management departments: GQUIP, GEMAT, and GEVIT.
• GQUIP and GEMAT primarily perform premarket regulatory acts for products under RDC 185/2001, while GEVIT does the same for products under RDC 206/2006.

ANVISA Structure and Scope

• ANVISA interacts with various categories of products, including regulated food, cosmetics, sanitizing products, tobacco, drugs, medical devices, blood products, and more.
• ANVISA also interacts with areas such as post-market surveillance, advertisement, borders, health surveillance, health labs, healthcare facility service, toxicology, international relations, and the national health surveillance system.

ANVISA Resolutions and Instructions

• RDC 27/2008 establishes general rules for medical products made in Brazil for exportation only.
• RDC 34/2012 allows the use of electronic information for IVD products.
• RDC 185/2006 determines the guideline for economic data reporting to NUREM (ANVISA's Core Advisory in Economic Regulation).
• RE 3385/2006 lists products that require an Economic Information Report according to RDC 185/2006.
• Normative Instruction 03/2010 establishes definitions adopted by RDC 185/2006.