16 April 2019
Brazil’s Health Agency Implements New Regulatory Model
The Brazilian Health Agency (ANVISA) has implemented a new regulatory model aimed at improving domestic sanitary regulations. The agency indicates that the new model encourages social participation mechanisms so that there is greater interaction between technical areas, regulated sectors, the government, society at-large, and educational and consumer protection institutions. In addition to the customary channels of communication, such as targeted or public consultations, hearings and sectoral dialogues, parties will be able to use a new social participation tool (known as the Public Allowance Survey, or TPS) that provides for the discussion of technical documents describing matters under evaluation as well as potential regulatory options.
Under the new regulatory model, public consultations will last a minimum of 45 days (in lieu of 30 days) while public consultations involving matters with an international impact will last 60 days. These deadlines may be modified in exceptional circumstances. Moreover, ANVISA will publish on its website a greater number of documents and technical materials used to support its proposals, except for confidential information, in an effort to increase overall transparency.
Meanwhile, ANVISA implemented in late February a new electronic system for documents submitted to the agency’s General Management of Health Products Technology (GGTPS). The new system does not require the submission of physical copies, which is expected to result in significantly lower administrative and logistical costs for both participating companies and ANVISA.
In other news of potential interest, effective 2 May ANVISA will migrate its current registration system to a notification system for medical devices labelled as Risk I, which are those that pose a low safety risk. The agency defines medical devices as medical products and in-vitro devices (IVDs), as provided in ANVISA Resolution RDC No. 185/2001 and ANVISA Resolution RDC No. 36/2015. Product notification is carried out through a petition submitted to ANVISA, which generates a surveillance fee (TFVS). The notification number is published on the ANVISA website within 30 days after payment of the fee. Once that occurs, the product may be industrialised, offered for sale or delivered to the consumer.