The new regulatory scheme for Software as a Medical Device approved by Anvisa

This Wednesday (23), the Brazilian Health Regulatory Agency (ANVISA) approved a Collegiate Board Resolution (RDC) which addresses the regularization of software as medical devices (the so called “SaMD”).

 The SaMDs, regulated by ANVISA as medical equipment, will continue to be regulated within the category of Medical Devices and through their general provisions, particularly the RDC n° 185/2001 and RDC n° 40/2015, reinforcing the supplementary character of this new regulation. 

 The new rule aims to solve some gaps, inadequacies and obsolete traits of the regulatory framework that has been applied to the SaMDs up to now, according to all references set forth by the Regulatory Impact Analysis regarding the specificities that guide the softwares, the exponential growth in the use of technology in the healthcare sector and also the exponential and constant advances on this front, as for example, (i) the lack of security and effectiveness in similar information systems, such as Medical Device Data (MDDS), Free Software, Software as a Service (Cloud, Web, etc.) and Software developed internally; (ii) inadequacy of the risk classification applied to SaMDs until then; (iii) misalignment with the position of international health authorities and with the International Medical Device Regulators Forum – IMDRF, which Brazil is a signatory of; (iv) insufficient hardware requirements regarding software security and effectiveness, among others.

 Bruna Rocha, CMA’s Life Sciences, Healthcare, Cannabis Partner mentions that “the critical issue that has driven Anvisa to this new rule was the lack of clarity on the obligations surrounding the SaMDs. Of course a manufacturer of a software as a medical device must ensure that the relevant regulatory requirements are met before placing the product onto the market, however these relevant regulatory requirements were not clear. Now they are. It is a good first step towards sustainability for this segment”.

 The rule comes into effect on July 1st this year, however its terms must be taken into consideration right away when it comes to the software development process as well as to the planning/scheduling of any measures required to comply with such new guidance, as established in the RDC under discussion – “all regularization processes granted prior to the effectiveness of this Resolution shall be amended or complemented in the context of its future amendments”.

 For further information on this, please do not hesitate to contact us. We also take the opportunity to invite you to get to know our practice in the Life Sciences, Healthcare and Cannabis industry sectors.

Main Contacts:

Bruna B. Rocha
Partner – Life Sciences, Healthcare, Cannabis

Juliana Marcondes de Souza
Associate – Life Sciences, Healthcare, Cannabis

Victoria Cristofaro Martins Leite
Associate – Life Sciences, Healthcare, Cannabis