The Brazilian Health Regulatory Agency (ANVISA) launched four public consultations concerning a new regulation on medical software, a normative instruction on hygiene products and two amending proposals on health services. They aim at improving regulatory quality and legal security.
The Brazilian Health Regulatory Agency (ANVISA) submitted four different regulatory proposals to public consultation, aiming at improving regulatory quality and legal security:
(1) Public Consultation n. 3/2020 seeks to establish a new regulation on software applied to medical devices or with medical use, according to ANVISA’s perception that medical software requires a specific regulation that differs from that applied to medical equipment.
ANVISA presented a preliminary Regulatory Impact Analysis (RIA/AIR) that will conduct the regulatory process on the subject, which is a part of its regulatory agenda for the period 2017-2020. The contribution form is composed of 13 questions that explore four themes, related to the regulatory problem, the identification and comparison of options and the implementation process.
(2) Public Consultation n. 909/2020 presents a normative instruction proposal related to industrial facilities that share the production of cosmetics destined for human use and veterinary hygiene products. The goal of the proposal is to clarify that cosmetic ingredients can only be used in both production processes if interchangeable, i.e. if they could be approved and regulated for both uses. Since it is a proposal that does not alter any product or company authorizations, an AIR was exempted.
(3) Public Consultation n. 911/2020 presents an altering proposal to RDC n. 44/2009, related to Good Pharmaceutical Practices for the sanitary control of pharmaceutical services (operation, dispensation and commercialization). The main goal is to update and uniform regulatory provisions, covering topics such as terminology, notification systems and removal of method restrictions. The public consultation also presents an AIR.
(4) Public Consultation n. 912/2020 aims at expending the role of RDC n. 302/2005, which regulates clinical laboratories, in order to incorporate technical requirements on activities related to Clinical Analysis Tests (TAC, in the Portuguese acronym) and Diagnostic and Therapeutic Support Services (SADT, in the Portuguese acronym). The amending proposal provides the inclusion of activities and updates on quality control requirements. An AIR is also presented.
The four public consultations launched by ANVISA are summarized as follows:
- Public Consultation n. 3/2020 on medical software. A preliminary AIR, a regulatory plan under ANVISA’s regulatory agenda 2017-2020 and more information can be found here (in Portuguese). Contributions can be submitted until October 14 through this digital form (in Portuguese);
- Public Consultation n. 909/2020 on hygiene products. More information can be found here. Contributions can be submitted until October 16 through this digital form (in Portuguese);
- Public Consultation n. 911/2020 on pharmaceutical services. An amending proposal to RDC n. 44/2009, an AIR and more information can be found here (in Portuguese). Contributions can be submitted until October 23 through this digital form (in Portuguese);
- Public Consultation n. 912/2020 on clinical laboratory activities. An amending proposal to RDC n. 302/2005, an AIR and more information are available here (in Portuguese). Contributions can be submitted until October 23 through this digital form (in Portuguese).
