Starting this year, two reports prepared by ABIMED to communicate to its members and other stakeholders regulatory, institutional, and legal subjects will be integrated into a single publication. Distributed monthly to the CEOs of the associated companies, in a bilingual version (Portuguese/English), this new publication will include the following content.

In the Regulatory Affairs chapter, among the topics that will be addressed is Public Inquiry (CP) 1123/22, which is being handled by our Regulatory Intelligence Committee, with the follow-up of the post-consolidation and rule publication; the RDC 548/21 review, which provides about clinical trials with medical devices in Brazil; the public inquiry shared with associates via circular; the contributions submitted; the negative impacts reported in the CP, referring to studies reporting to the sponsor.

Also will be addressed DRC 751/2022 – Registration and Notice, which was published in September 202 and goes into effect on March 1st of this year. The Regulatory Intelligence Committee raised questions about the implementation and new dossier, forwarded to ANVISA. The rule “Q&A” was also launched on January 29th. ANVISA held a webinar for all of Brazil on February 16th. The virtual seminar aimed to present the main topics of the College of Directors Resolution (RDC) 751/2022. The rule provides about risk classification, notice and registration regimes, labeling requirements, and use instructions for medical devices. In addition, ABIMED will promote a new edition of Saber ABIMED with ANVISA in March, addressing the entry into force without the Agency having made available new forms and explanations and/or summary denials.

In the chapter on Institutional and Governmental Relations (RIG), we will bring you the Industry 2023 Legislative Agenda from the Brazilian Board of Manufacturers (CNI). The goal is to contribute and act so that legislative proposals (bills, constitutional amendments proposals) of interest to the medical equipment and devices segment are contemplated in the agenda. We will also deal with the elaboration of positions and arguments for the inclusion of legislative proposals of interest to the medical equipment and devices segment, so that they are contemplated in the agenda and the active participation in the RedIndustria Seminar, where the Industry Legislative Agenda 2023 was built.

Another topic is the SINIEF adjustment 11/14, which “provides for the concession of a special regime in the internal and interstate shipment of medical-hospital implants and prostheses to hospitals or clinics”. The proposal is to improve the SINIEF Adjustment 11/14 according to the current scenario and dynamics of the medical equipment and devices market and in light of the technological advances experienced in recent years by federal and state tax administration agencies. The adjustments to ABIMED’s lawsuit are made according to the request made by GT 06-COTEPE/ICMS/CONFAZ. We also dealt with the alignment with other players that forwarded similar lawsuits to those of ABIMED, for the presentation of a unified lawsuit. And, also, the formulation of a unified lawsuit and formal presentation to CONFAZ for consideration at the 1st meeting of 2023 of Working Group 06.