In 2026, Brazil’s ANVISA is undergoing regulatory upgrades at a remarkable pace. This article provides a complete breakdown of key changes within Brazil’s medical device regulatory framework for 2026‑2027, helping stakeholders identify trends, calculate compliance costs and make adequate preparations.
https://saude.es.gov.br/Media/sesa/Legisla%C3%A7%C3%A3o/Outros/Instru%C3%A7%C3%A3o%20Normativa%20-%20IN%20n%C2%BA%20283,%20de%2007_03_2024.pdf
Thirty‑one medical device categories in total will be subject to mandatory requirements, covering dialysis equipment, neonatal care devices, patient monitors, dental equipment, respiratory support devices, wheelchairs and hygiene aids.
Important Risk Reminder: Even for products holding existing ANVISA registration certificates, valid INMETRO certificates must still be presented for import clearance after 31 December 2026. If an INMETRO certificate expires, the corresponding ANVISA registration shall become invalid concurrently.
Timelines for enterprises are tight. Certification includes laboratory testing and factory audits. Enterprises are advised to launch assessments immediately to avoid end‑of‑year application backlogs that may block product shipments.
Under ANVISA’s 2026‑2027 Regulatory Agenda (Ordinance No. 1.484/2025, effective 1 January 2026), amendments will be made to RDC No. 687/2022. The plan is to make MDSAP audits compulsory for overseas medical‑device manufacturers as the primary or even sole pathway for GMP certification.
MDSAP remains voluntary in Brazil at present, yet it has already achieved de‑facto semi‑mandatory status. Since 2024, more than half of Brazil’s GMP certificates have been issued via the MDSAP route, making MDSAP the mainstream market‑access pathway.
On 18 February 2026, ANVISA issued Normative Instruction No. 426/2026, setting operational rules for SIUD (Sistema de Informação de Identificação Única de Dispositivos Médicos), Brazil’s national UDI database. This normative instruction entered into force on 1 March 2026.
SIUD serves as Brazil’s domestic UDI digital platform, comparable with FDA’s GUDID and the EU’s EUDAMED. It constitutes the core operational implementation vehicle for UDI regulation RDC No. 591/2021.
UDI data must be submitted to SIUD before products are placed on the Brazilian market. The Brazilian Registration Holder (BRH) or domestic Brazilian manufacturer may authorise third‑party agents for submission; however, legal liability remains with the BRH.
On 1 July 2026, WHO released the first batch of the Transitional List of WHO‑Recognised Authorities for Medical Devices (tWLAs‑MD), which includes Brazil’s ANVISA.
Practical implications for enterprises: tWLAs‑MD delivers a WHO‑endorsed regulatory‑reliance signal. Assessment conclusions issued by listed authorities may be referenced by other jurisdictions to streamline review procedures. This framework does not constitute automatic mutual recognition. Each state retains full sovereignty over product approvals, yet formal foundations for global regulatory coordination are established.
Deepened International Cooperation：Sign bilateral cooperation agreements with China NMPA, South Korea MFDS and other authorities; participate intensively in global regulatory harmonisation.
