Three primary-source actions this week shift the calendar for MedTech market access in Latin America. Brazil's CONITEC has activated a public consultation on a middle-ear auditory implant system, Peru's DIGEMID is operationalizing classification rules under Decree 010-2025, and Chile's ISP/ANDIM has formally launched Code 9200013 -- the country's first national manufacturer-certification pathway aligned to ISO 13485:2017.
Brazil · Peru · Chile · Colombia
Three primary-source actions this week shift the calendar for MedTech market access in Latin America. Brazil's CONITEC has activated a public consultation on a hearing-implant system that signals how the agency is treating implantable device incorporation. Peru's DIGEMID is operationalizing new classification rules, essential safety and performance principles, and technical-report requirements for medical devices. And Chile's ISP, through its Agencia Nacional de Dispositivos Medicos (ANDIM), has formally opened a manufacturer-certification service aligned to ISO 13485:2017 — the country's first regulatory pathway specifically built around early-stage Chilean MedTech.
Brazil's National Commission for the Incorporation of Technologies (CONITEC) has an active public consultation on a middle-ear auditory implant system for patients with mild-to-severe sensorineural hearing loss who cannot use conventional hearing aids for medical reasons. The consultation was published February 3, 2026 and was updated on May 7, 2026, placing it firmly inside the active comment window. The proposal is significant because it would extend SUS incorporation beyond cochlear implants into a distinct implantable-device class for a clinically narrower patient population.
Source: https://www.gov.br/conitec/pt-br/midias/consultas/contribuicoes/2026
Business implication: Implantable-hearing device manufacturers should treat the consultation as an opportunity to submit clinical evidence and budget-impact modeling. The decision pattern in 2026 — the artificial urinary sphincter (Portaria SCTIE/MS No 9, January 8) and the PreemieTest neonatal optical reader (148th Reuniao Ordinaria, February 6) — shows CONITEC is willing to incorporate single-purpose implantable and diagnostic devices when the unmet-need case is built around a defined population.
Peru's DIGEMID released Comunicado No 005-2026 on April 21, 2026, formally addressing technical directors of medical-device laboratories and droguerias. The communique rescheduled the technical session on three core subjects: classification rules for medical devices, essential safety and performance principles, and technical-report requirements. The session was held April 27, 2026. The technical content represents the operational implementation of Decree 010-2025 and aligns Peru with IMDRF classification logic.
Source: https://www.digemid.minsa.gob.pe/webDigemid/comunicados/2026/comunicado-n-005-2026/
Business implication: Foreign manufacturers selling devices in Peru should expect dossier requirements to shift toward IMDRF-aligned classification justifications, essential-principles checklists, and standardized technical reports. The training cadence (DIGEMID held the 004-2026 session April 14 on the same topics) suggests this is a near-term enforcement priority. Companies in dossier preparation for 2026 should validate their classification rationale against the new framework rather than legacy MERCOSUR criteria.
Chile's ISP / ANDIM has formally launched the new prestacion Certificacion de nivel de cumplimiento de fabricantes e innovadores under code 9200013. The service is structured as a phased path to NCh ISO 13485:2017 compliance and was developed under the CORFO-funded project Fortalecimiento del Instituto de Salud Publica de Chile para la Regulacion de Dispositivos Medicos. The ISP can now accompany Chilean manufacturers and innovators from design and development stages, a first for the country's regulatory infrastructure.
Business implication: For domestic Chilean MedTech companies and any international company partnering with a Chilean manufacturer, ISP/ANDIM certification under code 9200013 becomes the structured route to demonstrating regulatory readiness against international standards. The phased model reduces capital and compliance risk for early-stage device companies. International manufacturers seeking Chilean co-development partners should now evaluate partners against ISP/ANDIM certification status as a due-diligence input.
INVIMA's Direccion de Dispositivos Medicos y Otras Tecnologias issued multiple device safety alerts dated May 4, 2026, including Alerta No. 118-2026 on the Medtronic SynchroMed infusion pump clinician programmer software, Alerta No. 122-2026 on hemodialysis catheters with separable sheath introducers, and Informe de Seguridad No. 63-2026 on Beckman Coulter and Dako automated coloreador devices. All alerts trigger requirements for importers and distributors to coordinate corrective action and for healthcare institutions to report adverse events to the Programa Nacional de Tecnovigilancia.
Business implication: Colombia's post-market surveillance regime is now operational and proactive. Device titulares de registro should treat tecnovigilancia event reporting as both a compliance obligation and an early-warning system for product-quality issues. The cadence (multiple alerts in a single week) shows INVIMA has institutionalized the field-safety-notice process.
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