Good Clinical Practice in Brazil in 2026: What ANVISA's New Reports Reveal About the Future of Medical Devices

Executive summary

• ANVISA has published its 2nd Annual Report on GCP Inspection Metrics (2024-2025 data) and its 9th Annual Report on Clinical Research Activities, the first to reflect fully the new framework of Law 14.874/2024, RDC 945/2024 and IN 338/2024.
• Although focused on medicines, these reports indicate the level of scrutiny that will be applied to the medical device clinical investigation framework (RDC 837/2023, RDC 751/2022 and RDC 848/2024).
• For Brazilian and international manufacturers, the competitive window is open: those who align their QMS (RDC 665/2022 + ISO 13485), clinical evidence (ISO 14155, ISO 14971) and remote inspection capability ahead of the curve gain predictability, speed and credibility with ANVISA.
• HSC Global Group works at precisely this point: structuring medical device manufacturers' regulatory and quality operations so that they enter Brazil and Latin America with controlled risk.

1. Why these two ANVISA reports change the game

In May 2026, during preparations for Hospitalar, Latin America's largest healthcare trade fair, ANVISA published two pieces of regulatory intelligence that deserve the attention of the entire medical device supply chain: the 2nd Annual Report on Good Clinical Practice Inspection Metrics and the 9th Annual Report on Clinical Research Activities.

The first consolidates findings from inspections conducted in 2024 and 2025. The second, broader report shows how Brazil's clinical research sector has adapted to the new regulatory framework in force since 2 January 2025, comprising Law 14.874/2024 (Brazil's new legal framework for clinical research), RDC 945/2024 and Normative Instruction 338/2024.

Technically, both documents address medicines and biological products. Strategically, however, the message is broader. ANVISA is consolidating a culture of inspection, transparency and regulatory reliance that, through natural convergence, also redefines the level of scrutiny for medical devices. For regulatory affairs and quality professionals in the device sector, these reports provide an early map of what lies ahead.

Brazil has moved beyond being a regulatory destination where each application is assessed in isolation. It is positioning itself as a mature regulator, with public criteria, auditable metrics and active reliance mechanisms. This fundamentally changes how manufacturers should plan market entry.

2. Good Clinical Practice in Brazil: what is established

Before discussing convergence, the foundations need to be clear. Good Clinical Practice (GCP) is the set of international standards for designing, conducting, recording and reporting clinical research involving human participants. In Brazil, ANVISA's operational reference is ICH E6(R2), with progressive convergence towards ICH E6(R3), finalised internationally in 2025.

For medicines and biological products, the framework reached a new level through three regulatory instruments published in succession:

• Law 14.874/2024, Brazil's first specific legal framework for clinical research. In force since 29 August 2024, it provides legal certainty for sponsors and investigators and aligns Brazil with international standards.
• RDC 945/2024, which repealed RDC 9/2015 and governs clinical trials involving medicines, with defined assessment deadlines and formal provision for remote and hybrid inspections.
• IN 338/2024, which implements RDC 945, including the optimised assessment procedure through regulatory reliance on Equivalent Foreign Regulatory Authorities (AREE).

This package brought Brazil closer to the clinical research regulatory standards adopted by jurisdictions such as the FDA, EMA and Health Canada. ANVISA is consolidating an international culture of clinical quality with Brazilian characteristics, rather than simply copying it.

2.1. What the newly published reports say

The 2nd Report on GCP Inspection Metrics provides an overview of inspections at research sites, sponsors and clinical research organisations (ORPC) during 2024 and 2025. Three observations stand out:

• A mature inspection programme. Inspections, suspended during the pandemic and resumed in 2023, now follow regular cycles, with criteria aligned with ICH E6(R2) and predictable processes.
• Public transparency. ANVISA maintains a consolidated inspection dashboard dating back to 2009. The performance of sites and sponsors has moved from confidential information to market intelligence.
• Increasing adherence to GCP. Brazilian sites and sponsors demonstrate consistent compliance, strengthening international confidence in clinical data generated in Brazil.

3. What about medical devices? The parallel framework and where it meets GCP

Unlike the medicines framework, clinical research involving medical devices in Brazil has its own regulations. Its main pillars today are:

• RDC 751/2022, which classifies medical devices by risk (I, II, III, IV) and establishes requirements for regulatory approval.
• RDC 837/2023, which updates the rules on medical device clinical investigations. In force since 4 January 2024, it aligns Brazil with international practice and simplifies the process: all documentation is now submitted through a single Medical Device Clinical Investigation Dossier (DICD) procedure.
• RDC 848/2024, which addresses device safety and performance, including mandatory submission of specific clinical investigation reports for innovative devices and Classes III and IV.
• RDC 665/2022, Good Manufacturing Practice (GMP) for medical devices, aligned with ISO 13485.

RDC 837/2023 establishes a point that is frequently underestimated: clinical investigations involving Class I and II medical devices must follow GCP even when exempt from prior submission to ANVISA. GCP is the standard of clinical conduct ANVISA expects for every medical device tested in human participants in Brazil, extending beyond medicines alone.

3.1. When a DICD is mandatory

DICD submission to ANVISA is required for:

• Clinical investigations involving Class III or IV medical devices not yet registered in Brazil.
• Registered devices with an indication for use different from the approved indication.
• Investigations whose results will demonstrate safety and effectiveness in a future registration.

The following do not require submission to ANVISA (but must follow GCP):

• Investigations involving Class I and II devices.
• Post-market research involving registered devices within their approved indications.

3.2. The quiet convergence between the two frameworks

This is where the picture becomes interesting. Although medical devices follow their own regulations, three ANVISA developments are rapidly bringing the two frameworks closer:

ICH E6 as a common language

ANVISA's GCP inspection guides are based on ICH E6(R2). With ICH E6(R3), principles such as proportionate risk management, quality by design and oversight of electronic systems become references for any clinical research, including medical device investigations under RDC 837/2023.

Remote and hybrid inspections

RDC 945/2024 formalised for medicines what the device sector had already been experiencing: ANVISA may conduct fully remote or hybrid inspections. This substantially reduces logistical barriers to inspecting foreign manufacturers and imposes a new standard of documentary and technological readiness.

Reliance and regulatory trust

The reliance mechanism, central to the new clinical research regulation, follows the same logic that supports MDSAP in medical devices. Brazil, a participating MDSAP regulatory authority, is applying this philosophy of regulatory trust throughout its chain. For international manufacturers, this means faster routes to the Brazilian market and an expectation that quality processes will withstand scrutiny from multiple authorities simultaneously.

4. Regulatory convergence: medicines × medical devices in Brazil

The table shows what reading each regulation in isolation does not: structurally, the two frameworks are moving in the same direction. Inspections proportionate to risk, defined deadlines, international regulatory reliance and a quality-by-design culture are common trends. For medical device manufacturers, the standard required in medicines clinical research today is a useful proxy for the standard that will be required for devices tomorrow.

5. Practical implications for medical device manufacturers

What does this mean operationally? If your company manufactures medical devices and plans, conducts or sponsors clinical investigations in Brazil, for local registration or as part of a global study, five areas need to be mature:

5.1. A Quality Management System suited to current scrutiny

The QMS must be fully aligned with RDC 665/2022 and ISO 13485, with documentary traceability meeting the standard expected in a combined GMP and GCP inspection. This includes supplier control, change management, design control and structured, auditable CAPA.

5.2. A robust Clinical Evaluation Plan

Clinical evaluation, under ISO 14155 and the principles of RDC 848/2024, should follow a cumulative evidence approach: literature, post-market data, clinical equivalence and specific investigations where applicable. For innovative devices and Classes III and IV, device-specific clinical data are, in practice, mandatory.

5.3. Risk management integrated throughout the lifecycle

ISO 14971 is no longer an isolated document. In recent inspections, ANVISA has assessed whether risk management is actually integrated with design control, clinical evaluation, manufacturing and post-market surveillance. This is precisely the quality-by-design concept ICH E6(R3) brings to GCP and which ANVISA has adopted as an expectation.

5.4. Readiness for remote inspection

Remote inspections require digitised, indexed documentation, validated systems with genuine audit trails, controlled access to evidence in real time and teams comfortable conducting inspections by videoconference. This is more than "the same inspection over Zoom": it is a different type of inspection, and those treating it as the same event often fail.

5.5. Post-market surveillance and technovigilance

Brazil's technovigilance system (Notivisa) is the other end of the chain. Recent GCP inspections show that ANVISA cross-checks clinical adverse event data against post-market notifications to assess the consistency of a manufacturer's quality system. Inconsistencies between the two sources raise a red flag.

6. The international manufacturer's case: why Brazil should be on your map

For international manufacturers, particularly those from China, South Korea, Germany, the United States and Italy, Brazil offers an increasingly rare combination of scale, predictability and opportunity. Three factors deserve consideration together:

• A robust healthcare market. Brazil is the world's 9th-largest economy, with a universal public health system (SUS) and a vigorous private sector. Demand for imported medical devices is structural.
• A regulator participating in MDSAP. ANVISA accepts MDSAP audits for GMP certification, significantly shortening the regulatory pathway for manufacturers already operating in MDSAP jurisdictions.
• Growing regulatory maturity. The GCP reports and new clinical research framework indicate a predictable regulator with public deadlines and a willingness to engage in international regulatory reliance.

For international manufacturers, the equation is clear: Brazil demands rigour but offers predictability. Companies understanding this enter the market faster and with less rework than those treating ANVISA as "just another local agency".

7. How HSC Global Group structures this journey

HSC Global Group is a Brazilian consultancy specialising in regulatory affairs and quality management for medical devices. We support Brazilian manufacturers and international manufacturers seeking ANVISA approval as a gateway to Latin America.

Our work covers the full cycle:

7.1. ANVISA medical device registration

• Preliminary assessment of regulatory classification and risk class (RDC 751/2022).
• Structuring the Technical Dossier and Clinical Evaluation.
• Managing submissions, technical deficiency requests and follow-up through to publication in the Brazilian Official Gazette (DOU).

7.2. Quality Management System

• QMS implementation and remediation under RDC 665/2022 and ISO 13485.
• Internal and supplier audits.
• Preparation for certification and ANVISA inspections, including remote inspections.

7.3. MDSAP, EU MDR/IVDR, FDA QMSR

• MDSAP Lead Auditor Nicolas Crispim, HSC's CEO, and Exemplar Global RTP for MDSAP.
• Gap analysis and QMS implementation compatible with multiple jurisdictions.
• Comprehensive support for UDI and unique device identification.

7.4. Clinical, Biological and Preclinical Evaluation

• Clinical Evaluation Plan under ISO 14155 and RDC 848/2024.
• Biological evaluation under ISO 10993, in partnership with clinical specialists.
• Special process validation and qualification of critical suppliers.

7.5. HSC Academy: technical training for your team

Specialist courses in MDSAP Lead Auditor, ISO 13485 Internal/Lead Auditor, ANVISA registration, FDA QMSR, EU MDR/IVDR, ISO 10993, special process validation, UDI and more, developed to train regulatory and quality teams to international standards.

Next steps

If your company is developing a clinical or regulatory strategy for Brazil, or would like to assess QMS maturity against ANVISA's new inspection landscape, speak to HSC Global.

We work with manufacturers who understand regulation as the means by which innovation reaches patients safely. We are ready to support that journey, from the initial assessment to registration publication.

Contact: hscglobalgroup.com

HSC Global Group: regulatory excellence for those bringing innovation to patients.

Frequently asked questions

Does Good Clinical Practice apply to medical devices in Brazil?

Yes. Even Class I and II device clinical investigations exempt from prior ANVISA submission under RDC 837/2023 must follow GCP. DICD submission is mandatory for unregistered Class III and IV devices.

What is the difference between DDCM and DICD?

DDCM (Drug Clinical Development Dossier) is the document submitted to ANVISA for medicines clinical trials, governed by RDC 945/2024. DICD (Medical Device Clinical Investigation Dossier) is its medical device equivalent, governed by RDC 837/2023.

Does Brazil accept clinical investigation reports produced abroad?

Yes, subject to criteria. ANVISA assesses whether the investigation followed recognised international standards (GCP, ICH E6, ISO 14155) and whether the data apply to the Brazilian population. For innovative devices and Classes III/IV, RDC 848/2024 may require clinical data specific to the device being assessed.

Does an MDSAP audit replace ANVISA inspection?

For Good Manufacturing Practice certification, ANVISA accepts the MDSAP report, significantly reducing regulatory time and costs. However, ANVISA may conduct a direct inspection at any time, particularly in clinical investigation and technovigilance contexts.

How can a foreign manufacturer begin a regulatory strategy in Brazil?

Three initial steps: (1) assess the device's regulatory classification and risk class under RDC 751/2022; (2) ensure QMS compatibility with RDC 665/2022 and ISO 13485; (3) identify a Brazilian Registration Holder or structure the operation with support from a local regulatory consultancy. HSC Global supports every stage.

Sources consulted

• ANVISA, 2nd Annual Report on Good Clinical Practice Inspection Metrics (2024-2025).
• ANVISA, 9th Annual Report on Clinical Research Activities.
• Law 14.874, of 28 May 2024.
• RDC 945/2024 and Normative Instruction 338/2024.
• RDC 837/2023, Medical device clinical investigations.
• RDC 751/2022, Medical device classification.
• RDC 848/2024, Medical device safety and performance.
• RDC 665/2022, Good Manufacturing Practice for medical devices.
• ICH E6(R2) and ICH E6(R3), Good Clinical Practice.
• ISO 13485, ISO 14155, ISO 14971, ISO 10993.