Product rejected by ANVISA: what now?
A rejection is not the end of your product in Brazil. See the two paths, the 30-day appeal deadline and what to do before…
The Sobel blog
Technical analysis of ANVISA, EU MDR and IVDR, FDA, MHRA and Health Canada, and what each change means for your timeline, costs and market strategy.
Curated byMaik EndlerFounder & CEO, Sobel
A rejection is not the end of your product in Brazil. See the two paths, the 30-day appeal deadline and what to do before…
A technical requirement is a chance to complete your application, not a refusal. The 120-day deadline, why answers fail and how to structure a…
Part of the wait is normal. How to tell queue from problem, why a missed technical requirement is the biggest risk and what to…
Most stalled dossiers have formal or consistency gaps, not serious errors. The five families of errors and how to keep your dossier from coming…
ISO 10993-1:2025 is now ABNT NBR in Brazil. See what changes in biological evaluation for ANVISA registration.
Your devices have been on the EU market for years. They have valid certificates, a technical file and a vigilance process. But if they…
Generative AI medical devices are moving into a new regulatory phase. In its 2026 discussion paper, the FDA examines how risk, evidence, postmarket monitoring…
ANVISA has introduced a new petition structure for requests involving substances, functions, packaging and physical forms used in personal hygiene products, cosmetics and perfumes…
ANVISA has opened a new opportunity for manufacturers of innovative medical devices seeking a clearer regulatory path in Brazil. In August 2026, the Agency…
Understand how ANVISA’s RDC No. 1,030/2026 may impact cosmetic formulations, product portfolios, and regulatory compliance deadlines in Brazil.
Anvisa advances its Regulatory Sandbox initiative for personalized cosmetics while global regulators strengthen post-market surveillance.
Learn more about the FDA’s regulatory framework for AI-powered medical devices and other global recent updates.
In the development and approval process of medical devices, three types of evaluations frequently appear in regulatory requirements: biological evaluation, clinical evaluation, and toxicological…
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn more.
Alternatives for cosmetic animal testing advance with new FDA guidance and other global updates.
Learn how cosmetic registration works in the main global markets, including the U.S., EU, and Brazil, and plan a safe export strategy.
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
The UK regulatory authority opens a consultation on CE mark recognition and highlights other key global regulatory updates.
Learn how MDR CE Mark certification for medical devices works and prepare your product for successful entry into the European Union market.
Global updates on MDR and IVDR, the QMSR in the U.S., and new regulatory requirements for cosmetics in China and the U.S. market.
Understand the impacts of the EU MDR IVDR on the European market and the key global regulatory movements shaping the future.
While the FDA strengthens cosmetic recalls, the EU and China are making important regulatory updates.
Entering the U.S. medical device market can be a major opportunity for international companies. However, to operate legally and safely, companies must meet FDA…
The FDA has published a new guideline aligned with ICH Q3E to support the assessment of Extractables & Leachables (E&L), along with supporting documentation…
Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and TGA.
Learn how the updated ISO 10993-1 impacts biological risk assessments, gap analysis, documentation, and compliance for medical devices.
Discover the truth behind the “Anvisa bans fiberglass nails” topic and explore other important regulatory updates.
Learn how to navigate the Anvisa medical device registration process and bring your product to the Brazilian market with confidence.
Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE consultation!
Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.
Finding the correct technical name for your IVD in Anvisa’s database can be challenging. Learn how to do it!
Learn how in vitro testing cosmetics provides ethical and scientifically relevant methods to ensure safety without animal testing.
What is In Vitro Diagnostics? Discover how IVDs play a vital role in healthcare, the key applications, regulatory pathways, and more.
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help you meet FDA compliance.
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
Learn how to conduct Biological Evaluations for Medical Devices using ISO 10993. Follow essential guidelines to ensure safety and compliance.
Explore best practices for Clinical Evaluation for SaMD under MDR 2017/745 to streamline the process and ensure compliance.
MDSAP in Canada is key to your medical device's success, ensuring compliance, smooth market entry, and adherence to regulatory standards.
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
Toxicological risk assessment in medical devices plays an important role in ensuring safety and evaluating potential hazards.
Learn how the Modernization of Cosmetics Regulation Act (MoCRA) transforms industry standards and how to achieve FDA compliance.
Learn how to register cosmetic products under the EU Cosmetics Regulation. Ensure compliance and safe market entry in the European Union!
Explore the essential steps and best practices for conducting an internal audit of medical devices. Ensure compliance with expert tips!
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