News: FDA and AI-Powered Medical Devices
April 27, 2026
Learn more about the FDA’s regulatory framework for AI-powered medical devices and other global recent updates.
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
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 evaluation. Although
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
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.
Learn how to navigate the Anvisa medical device registration process and bring your product to the Brazilian market with confidence.
Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help you meet FDA compliance.
Key changes for your biocompatibility strategy.
A practical guide to understand the 2025 update and what it means for your medical device documentation.
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,
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
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 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,
Understand the concept of regulatory reliance and how initiatives from IMDRF, FDA, and Anvisa are impacting global regulation.
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.
Learn how to navigate the Anvisa medical device registration process and bring your product to the Brazilian market with confidence.
Malaysia joins MDSAP, expanding global audits. Plus: FDA software guidance, IMDRF PCCP guideline, and Anvisa’s new import process.
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help you meet FDA compliance.
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