News: Automatic issuance impacts Anvisa AFE consultation and more!
October 24, 2025
Anvisa has automated the issuance of certificates through the Solicita system. Learn what changes in the Anvisa AFE consultation!
Updates, guidance and expert perspectives on regulatory affairs, compliance and market access across Brazil, the United States and Europe.
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.
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help you meet FDA compliance.
Explore the essential steps and best practices for conducting an internal audit of medical devices. Ensure compliance with expert tips!
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
MDSAP in Canada is key to your medical device’s success, ensuring compliance, smooth market entry, and adherence to regulatory standards.
Explore best practices for Clinical Evaluation for SaMD under MDR 2017/745 to streamline the process and ensure compliance.
Learn how to conduct Biological Evaluations for Medical Devices using ISO 10993. Follow essential guidelines to ensure safety and 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.
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.
Proven steps for Quality Control Medical Devices and how a robust QMS aligned with ISO 13485:2016 can help you meet FDA compliance.
Explore the essential steps and best practices for conducting an internal audit of medical devices. Ensure compliance with expert tips!
Discover a step-by-step guide to FDA medical devices approval, outlining the process, requirements, and key considerations for manufacturers.
MDSAP in Canada is key to your medical device’s success, ensuring compliance, smooth market entry, and adherence to regulatory standards.
Explore best practices for Clinical Evaluation for SaMD under MDR 2017/745 to streamline the process and ensure compliance.
Learn how to conduct Biological Evaluations for Medical Devices using ISO 10993. Follow essential guidelines to ensure safety and compliance.
Subscribe to our newsletter to receive the latest updates and insights.
You may unsubscribe at any time using the link in our newsletter.