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What is a US Agent for FDA registration and why is it essential for medical devices?
Entering the U.S. medical device market can be a major
January 8, 2026No Comments
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Entering the U.S. medical device market can be a major
The FDA has published a new guideline aligned with ICH
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.
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