The U.S. Food and Drug Administration (FDA) has issued notifications raising FDA data integrity concerns about medical device testing labs, signaling that the
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The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k) premarket notification requirements, formally
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Health Canada has officially eliminated the finished product specification (FPS) submission requirement for Class II and Class III NHP product licence applications, streamlining the
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The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the
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Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in
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The U.S. Food and Drug Administration announced on May 6, 2026, that it is piloting a new class of shorter,
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On May 12, 2026, the U.S. Food and Drug Administration finalized its new food chemical safety assessment program and simultaneously launched formal
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Health Canada has confirmed it is moving forward with amendments to NHP labelling requirements in Canada, with draft regulations now
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On May 11, 2026, the U.S. Food and Drug Administration published its latest update to the Over-the-Counter Monograph Drug User
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The U.S. Food and Drug Administration published a notice in the Federal Register on May 1, 2026, announcing its intent
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Health Canada has published its first prebiotic monograph, providing long-awaited regulatory clarity for natural health products containing prebiotic ingredients. If
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If your company holds or is applying for an NHP site licence, the way you send submissions to Health Canada has
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As of January 2026, Health Canada’s Regulatory Enrolment Process (REP) is mandatory for all Class II, III, and IV medical device licence (MDL)
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Health Canada issued updated versions of both its Primary Sunscreen Monograph and Secondary Sunscreen Monograph on December 19, 2025, replacing the versions
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When Health Canada amended the Cosmetic Regulations to introduce fragrance allergen disclosure requirements, the industry pushed back fast. The fragrance
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If you manage regulatory submissions for natural health products, you likely already know that Health Canada ends FSRN acceptance as of February 16, 2026. Health Canada announced this change through Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10.
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Health Canada is moving to answer a question the industry has been pressing for years: why should Canada conduct a
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Missing your MDEL renewal deadline puts your entire Canadian market access at risk. Under the Medical Devices Regulations (SOR/98-282), all Medical Device
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In a letter issued February 5, 2026, the U.S. Food and Drug Administration (FDA) said it intends to exercise enforcement
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Health Canada has opened a public consultation on a new prebiotics monograph, with stakeholder feedback accepted until February 20, 2026. The
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