How to Build a Medical Device QMS That Meets FDA QMSR Requirements
If your organization sells finished medical devices in the United States, the structure of your medical device QMS is no longer governed by the Quality
... Read moreIf your organization sells finished medical devices in the United States, the structure of your medical device QMS is no longer governed by the Quality
... Read moreStandard operating procedures for cannabis retail business operations are not optional extras. They are foundational documents that provincial regulators expect you to have in place
... Read moreIf 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.
... Read moreHealth Canada is moving to answer a question the industry has been pressing for years: why should Canada conduct a full independent review of a
... Read moreMissing your MDEL renewal deadline puts your entire Canadian market access at risk. Under the Medical Devices Regulations (SOR/98-282), all Medical Device Establishment Licence holders must complete their Annual Licence Review
... Read moreIn a letter issued February 5, 2026, the U.S. Food and Drug Administration (FDA) said it intends to exercise enforcement discretion when food manufacturers use
... Read moreHealth Canada has opened a public consultation on a new prebiotics monograph, with stakeholder feedback accepted until February 20, 2026. The draft guidance, released by the
... Read moreHealth Canada has confirmed that Sports Electrolyte Supplements will be reclassified under a single regulatory framework, marking a significant change for products currently regulated as either natural
... Read moreOn January 23, 2026, the U.S. Food and Drug Administration (FDA) announced new actions aimed at improving how a gluten ingredient is disclosed on food labels. The update, released on January
... Read moreThe U.S. Food and Drug Administration (FDA) has released its priority deliverables for 2026 under the Human Food Program, outlining where the agency plans to
... Read moreIf you are preparing to launch a new ingredient or food product in Australia or New Zealand, one of the first regulatory questions you need
... Read moreThinking about launching a new food ingredient in the U.S. often raises an important question: how do you demonstrate safety to the FDA without triggering a lengthy
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