Introduction The process of bringing a medical device to market in the United States involves stringent regulations imposed by
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https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s
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Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating
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*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under
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Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices
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Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
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Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an
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Are you a medical device manufacturer looking to enter the Canadian market? Navigating the regulatory landscape can be overwhelming,
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Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the terms
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In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers
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Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs
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Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s strict
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The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to
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The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023 begins
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Looking for a quality import service can be a daunting task, but with the right advice and tips, you can
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What are Class 1 Medical Devices? Class 1 medical devices are the lowest risk category of medical devices, as
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Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose, treat,
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Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it
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Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the
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Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients.
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Navigating the medical device regulations set by Health Canada can be a complicated task, but knowing the specific classification
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The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device
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The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical devices.
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Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The
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In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
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On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
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Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
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Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
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Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
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The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes
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It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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Who Needs an MDSAP Certificate? Anyone looking to manufacture a Class II, III or IV medical device in Canada requires
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Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
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Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
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As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
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Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is
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Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings,
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Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and
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