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Ensuring Predictability for Interim Orders Relating to COVID-19
Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is showing the understanding from Health Canada that...
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Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements
Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review RequirementsOn May 27, 2021 Health Canada issued a bulletin about cancellation of Medical Device...
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Public Consultation on Medical Devices Clinical Trials Modernization Initiative
Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug, medical devices and natural health products (NHPs). The purpose of...
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Public Consultation on Medical Devices Unique Device Identifier Initiative
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices in Canada. This is Health Canada’s first consultation on the UDI system...
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Top 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), have...
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Clearing Regulatory Hurdles with a 510K Premarket Notification
Submitting a 510K Premarket Notification is an essential step in the process of getting medical devices approved by the FDA. This notification includes detailed information about the device and its...
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Understanding Class 1 Medical Devices Approval & Importance
What are Class 1 Medical Devices?Class 1 medical devices are the lowest risk category of medical devices, as they are considered to have a low potential for harm to the user. These devices are...
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How to comply with Health Canada Regulations for Medical Devices?
Introduction:Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s strict regulations. Understanding these regulations is essential...
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Software as Medical Devices SaMD Registration Everything you should know
As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the healthcare industry. SaMD refers to software that is intended for medical purposes,...
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The ultimate regulatory guide to importing products into Canada
If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a viable option. However, navigating the regulations and requirements for importing goods...
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Ultimate FDA Establishment Registration guide for your business
Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must know the FDA establishment registration requirements to ensure your products...
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The ultimate guide to obtaining a Medical Device Establishment Licence
If you are planning to, import, distribute, or sell medical devices in Canada or manufacture Class I medical devices in Canada, you must have a Medical Device Establishment Licence. This guide will...
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Why your business should have a trusted Medical Device Importer?
As a business owner in the medical industry, you understand the importance of providing quality products and services to your customers. When it comes to medical devices, ensuring they are safe and...
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Class 2 Medical Devices: Unlocking compliance requirements
Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of life for millions worldwide. However, the development and...
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FDA guidance for EUA medical devices transition under PHE policies
The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition away from specific procedures and policies put in...
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The Ultimate PMA Submissions Guide: The Importance of Proper Documentation
Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and submitting a PMA (Pre-Market Approval) is complex and requires a...
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What Health Businesses Should Know About Health Canada Fees?
In the ever-evolving healthcare landscape, staying up-to-date with the latest regulations and requirements is crucial for health professionals. And when it comes to navigating the complex world of...
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6 steps to earn your Medical Device Establishment License (MDEL)
In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and business owners that distribute medical devices. Let’s...
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The Importance of Amazon Seller Compliance: How to Avoid Penalties and Boost...
In today’s competitive marketplace, selling products on Amazon has become a lucrative opportunity for many entrepreneurs and businesses. However, navigating the online retail world comes with...
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Decoding the Jargon: Medical Device approvals 510(K) V.S. PMA differences &...
Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the terms 510(k) and PMA regarding medical devices. But what do these terms mean, and...
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