EUA FDA Transition Plan for Medical Devices in 2022

Medical devices Standards EUA

In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations (EUA). This measure by the FDA was designed to mitigate the stress on the device supply chain and the associated scarcity of certain devices that are critical to the prevention and management of Covid-19. So

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Top 6 Questions to ask about OTC Drugs

OTC Drugs

1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can be bought without a doctor’s prescription. OTC drugs can include things like hand sanitizer, sunscreens, cold & flu medication, and medicated topical products such as skin treatments, lip ointment, and anti-fungal creams. 2. What licensing

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Learn how to differentiate Dietary Supplement vs NHP Labeling

NHP Labelling

Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products can be classified as both. But not all dietary supplements are natural health products and vice-versa. There are some distinct classification factors for each. Generally, dietary supplements are labeled comparably to food products in the

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Cosmetic Notification Form: A Step-by-Step Guide to Stay Compliant in Canada

Health Canada cosmetic notification form guide for Canadian manufacturers

Filling out a Cosmetic Notification Form is a required step before selling any cosmetic product in Canada. Health Canada uses this form to monitor ingredients, verify product safety, and ensure compliance with the Food and Drugs Act and Cosmetic Regulations.  While the process can seem confusing at first, it becomes simple once you understand what

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