Are you a business owner in the health and wellness industry? If so, you’re likely familiar with Health Canada’s Natural
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Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and
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The healthcare industry is constantly evolving, and with the introduction of new technologies, it is becoming more efficient and effective
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Consumers rely on Health Canada monographs to ensure the safety and efficacy of their products. But have you ever wondered
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Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
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https://youtu.be/mWaBQzsa1_M If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a
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As more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on
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Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of
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As a business owner in the medical industry, you understand the importance of providing quality products and services to your
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https://youtu.be/mtmJgcfh9gI If you are planning to, import, distribute, or sell medical devices in Canada or manufacture Class I medical
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Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must
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In today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public health
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The healthcare industry is constantly evolving, and one of the most significant advances has been implementing drug identification numbers (DINs).
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Importing goods from other countries can be a lucrative business and a complex and tedious process. As an importer, you
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As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to
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https://youtu.be/mWaBQzsa1_M If you’re a business owner looking to expand your reach into the Canadian market, importing products may be a
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In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission
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Health Canada has the authority to set and charge health product fees under the Food and Drugs Act (FDA). On
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https://youtu.be/dVbug89UHBA The food industry has undergone a significant transformation in terms of safety and quality control over the years. From
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Are you considering getting your food safety certification? In today’s highly competitive food industry, ensuring your food products are safe
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https://youtu.be/dVbug89UHBA HACCP (Hazard Analysis and Critical Control Points) certification is a food safety management system that helps businesses identify and
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As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns
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https://youtu.be/iVJlCZmDeWU Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance.
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https://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However,
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https://youtu.be/iVJlCZmDeWU Introduction: If you’re a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process
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https://youtu.be/NN8ZLynq6kE If you work in the food service industry, you may need to obtain food handlers license to ensure that
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https://youtu.be/wOKeuDAEfss Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)?
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https://youtu.be/dVbug89UHBA In the food industry, ensuring the safety of the products you produce is of utmost importance. One key aspect
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As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the
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BRC certification is a globally recognized standard for food safety and quality management. In Canada, it is becoming increasingly important
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https://youtu.be/mWaBQzsa1_M Introduction Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements.
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https://youtu.be/wOKeuDAEfss Have you ever wondered what goes into the food you eat every day? Various food additives enhance our food’s
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Navigating the complexities of the regulatory requirements for dietary supplements can be daunting. However, by understanding the framework, you can
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https://youtu.be/iVJlCZmDeWU GRAS certification is an important step for any manufacturer who wants to market a food or food-related product. By
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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
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As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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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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The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the
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Introduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have
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https://youtu.be/dVbug89UHBA Introduction: Food safety is an important part of any food business. It’s also a complicated one. There are many
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The Licensing and Non-paired Health Products Directorate (LNHPD) is a federal government organization that oversees the regulation of natural
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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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https://youtu.be/dVbug89UHBA The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that
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Introduction: Are you looking to get GMP certification for your business? Getting certified is a process that involves understanding and
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Introduction: Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling,
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Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market
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Introduction: Navigating the intricate web of medical device regulations can be daunting for businesses unfamiliar with the regulatory landscape.
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Introduction: If you are wondering what foods and substances the FDA considers to be Generally Recognized As Safe (GRAS), you have
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Introduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements
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Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes
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Introduction: FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government
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https://youtu.be/XRZ87ifRki0 Introduction: The Global Food Safety Initiative (GFSI) is an international organization that sets standards for food safety and quality
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Introduction: There are many reasons that you might want to get licensed as a food processor or retail operator. You
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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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https://youtu.be/dVbug89UHBA Are you looking to get certified in the Hazard Analysis and Critical Control Points (HACCP) system? The purpose of
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Introduction Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how
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Introduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers
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https://youtu.be/XRZ87ifRki0 The Global Food Safety Initiative: What You Need to Know: The Global Food Safety Initiative (GFSI), founded in 2000,
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Introduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is
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Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list
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Introduction: Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business.
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Introduction Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program.
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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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Introduction to GRAS & NDI An ingredient can get into the diet by being a food, food additive, drug, dietary
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https://youtu.be/dVbug89UHBA HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the
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Food is one of the most important parts of our lives. We eat it to stay alive, and we eat
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Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
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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 Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF) Canada is one of the most popular tourist destinations in the
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Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key
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Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
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The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to
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Foreign Supplier Verification Program (FSVP) Due to the increasingly global nature of today’s industry, an increasing number of businesses
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The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical
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Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without
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The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company
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Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems.
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Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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https://youtu.be/XRZ87ifRki0 Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a
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https://youtu.be/iojmXU4ZSx4 What is Natural Health Products Ingredients Database (NHPID)? The Natural Health Products Ingredients Database (NHPID) is an electronic tool
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https://youtu.be/O7GbA-Awo0g 1. What is the NHP Licensing Process/what is needed for it? This process involves the submission of a product
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In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they
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Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
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https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
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Do you want to learn about the food regulations for food sales in North America? This could include food facility
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Who needs a Foreign Site Reference Number (FSRN)? For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located
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As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on
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This blog unpacks the distinctions between NHPs, Health Canada & FDA-approved drugs, and cosmetic product regulations that define these products.
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Ever wonder why Why Food Labels are Important? Food labels provide important information about the food we eat, such as
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What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
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Introduction: The market for animal and pet products is growing at a rapid pace. With that, there is also a
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What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What
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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
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Introduction Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products
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Are you a cosmetics manufacturer or distributor looking to navigate the complex world of regulatory compliance? Look no further
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