510k Requirements

Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new...

Are you ready to introduce your infant formula to the Canadian market? Health Canada’s stringent regulations ensure the safety, quality,...

Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD)...

Introduction  Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing...

Navigating Health Canada’s drug submission pathways can be daunting. How do you know which pathway—ANDS, SNDS, or NDS—best suits your...

Navigating Canada’s pharmaceutical regulations can be overwhelming for businesses, especially those dealing in food products, ingredients, and additives. Two pivotal...

FDA User Fees for Fiscal Year 2025 (FY2025) The FDA’s user fees for FY2025, which runs from October 1, 2024,...

Simplified Explanation of Changes to Labeling Rules  Starting July 2022, food manufacturers and suppliers have been required to display special...

GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and...

The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg...

The NNHPD Opens Consultation on Batch 4  Through new guidelines, stakeholders are invited to shape the future of homeopathic and...

Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter...

Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental...

Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic...

  Regulatory Considerations when Selling Foods and Beverages in the United States  Selling food products in the United States requires...

Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT)  On August 22, 2024, the Honourable Mark Holland, Minister of Health,...

How to Create Health Canada Compliant Food Labels  When entering the Canadian market, designing your food labels correctly is not...

The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction...

This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been...

The Modernization of Cosmetics Regulation Act (MoCRA) brings significant changes for everyone in the cosmetics industry, from manufacturers to distributors....

Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and...

Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This...

We understand the impact of changing Amazon Canada regulations on your business – and how non-compliance can hurt you. Q:...

FDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical...

Remember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid...

Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard...

When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The...

Introduction The process of bringing a medical device to market in the United States involves stringent regulations imposed by the...

https://youtu.be/dVbug89UHBA Introduction In food safety management, Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that ensures the...

Navigating the intricate landscape of food and food additive regulation in the United States involves understanding the GRAS concept – “Generally...

Are you curious about GRAS substances? Look no further! This comprehensive guide takes you from A to Z, covering everything...

Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer...

https://youtu.be/E0E0dohMpC4 So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk...

https://youtu.be/QABD-2XIRz0 Canada is known for its diverse culinary landscape. If you’re considering selling food products in this country, you’re in...

Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness....

The pharmaceutical industry ensures public health by developing, manufacturing, and distributing safe and effective medications. For any drug to be...

Introduction  In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy...

Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a...

Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for...

  As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory...

https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting...

Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC)...

https://youtu.be/uuXA8yHrrZc Introduction: In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products,...

https://youtu.be/x4c0LEPmJuM If you’re selling food products in the United States, understanding and complying with FDA regulations is non-negotiable. The Food...

Introduction:  Health Canada’s Natural Products Number (NPN) application process is vital for manufacturers and distributors of natural health products (NHPs)...

Introduction:  Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,...

https://youtu.be/rxz4HJOd6-M You’re about to step into a regulated industry designed to ensure the safety and quality of products. To successfully...

Introduction:  For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority....

*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the...

https://youtu.be/T3pLp1dF08Y The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than...

https://youtu.be/T3pLp1dF08Y Introduction:  In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products...

  From FDA guidelines to global regulatory standards, understanding the nuances of each requirement is essential to ensure a timely...

In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets...

  Introduction:  So you’ve got a game-changing medical device that could reshape healthcare as we know it. Amazing! But before...

https://youtu.be/dVbug89UHBA In today’s fast-paced and diverse industries, pursuing safety and quality isn’t just a goal; it’s a non-negotiable commitment. This...

Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul...

https://youtu.be/mWaBQzsa1_M Introduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex....

Understanding Food Labels: A Simple Guide Food labels are more than just ingredient stickers on packaging; they are a key...

Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices...

Health Canada, the Canadian federal health department, oversees the regulation of controlled substances in Canada. Controlled substances are regulated due...

The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety...

Quality Management Systems (QMS) are an essential part of the life sciences healthcare industry, and many people need clarification on...

Are you ready to take your business to new heights? Look no further. In this comprehensive guide, we will unlock...

Health Canada publishes product monographs to describe a product’s health risks, benefits, and performance. Product monographs are for health products...

  Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of...

Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and...

Introduction: The European Food Safety Authority (EFSA) provides regulatory guidance and oversees the approval process for novel foods in the...

Navigating the complex medical device regulatory process can often feel like decoding a cryptic language. Manufacturers grapple with an intricate...

Food manufacturers everywhere are willing to jump through hurdles to receive their GRAS Notifications and access to the generally recognized...

https://youtu.be/uuXA8yHrrZc Introduction: Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29, 2022. This...

This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA....

Are you looking to bring your natural health product to market? Navigating the process of obtaining a license can be...

In today’s rapidly evolving regulatory landscape, businesses face many challenges regarding ensuring compliance and product safety. One crucial aspect often...

  Are you a medical device manufacturer looking to enter the Canadian market? Navigating the regulatory landscape can be overwhelming,...

Are you a health and wellness entrepreneur looking to bring your products to the Canadian market? Navigating the Health Canada...

Are you ready to break new ground in healthcare and drug testing? Opening a drug testing facility can be challenging...

Are you looking to tap into the immense potential of the Canadian market and boost your e-commerce success? Look only...

In the dynamic and ever-evolving world of pharmaceuticals, ensuring compliance with FDA regulations is paramount. One crucial aspect that must...

  Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the...

In a world where culinary boundaries are constantly expanding, the future of food holds endless possibilities. Enter EFSA Novel Foods,...

  In today’s global economy, businesses increasingly use international trade to source materials and sell products. However, the complex regulations...

Introduction: Quality assurance is an essential part of clinical trials. It involves a set of processes that ensure that the...

Introduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both...

  As a researcher, you know that the success of your study depends on many factors, from the quality of...

As the saying goes, prevention is always better than a cure. This is particularly true regarding food safety in the...

As a company developing new products, ensuring they are safe for consumption is essential. One way to achieve this is...

Food safety is a top priority for Canadians. With so many potential hazards lurking in our food supply, it’s more...

Consumers are becoming more discerning about their food in today’s increasingly health-conscious society. They want to know that their products...

https://youtu.be/mWaBQzsa1_M Introduction In the world of international trade, importers of record play a crucial role in ensuring smooth customs clearance...

https://youtu.be/cct8v4aXvhc In the fast-paced and ever-evolving world of pharmaceuticals, staying ahead of the competition is crucial. And one vital tool...

https://youtu.be/dVbug89UHBA Welcome to a comprehensive Hazard Analysis and Critical Control Points HACCP process exploration. In today’s world, ensuring the safety...

  Non-Conformance Reports Introduction: In today’s fast-paced and competitive business landscape, identifying and resolving issues is crucial for maintaining the...

Introduction to Cosmetic Regulations by the FDA: Are you a cosmetics brand looking to navigate the complex world of FDA...

When thinking about NDI Classification have you ever heard about the New Dietary Ingredient Notification in Ingredient Compliance? In today’s...

Are you a business owner in the health and wellness industry looking to navigate the complex regulatory landscape in Canada?...

In marketing, the power of persuasive structure-function claims cannot be underestimated. Regarding consumer perception and product sales, structure-function claims have...

In a world where the pharmaceutical industry is constantly evolving and new drugs are being introduced to the market every...

Are you a food, beverage, drug, or cosmetics business owner?If so, you already know how crucial it is to comply...

Introduction: Welcome to the ultimate guide to conducting a successful clinical trial, where we will delve into the best practices...

The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post...

In today’s competitive marketplace, selling products on Amazon has become a lucrative opportunity for many entrepreneurs and businesses. However, navigating...

https://youtu.be/iVJlCZmDeWU In today’s highly competitive food industry, ensuring the safety and quality of products is of utmost importance. One key...

In this blog, we discuss the benefits, challenges, steps, and opportunities a medical device establishment license can offer manufacturers and...

Are you a company in the healthcare or pharmaceutical industry looking to bring a new product to market? If so,...

In the ever-evolving healthcare landscape, staying up-to-date with the latest regulations and requirements is crucial for health professionals. And when...

https://youtu.be/mWaBQzsa1_M Introduction Welcome to a fascinating journey through the world of imported foods in Canada, where flavors from all corners...

Are you a business owner in the health and wellness industry? If so, you’re likely familiar with Health Canada’s Natural...

Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and...

  The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition...

The healthcare industry is constantly evolving, and with the introduction of new technologies, it is becoming more efficient and effective...

Consumers rely on Health Canada monographs to ensure the safety and efficacy of their products. But have you ever wondered...

Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict...

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...

As more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on...

  Medical devices play a crucial role in modern healthcare, providing patients with life-changing treatments and improving the quality of...

As a business owner in the medical industry, you understand the importance of providing quality products and services to your...

https://youtu.be/mtmJgcfh9gI   If you are planning to, import, distribute, or sell medical devices in Canada or manufacture Class I medical...

Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must...

In today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public health...

The healthcare industry is constantly evolving, and one of the most significant advances has been implementing drug identification numbers (DINs)....

Importing goods from other countries can be a lucrative business and a complex and tedious process. As an importer, you...

As a medical device manufacturer, getting your product to market can be a complex process with various regulatory requirements to...

Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products...

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...

In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission...

Health Canada has the authority to set and charge health product fees under the Food and Drugs Act (FDA). On...

https://youtu.be/dVbug89UHBA The food industry has undergone a significant transformation in terms of safety and quality control over the years. From...

What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies...

Are you considering getting your food safety certification? In today’s highly competitive food industry, ensuring your food products are safe...

https://youtu.be/dVbug89UHBA HACCP (Hazard Analysis and Critical Control Points) certification is a food safety management system that helps businesses identify and...

  As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns...

https://youtu.be/iVJlCZmDeWU Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance....

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,...

Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product...

https://youtu.be/iVJlCZmDeWU Introduction: If you’re a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process...

https://youtu.be/NN8ZLynq6kE If you work in the food service industry, you may need to obtain food handlers license to ensure that...

https://youtu.be/wOKeuDAEfss Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)?...

https://youtu.be/dVbug89UHBA In the food industry, ensuring the safety of the products you produce is of utmost importance. One key aspect...

  As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the...

BRC certification is a globally recognized standard for food safety and quality management. In Canada, it is becoming increasingly important...

https://youtu.be/mWaBQzsa1_M Introduction Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements....

https://youtu.be/wOKeuDAEfss Have you ever wondered what goes into the food you eat every day? Various food additives enhance our food’s...

Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to...

Navigating the complexities of the  regulatory requirements for dietary supplements  can be daunting. However,  by understanding the framework, you can...

https://youtu.be/iVJlCZmDeWU GRAS certification is an important step for any manufacturer who wants to market a food or food-related product. By...

Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs...

  Introduction: Manufacturing and selling medical devices in Canada can be a complex process and requires adherence to Health Canada’s...

As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal...

Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and...

The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the...

  The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023...

Introduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have...

https://youtu.be/dVbug89UHBA Introduction: Food safety is an important part of any food business. It’s also a complicated one. There are many...

  The Licensing and Non-paired Health Products Directorate (LNHPD) is a federal government organization that oversees the regulation of natural...

Looking for a quality import service can be a daunting task, but with the right advice and tips, you can...