Health Canada to Reduce Red Tape: What It Means for Your Business
Learn how Health Canada red tape reduction initiatives may affect businesses. Stay informed on regulatory updates and compliance changes.
... Read moreDe Minimis Rule Ending: What Businesses Must Know
The de minimis rule is ending in the U.S. Learn what this means for compliance, shipping costs, and your regulatory strategy.
... Read moreWhat You Need to Know About GMP Training
Learn what GMP training is, why it matters, and who needs it. Explore GMP fundamentals and compliance requirements for Health Canada and FDA.
... Read moreWhat the New FDA PreCheck Program Means for Drug Manufacturers
FDA PreCheck program aims to boost U.S. drug manufacturing. Learn how it could impact domestic pharmaceutical facilities and compliance steps.
... Read moreFDA Proposes Compliance Extension And Releases New Tools For Food Traceability
FDA food traceability compliance date may be extended. Learn about the August 2025 proposal, updated FAQs, and tools to prepare your business.
... Read moreHow to register your private label medical device in Canada
Learn how to register a private label medical device with Health Canada. Follow this step-by-step guide to ensure regulatory compliance.
... Read moreFDA Releases New Chemical Screening Tool for Food Safety
FDA’s new EDT tool helps screen chemicals in food for toxicity. Learn how it supports safer food and faster evaluations.
... Read moreSenators Propose Bill To Eliminate Self-affirmed GRAS Loophole
Learn how a new bill may eliminate self-affirmed GRAS and what it means for food ingredient compliance. Stay ahead with expert support.
... Read moreHow the SAFE Sunscreen Act Could Change FDA Compliance
Learn how the SAFE Sunscreen Standards Act could impact sunscreen compliance and FDA approvals.
... Read moreAre you meeting Health Canada’s site license renewal requirements?
Over the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in site license suspensions or renewal refusals. Health Canada is reinforcing its compliance expectations and taking action where gaps are found. If your site license renewal is coming up, this is the time to double-check your
... Read moreHealth Canada issues interim report on sodium targets for processed food
Introduction Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard consumer health and meet Health Canada’s 2025 targets. Too much sodium raises blood pressure and increases the risk of heart disease and stroke, which are among the leading causes of death in Canada. In December
... Read moreComparing FDA 510(k) and PMA Pathways for Medical Devices
When preparing to launch a medical device in the U.S., one of the first and most important decisions
... Read moreBoosting Business Operations Through GMP Training
If you work in the life sciences industry, you’ve likely heard of GMP, Good Manufacturing Practice. It’s a fundamental part of producing safe, effective, and high-quality products.
... Read moreThe Role of Audits in Meeting Health Canada’s Compliance Standards
When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list. It helps you maintain your licence, protect your brand, and stay competitive in a regulated market. If you hold a Drug Establishment Licence (DEL), Medical Device Establishment Licence (MDEL), or a Natural Health Product (NHP)
... Read moreHow to Comply with the FDA’s NDI Notification Process
Learn how to meet FDA’s new dietary ingredient notification requirements for dietary supplements with new educational tools.
... Read morePet Supplements or Veterinary Health Products? Understanding the Difference
Compare pet supplements vs veterinary health products to stay compliant in the U.S. and Canada. Know the rules and get expert help to launch successfully.
... Read moreA Guide to Securing an NPN for Hydration Products in Canada
Learn how to get an NPN for hydration products in Canada and ensure full Health Canada compliance.
... Read moreGRAS for Food vs. Feed: Understanding the Key Differences
Understand the GRAS process for human food vs. animal feed and how to stay compliant with FDA regulations.
... Read moreTraditional Cosmetics vs. Cosmeceuticals: What’s the Difference?
Learn the key differences between traditional cosmetics and cosmeceuticals to ensure regulatory compliance in Canada and the U.S.
... Read moreA Guide to the SFCR Importer of Record Role
Learn what an SFCR importer of record is and how CARM changes affect food importers in Canada. Stay compliant with expert support.
... Read moreMDL vs. MDEL: Understanding Canada’s Medical Device Licensing
Learn what MDL and MDEL mean, how they differ, and how to stay compliant with Health Canada regulations.
... Read moreStruggling With GRAS Compliance? Here’s What to Do
Learn what to do if you’re struggling with the GRAS compliance process. Follow these tips to avoid delays and meet FDA standards.
... Read moreFDA Approves Natural Food Colors for Safer Use
FDA approves three food colors from natural sources, offering safer alternatives to petroleum-based dyes. Learn how this impacts your food products.
... Read moreFDA Unannounced Inspections: What Foreign Manufacturers Need To Know
FDA expands unannounced inspections for foreign sites. Learn what this means and how to stay compliant.
... Read moreHealth Canada electronic filing updates: Key changes in 2025
Health Canada’s update changes how drug product submissions must be filed. Learn what’s new and how to stay compliant.
... Read moreNavigating FDA and Health Canada Rules for Eczema Products
Understand how to stay compliant with FDA and Health Canada rules for eczema products. Learn how to properly classify and register your product.
... Read moreComparing Cosmetic Compliance Standards: FDA and Health Canada
Learn the key differences between FDA and Health Canada cosmetic compliance to meet regulatory requirements and avoid costly setbacks.
... Read moreHealth Canada’s April 2025 Updates on the Medical Device Shortage List
Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed.
... Read morePreparing a Successful Food Additive Submission in Canada
Learn how to prepare a food additive submission for Health Canada to ensure compliance and avoid costly delays.
... Read moreTips to Keep Cosmetics Compliant and Listed on Amazon Canada
Learn how to avoid Amazon Canada cosmetic delisting by meeting Health Canada requirements and maintaining compliance.
... Read moreFDA announces ESG NextGen launch for industry submissions
FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now use this updated system instead of the retired WebTrader platform.
... Read moreEFSA Opens 2025 Call for Novel Food Advice to SMEs
EFSA is offering early advice to SMEs preparing novel food applications in 2025. Apply before the June 12 deadline to get guidance.
... Read moreWhat’s the Difference Between Functional Foods and NHPs?
Learn the difference between functional foods and Natural Health Products in Canada, and how to classify your product correctly.
... Read moreThe Role of Natural Product Numbers (NPNs) in Canada
What is NPN? Learn how to get approval for your natural health product and stay compliant with Canadian regulations.
... Read moreFood and Supplement Labeling: Canada vs US Requirements
Understand food and supplement labeling differences between Canada and the US to stay compliant and avoid costly delays.
... Read moreFDA Releases Cosmetic Facility & Product Registration Summary
FDA releases registration and listing data for cosmetic facilities and products under MoCRA. Learn what this means for your compliance.
... Read moreFDA to Extend Food Traceability Rule: What You Need to Know
The FDA plans to extend the Food Traceability Rule compliance date by 30 months. Find out how this impacts your compliance strategy.
... Read moreHealth Canada Announces Amendments to Cannabis Regulations
Health Canada updated cannabis regulations on March 12, 2025. Learn about compliance, cost-saving benefits, and industry impact.
... Read moreHealth Canada Proposes Changes to Caffeine as a Supplemental Ingredient
Health Canada proposes modifications to caffeine use in supplemented foods. Learn how this impacts compliance and product formulation.
... Read moreSelf-Affirmed GRAS May End – What It Means for You
The FDA may eliminate self-affirmed GRAS. Learn how this change could affect food ingredient approvals and what steps you should take now.
... Read moreFDA’s New AI Rules for Medical Devices: What’s Changing?
The FDA just updated its AI rules for medical devices. Learn what’s changing, how it will impact your business, and stay ahead of compliance updates.
... Read moreNHP Labelling: Ministerial Exemption Order Announced
Health Canada announces a Ministerial Exemption Order for NHP labelling regulations, delaying new compliance requirements until June 21, 2028.
... Read moreIs Your Cosmetic Ready for Canada’s New Allergen Rules?
Health Canada’s fragrance allergen rules take effect April 12, 2026. Ensure your cosmetic products comply with new labelling regulations.
... Read moreHealth Canada’s New Front-of-Package Label Rules Explained
Health Canada’s new front-of-package label rules take effect on January 1, 2026. Learn how to comply and avoid penalties.
... Read moreHow to Make ‘Made in Canada’ Claims Amid Trade Tensions
Learn how to navigate ‘Made in Canada’ claims to stay compliant and competitive amid changing trade regulations.
... Read moreNavigating the TGA Approval Process for New Substances
Discover the key steps to obtaining TGA approval for new substances in listed medicines. Ensure compliance and streamline your application.
... Read moreA Practical Compliance Guide to Shilajit and FDA Rules
Learn how to navigate the FDA approval process for shilajit in 5 simple steps. Follow our expert guide for a smoother regulatory journey.
... Read moreUnderstanding Health Canada’s Approval on Grape Seed Extract in Foods
Discover Health Canada’s decision to allow grape seed extract in foods and how it impacts the industry.
... Read moreWhy Are FDA Food Contact Notifications No Longer Effective?
Learn why some FDA Food Contact Notifications are no longer effective and how to ensure compliance with updated regulations.
... Read moreWhat Are FDA Medical Device Classes?
Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing how the FDA medical devices are categorized can help you avoid setbacks and ensure compliance, whether you’re dealing with a simple tool or a life-saving implant. But how exactly does the FDA determine a device’s
... Read moreHealth Canada Fees 2025 Guide
Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
... Read moreHealth Canada’s New Nicotine Rules: What’s Changing in 2024
If you’re in the business of nicotine replacement therapies, major regulatory changes are now in place.
... Read moreHow to Prepare for an FDA 510(k) Pre-Submission
Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find themselves wondering where to start, what’s required, and how to get FDA approval for their medical devices. Without a clear plan, it’s easy to waste time and money on unnecessary
... Read moreHow to Ensure Compliance with Canada’s Infant Formula Registration
Learn how to navigate Canada’s strict infant formula registration process and ensure full compliance with Health Canada’s regulations.
... Read moreHealth Canada Opens 75-Day Consultation on Batch 4b – Share Your Input
Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD) invites industry stakeholders to provide feedback on Batch 4b, with consultation open for 75 days. We encourage you to support any suggestions for monograph revisions with published evidence or clear rationale. What’s Included in Batch
... Read moreHow to Master FDA Audits for Your Dietary Supplement Facility: A Complete Preparation Guide
Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing Practices (GMP) requirements. The FDA regularly inspects dietary supplement facilities to ensure manufacturing, labeling, and safety regulations compliance. But how can you ensure you’re ready? Failing to meet FDA standards can lead to severe consequences,
... Read moreHealth Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?
This article breaks down the 3 main pathways for drug submission in Canada: NDS, SNDS & ANDS. Choose the right one for faster market & lower cost.
... Read moreHealth Canada’s Drug vs Product Monograph: Key Differences
Two pivotal documents in this regulatory landscape, the Health Canada Drug Monograph and Product Monograph, hold distinct roles and purposes. Keep reading to learn more.
... Read moreFDA Fees Summary for 2025
FDA User Fees for Fiscal Year 2025 (FY2025) The FDA’s user fees for FY2025, which runs from October 1, 2024, to September 30, 2025, apply to various industries, including pharmaceuticals, medical devices, biologics, and animal drugs. These fees help support the FDA’s regulatory and review processes, promoting efficient approval and compliance. 1. Prescription Drug User
... Read moreNew Modification to Buffer Zone Affects Food Manufacturers and Suppliers
Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special labeling symbols on certain food products. These include a front-of-package (FOP) nutrition symbol for products high in saturated fat, sugar, or sodium, and a supplemented food caution identifier (SFCI) for supplemented foods with specific health
... Read moreQuality Smart Solutions Launches GRAS Experts to Protect Against Food Safety Risks
GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and avoiding recalls In light of McDonald’s recent recall of Quarter Pounders due to E. coli contamination, the need for stringent oversight on food ingredients has never been more critical. Quality Smart Solutions has launched GRAS
... Read moreGovernment of Canada Launches Consultation on Plant-Based Egg Alternative Labelling: What Businesses Need to Know
The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg products, a critical development for businesses involved in Novel Food Products and ingredients. As the plant-based food market skyrockets, this new consultation presents both an opportunity and a challenge for companies to ensure their products
... Read moreNew Hydration Product Monographs Launched
The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and topical health products. The Natural and Non-Prescription Health Products Directorate (NNHPD) has made a significant announcement, opening a crucial consultation period for Batch 4 of their latest product monographs, including several that will impact the
... Read more7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready
Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter the European market in 2025, significant updates to the EFSA novel food regulatory framework are on the horizon, effective from February 1, 2025. These changes will affect everything from risk assessments to labelling, sustainability, and
... Read moreBreaking News: Health Canada’s New GMP Guide for Natural Health Products – Are You Ready?
Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental shift in how businesses will manufacture, package, label, and store their products. This guide introduces sweeping changes, the first since 2015, to ensure NHPs sold in Canada meet modern safety and quality standards. With updates
... Read moreUnderstanding the Key Changes to Natural Health Product (NHP) Labeling in Canada
Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic medicines. As these products play a vital role in promoting health and wellness, clear and accurate labeling is essential to ensure consumers can make informed decisions about the products they use. To strengthen consumer safety
... Read moreFDA Considerations Selling Foods in USA
Regulatory Considerations when Selling Foods and Beverages in the United States Selling food products in the United States requires compliance with various regulations to ensure consumer safety and public health. The regulatory framework is complex, involving multiple federal agencies, state laws, and industry standards. Here’s an overview of the key regulatory requirements: Federal Agencies:
... Read moreHealth Canada 2024 Changes for Nicotine Replacement Therapies (NRT)
Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) On August 22, 2024, the Honourable Mark Holland, Minister of Health, announced new measures aimed at preventing youth from being harmed by nicotine replacement therapies (NRTs). The following outlines the recent updates from Health Canada concerning NRTs. There is increasing concern that NRTs, particularly newer formats
... Read moreHow to Create Health Canada Compliant Food Labels
How to Create Health Canada Compliant Food Labels When entering the Canadian market, designing your food labels correctly is not just important—it’s critical. The Canadian food labelling landscape is complex and unforgiving, with stringent requirements that can make or break your product’s success. Quality Smart Solutions (QSS) can get your labels compliant so you can
... Read moreNew Update on FDA Sodium Reduction Efforts
The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction targets in a draft guidance, marking the launch of Phase II in their efforts. This follows Phase I, aimed at decreasing diet-related diseases associated with high sodium intake, where final voluntary sodium reduction goals were
... Read moreHealth Canada plans to share document about health products containing CBD this fall
This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been in the works since 2019. In 2022, Health Canada released a report on health products containing cannabis. Released earlier this year, The Forward Regulatory Plan for 2024 to 2026 details regulatory initiatives that Health Canada
... Read moreFDA MoCRA Compliance Guide for Cosmetic Businesses
Learn FDA MoCRA requirements for cosmetics, including registration, labeling, GMP, and safety substantiation. Stay compliant and protect your brand.
... Read moreHealth Canada’s Regulatory Plan 2024-26: Proposed Amendments to NHP and Non-Prescription Drugs
Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act. These amendments are designed to align the regulatory approach for self-care products, ensuring a streamlined and risk-based framework that reflects contemporary standards. To
... Read moreHealth Canada 2024 Drug Establishment Licensing (DEL) Update
Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This plan, divided into two phases, focuses on strengthening regulatory oversight, aligning with international standards, and easing administrative burdens. Before going into details of the update, let’s throw light on what DEL is and who needs
... Read moreHow to get an NHP Licence for Nicotine Pouches in Canada?
Remember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid release and sleek satisfaction, are rewriting the playbook. But for NHP manufacturers, the thrill of this pocket-sized revolution comes with a hefty stack of regulatory paperwork. Before you get lost in the regulatory labyrinth, let’s
... Read moreFDA Updates Yogurt Standard: Key Changes for Manufacturers
Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard of identity for yogurt, effective January 1, 2024. These updates aim to modernize regulations while maintaining the core characteristics of this beloved food. Here’s the scoop: Yogurt’s getting a modern makeover. The FDA is updating
... Read moreNavigating GRAS Panels: A Guide to Best Practices
When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The GRAS (Generally Recognized as Safe) designation plays a critical role in this process. The U.S. Food and Drug Administration (FDA) provides guidance on how to convene a GRAS panel effectively and responsibly, ensuring that the
... Read moreUnderstanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices
This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.
... Read moreCritical Control Points Explained: The Core of HACCP
Learn about Critical Control Points (CCPs) in HACCP, their role in food safety, and how to stay compliant with global regulations.
... Read moreChoosing Between GRAS Notice and Self-Affirmed GRAS
Learn the key differences between GRAS Notice and Self-Affirmed GRAS to ensure FDA compliance and food safety. Find the best approach for your product.
... Read moreUnderstanding GRAS Substances and Their Role in Food Compliance
Learn what GRAS substances are, how they’re used, and how to stay compliant. Read this guide to understand food, drug, and cosmetic regulations.
... Read moreEverything businesses should know about the Supplemented Foods Facts Table (SFFT)
Introducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer demand skyrocketing for these products, grasping the SFFT is vital for businesses looking to excel in this booming market. In this article, we’ll unravel everything you need to know about the SFFT, from its purpose
... Read moreHow Manufacturers Can Stay Compliant With Canadian Medical Device Rules
So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk about the regulatory hoops you’ll need to jump through. Selling medical devices in Canada comes with its own set of rules, and trust me, you want to be on the right side of these regulations.
... Read moreSelling Food in Canada: Navigating the Requirements for Conventional and Supplemented Products
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 for a rewarding venture. However, it’s essential to understand the specific requirements and regulations governing the sale of conventional and supplemented food items. This article will explore what it takes to sell food in Canada,
... Read moreA Guide to FDA 510(k) Clearance for Medical Devices
Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness. In the United States, the FDA 510(k) clearance process is the critical checkpoint manufacturers must pass before introducing medical devices. This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements,
... Read moreHow Drug Registration Works in the U.S. and What NDC Numbers Mean
Learn how drug registration works in the U.S. and why the National Drug Code (NDC) number matters for compliance, billing, and patient safety.
... Read moreNavigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly
Introduction In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy seas. The safety of patients, the assurance of quality, and the complexities of compliance weigh heavily on manufacturers. This article sheds light on the challenges faced and how expert navigators—regulatory consultants—play a pivotal role in
... Read moreA Clear Guide to FDA 510(k) Submission Requirements
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a critical step for manufacturers seeking clearance from the U.S. Food and Drug Administration (FDA) to market their devices. This process can be complex, but it plays a pivotal role in bringing innovative medical devices to
... Read moreNavigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers
Introduction: As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for successful market entry and consumer safety. For businesses looking to distribute food products in Canada, one essential aspect is adherence to bilingual labeling requirements, notably including French alongside English on product labels. In this blog,
... Read moreWhy is it crucial to avoid FDA Warning Letters for dietary supplements and health products?
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory landscape. Ensuring that your products meet the stringent requirements set forth by the U.S. Food and Drug Administration (FDA) is not merely a matter of legal obligation; it’s imperative for your brand’s success and consumer
... Read moreEverything businesses should know about submitting a 30-Day Pre-Market Notification and Structure-Function Claims
https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting a 30-day Pre-Market Notification and Structure-Function Claim to the U.S. Food and Drug Administration (FDA) is a pivotal regulatory requirement. This notification must be submitted at least 30 days before introducing your dietary supplement to
... Read moreHealth Canada’s Notice Enables the Use of L-alpha Glycerylphosphorylcholine in Supplemented Food
Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC) as a supplement in foods. This decision followed a thorough safety review by Health Canada’s Food Directorate. How Health Canada Administers Foods and Food Supplements Health Canada ensures food and drug safety is maintained in
... Read moreNavigating Cosmetic Product Regulations through FDA Recent MoCRA Update
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, we’ve got some updates and insights that might interest you, especially if you’re in the cosmetic business. First, nearly 50 public comments were submitted to the FDA regarding this draft guidance by the September 5,
... Read moreSelling Your Food Products in the USA: A Guide for Food Business Owners
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 and Drug Administration (FDA) has established rigorous requirements to ensure the safety and transparency of food products available to consumers. Here’s a practical guide tailored to food business owners on ensuring your food products meet
... Read moreHow to Obtain an NPN License for Your Natural Health Product in Canada
Learn how to obtain an NPN license for your natural health product in Canada with these simple steps. Stay compliant with Health Canada regulations.
... Read moreHow to prepare and submit an eStar 510k Submission as of October 1st
Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023, the FDA introduced the electronic Submission Template and Resource (eSTAR) for Pre-Submissions, revolutionizing the process for medical device applicants. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using the eSTAR template.
... Read more10 Steps to Sell Dietary Supplements in the U.S.
Learn how to legally sell dietary supplements in the U.S. by following FDA regulations, labeling requirements, and ingredient safety standards. Stay compliant and grow your business.
... Read moreUnderstanding FSVP Rules and How to Stay Compliant
For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority. The Foreign Supplier Verification Program (FSVP) is vital to this effort, requiring importers to adhere to specific rules and meticulously maintain accurate records. In this article, we’ll delve into everything importers need to know about FSVP
... Read moreWhat the Draft Guidance Means for MLMD Applications
*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the regulations, this applies to Class II, III, and IV for MLMD. It does not cover the non-ML information required in a medical device license application.* Artificial intelligence (AI) encompasses algorithms and models that perform tasks
... Read moreHow FSMA Strengthens Food Safety Compliance
The Food Safety Modernization Act (FSMA) Made Simple Imagine a world where preventing food-related illnesses is more important than dealing with them after they happen. That’s precisely what the FSMA, introduced in 2011, aims to achieve. The FSMA focuses on stopping contamination and illnesses before they occur, covering various stages of the food supply chain,
... Read more