Month: April 2025

Name: Health Canada and FDA Regulatory Compliance Solutions
Brand: Quality Smart Solutions
Rating: 4.8 (44 reviews)

Health Canada News

April 2025 Updates to Medical Device Shortage Reporting

Post author By Andrew Parshad
Post date April 29, 2025

How to stay compliant with April 2025 medical device shortage updates

Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed. On April 17, 2025, Health Canada updated the List of Medical Devices – Notification of Shortages, adding new devices that now require mandatory reporting.

If your business handles medical devices, understanding these updates is critical for maintaining compliance. Keep reading to learn more about the new requirements and how you can stay ahead.

What changed in April 2025?

Health Canada has added control syringes with Luer lock tips to the list of medical devices that require mandatory shortage and discontinuation reporting. This update strengthens Health Canada’s efforts to prevent critical device shortages that could impact patient care.

The list of medical devices for shortage notification is incorporated by reference (IBR) into the Medical Devices Regulations. This means any updates to the list are automatically enforceable without further regulatory amendments.

Who must report shortages?

Manufacturers of Class I to IV medical devices and importers of Class I devices must report shortages or discontinuations if their device is listed. Even components, accessories, or parts related to a medical device must be included in shortage reporting when applicable.

Under sections 62.23 to 62.25 of the Medical Devices Regulations, failure to report a shortage could result in compliance actions. If you are a manufacturer or importer, it is your responsibility to monitor the list and submit reports when needed.

You can find more information on the Health Canada medical device shortages web page.

What about voluntary shortage reporting?

In addition to mandatory reports, Health Canada encourages voluntary reporting for medical devices not listed but still facing potential shortages. You are encouraged to report shortages if:

The shortage could create a safety issue for patients or users in Canada
A substitute device, part, or component is not readily available
The shortage is national in scope

To submit a report, you can complete the electronic shortages reporting form or the discontinuation form if applicable.

Tips to stay compliant with medical device shortage reporting

To meet Health Canada’s reporting requirements, it is important to:

Regularly monitor the List of Medical Devices – Notification of Shortages
Prepare internal procedures to identify potential shortages early
Train regulatory and quality teams on how to complete shortage and discontinuation reports
Keep detailed documentation of your shortage assessments

Taking proactive steps ensures you avoid potential penalties and helps maintain trust with your clients and partners.

How regulatory compliance experts can support you

Navigating medical device requirements can feel overwhelming, especially with frequent updates. Our team at Quality Smart Solutions is here to help you stay compliant.

We offer a full range of regulatory support services for medical device companies, including compliance guidance, documentation support, and regulatory consulting tailored to your business needs.

If you need assistance with your medical device regulatory obligations, contact us today to schedule a free consultation with one of our experts. We’re ready to help you protect your business and patients.

For further guidance, you can also consult Health Canada’s Guide to reporting medical device shortages and discontinuations (GUI-0137).

Tags Health Canada, medical devices, Regulatory Updates

FDA News

Why The FDA Is Phasing Out Petroleum-based Synthetic Dyes

Post author By Quality Smart Solutions
Post date April 27, 2025

The FDA’s decision to phase out petroleum-based synthetic dyes is poised to bring major change to food manufacturers across the United States. Announced on April 22, 2025, this update affects a broad range of products and signals a shift toward cleaner, safer food ingredients.

As a food business, it is essential for you to understand what this means and how to stay compliant during this transition. Navigating regulatory changes can feel overwhelming, especially when ingredients that have been used for decades are suddenly restricted.

To help you stay ahead, we’ll walk you through the FDA’s new directive and why it matters for your products. Additionally, you’ll know what actions you should consider taking to ensure compliance and maintain consumer trust. Keep reading to learn more.

What’s driving the shift away petroleum-based synthetic dyes

Petroleum-based synthetic dyes have long been used to enhance the appearance of processed foods, but concerns about their safety have been mounting. Recent scientific reviews suggest potential links between synthetic dyes and adverse behavioral effects, particularly in children.

With mounting evidence and growing consumer demand for safer food ingredients, the FDA has decided it is time for a change.

According to the official announcement, this move is part of a broader initiative to reduce exposure to synthetic additives and improve the overall health of the public. You can read the full FDA statement here.

What this means for food manufacturers

If your product formulations include petroleum-based synthetic dyes, you will be required to reformulate using natural or approved alternatives. This may affect product color, shelf life, and consumer perception. Transitioning to compliant alternatives early will help you avoid disruptions once the phase-out is fully enforced.

The FDA has promised to work closely with industry stakeholders to ensure a smooth transition. However, companies that delay adjustments could face enforcement actions or disruptions to their supply chains.

Key steps to take now regarding petroleum-based synthetic dyes

The synthetic dyes phase-out marks a significant change for the food industry. Nonetheless, it also opens the door to align more closely with growing consumer demand for clean, safe ingredients.

Therefore, taking early action can protect your business while also enhancing brand trust and loyalty. Here are some key steps to help you get started:

Audit your ingredient lists: Identify all products containing synthetic dyes targeted by the FDA.
Research natural alternatives: Natural colorants like beet juice, turmeric, or spirulina may offer suitable replacements.
Plan for reformulation: Work with your regulatory team and suppliers to adjust recipes while maintaining quality.
Update labels: Changes in ingredients may require updates to your product labels to stay compliant with FDA labeling requirements.
Stay informed: Keep track of FDA updates and consult experts to ensure your transition plan aligns with evolving regulations.
Get regulatory support: Engaging a regulatory consulting partner, like Quality Smart Solutions, can provide valuable guidance throughout the transition and help ensure nothing falls through the cracks.

How Quality Smart Solutions can support your compliance needs

As you can see, transitioning away from petroleum-based dyes involves more than swapping ingredients. It requires a strategic approach to product reformulation, regulatory submissions, and label updates. That’s why our experts can assist you in navigating these complex changes with services such as:

Ingredient compliance audits
Regulatory review and consulting
Label compliance and updates
Ongoing regulatory monitoring and support

Acting early not only helps you maintain compliance but also strengthens your brand’s reputation in a market that increasingly values transparency and natural ingredients.

Stay ahead of regulatory changes by partnering with experts who understand the evolving landscape. Reach out to our team today to ensure your compliance journey is smooth and successful.

Tags FDA regulations, food additives, food compliance, ingredient compliance

Blog Regulatory Compliance

How to Prepare a Food Additive Submission for Health Canada

Post author By Andrew Parshad
Post date April 25, 2025

Food additive submission may not be the flashiest part of launching a new food product in Canada, but it’s one of the most essential. If your ingredient isn’t listed under Health Canada’s approved food additives, you’ll need to submit it for evaluation before it can legally be used.

Wondering what it really takes to get your food additive approved? Whether you’re introducing a new substance or updating how an existing one is used, the process can be detailed and technical.

Keep reading to discover how to prepare a food additive submission that checks all the right boxes. We’ll walk you through what needs to be included, how to present it effectively, and how to avoid the most common pitfalls that lead to delays.

What is considered a food additive under Canadian law?

According to Health Canada, a food additive is any substance that becomes part of a food or alters its characteristics, directly or indirectly. This includes preservatives, colouring agents, and emulsifiers, but excludes nutrients like vitamins or minerals unless used in novel ways.

Importantly, only additives included in the Lists of Permitted Food Additives are legal for use in Canada. If your ingredient or its intended use isn’t on that list, a submission to Health Canada is mandatory.

When is a food additive submission required?

A food additive submission is required when:

The additive isn’t currently approved in Canada.
The proposed use differs from the existing permitted use (e.g., new food category or higher levels).
You’re introducing a new functional purpose for an approved additive.

Health Canada uses this process to evaluate the safety, potential exposure, and benefits of the proposed additive. Without approval, using the additive could lead to compliance issues, import detentions, or even product recalls.

Preparing your submission: key components

To prepare a compliant submission, you’ll need to gather the following information:

Identity and composition: Provide detailed information about the chemical makeup and purity of the additive.
Function and benefits: Describe the technical purpose of the additive, such as preservation or thickening.
Safety data: Include toxicological studies, allergenicity profiles, and any safety evaluations from other jurisdictions (like the FDA or EFSA).
Exposure analysis: Estimate how much of the additive consumers are likely to ingest across different age groups and consumption patterns.
Specifications and methods: Detail the manufacturing process and analytical methods used to ensure consistency and quality.

For guidance on developing these documents, Health Canada outlines detailed requirements in their Guidelines for Food Additive Submissions, which provide a clear framework for assembling your technical dossier.

Common mistakes and how to avoid them

Incomplete or vague data is a leading cause of submission delays. Companies often submit documentation without clear scientific rationale or miss key elements like exposure data. Here are three common pitfalls and how to sidestep them:

Missing safety data: Be proactive. Compile toxicological and dietary exposure studies upfront.
Unclear technical justification: Clarify exactly why the additive is needed and how it improves product quality or safety.
Poor formatting: Follow the structure and formatting outlined in Health Canada’s guidance to reduce review times.

How long does approval take?

Timelines vary, but Health Canada generally completes evaluations within 12 to 18 months, depending on the complexity of the additive and the completeness of the submission. Complex submissions with international precedent may move faster, especially when supported by robust data from regulators like the FDA.

Why expert guidance makes a difference

Regulatory submissions are both a science and a strategy. For food innovators, startups, and global brands entering the Canadian market, partnering with an experienced regulatory team can speed up approval and reduce stress.

At Quality Smart Solutions, we help you identify gaps early, assemble the right data, and communicate clearly with Health Canada. Our end-to-end support ensures your submission meets all regulatory expectations and avoids unnecessary revisions.

Ready to move forward with your food additive submission?

If you’re planning a food additive submission and want to get it right the first time, we’re here to help. Our experts will guide you through every step, from dossier preparation to final approval.

Our GRAS Experts division provides tailored support for food additive submissions in Canada. From dossier preparation to regulatory strategy, we guide you every step of the way. You can learn more about these services on our Health Canada Food Additive Submission page.

Contact us today or fill out the form below to schedule a free consultation. Let’s bring your product to market with confidence and compliance.

Tags food additives, food compliance, food industry, Health Canada

Blog Cosmetics

How to Avoid Amazon Canada Cosmetic Delisting

Post author By Andrew Parshad
Post date April 22, 2025

Selling cosmetics on Amazon Canada can open up a world of opportunity, but it comes with strict compliance expectations. Recently, many sellers have faced Amazon Canada cosmetic delisting due to missing or incomplete regulatory documentation. This issue not only disrupts sales but can damage your brand’s reputation and standing with Amazon.

To prevent these setbacks, you need to align your product listings with Health Canada’s cosmetic regulations and Amazon’s documentation requirements. Keep reading to learn how to stay compliant, keep your listings live, and avoid unnecessary delistings.

Understand Health Canada cosmetic requirements

Before listing any cosmetic product in Canada, it’s critical to determine whether it meets the definition of a cosmetic under the Food and Drugs Act. Health Canada defines cosmetics as products applied to the body to clean, improve, or alter appearance, such as lotions, shampoos, makeup, and deodorants.

Each cosmetic product must be supported by:

A Cosmetic Notification Form (CNF) submitted to Health Canada within 10 days of first sale.
A complete ingredient list using INCI names, placed on the label.
Bilingual labelling that includes the product identity and net quantity.

Failing to meet any of these criteria can make your listing non-compliant, prompting Amazon to delist it.

You can review the official Health Canada cosmetic regulations for more guidance on ingredient safety, product classification, and compliance expectations.

What triggers delisting on Amazon?

Amazon requires proof that your cosmetic product is safe and authorized for sale in Canada. If Amazon’s compliance team requests documentation and you fail to provide it, your product may be suspended or removed. Common reasons for delisting include:

Missing Cosmetic Notification Number (CNF confirmation)
Incomplete or unverified ingredient list
Labels that don’t meet bilingual or INCI requirements
Products flagged as drugs or NHPs rather than cosmetics

In some cases, sellers are unaware that their product is classified differently. Amazon may use AI or keyword-based detection to flag certain ingredients or claims, so even your marketing language can trigger a compliance review.

What you can do to prevent delisting

To avoid Amazon Canada cosmetic delisting, ensure that your product is registered and your documentation is organized before you list. Here are key steps to protect your listings:

1. Submit your Cosmetic Notification Form (CNF)

You must submit a CNF to Health Canada and receive an acknowledgment email. Save this confirmation, as Amazon may ask for it at any time. For full details, refer to Health Canada’s official Guide to Notification of Cosmetics.

2. Ensure your label meets Health Canada requirements

Make sure your label includes the INCI ingredient list, bilingual product name, and proper formatting. You can review Health Canada’s official Labelling of Cosmetics Guide to ensure your product meets all requirements. Avoid health claims that could reclassify your product as a drug or NHP.

3. Respond quickly to Amazon’s compliance requests

If Amazon contacts you requesting documentation, act fast. Delays in responding can result in your listing being pulled. Prepare a compliance folder with your CNF, ingredient list, and label in advance.

4. Get support from a regulatory expert

If you’re unsure whether your product meets cosmetic classification or label rules, working with a compliance partner can help. At Quality Smart Solutions, we guide businesses through Health Canada cosmetic notification, bilingual labelling, and Amazon compliance submissions.

Stay compliant and keep your products listed

You work hard to build your brand. Don’t let a preventable mistake interrupt your sales. By proactively meeting Health Canada’s cosmetic requirements and being ready to respond to Amazon’s requests, you can protect your listings and grow with confidence.

Need help with your CNF submission or cosmetic classification? Visit our Amazon Canada Compliance page or explore our Cosmetics services page for more information. You can also contact us or fill out the form below to book a free consultation with one of our regulatory experts.

Tags Amazon compliance, Cosmetics, Health Canada, product delisting

FDA News

FDA announces ESG NextGen launch for industry submissions

Post author By Andrew Parshad
Post date April 17, 2025

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.

The launch marks a major infrastructure upgrade. With improved file handling, automated submission tracking, and strengthened cybersecurity, ESG NextGen is designed to reduce submission errors, improve visibility, and support a more efficient regulatory process.

Keep reading to find out how to register, what’s new, and how you can prepare your team.

What is FDA ESG NextGen?

FDA ESG NextGen is the modernized version of the Electronic Submission Gateway (ESG). Developed under the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act (BsUFA) commitments, the platform was created to resolve performance issues with the older system and support high-volume, complex submissions across industry sectors.

If your company regularly interacts with the FDA through structured electronic submissions, ESG NextGen is now your official point of access.

Benefits of the new ESG NextGen system

Here’s what makes this new platform easier and more efficient for you:

User-friendly portal: The Unified Submission Portal (USP) has replaced WebTrader with a more intuitive design.
Real-time tracking: You can check the status of your submission anytime.
Stronger cybersecurity: With multi-factor authentication and better access control, your data stays protected.
Automated workflows: The API feature allows your systems to connect directly and send updates automatically.
Simplified requirements: You won’t need a signing certificate for USP submissions.

How to register and get started

To start using FDA ESG NextGen, visit the official FDA ESG NextGen registration page to log in or create your account.

During your first submission, you’ll be prompted to download the File Catalyst Transfer Agent. This tool helps speed up your file transfers and ensures secure delivery.

You can also review official training resources before getting started:

Daily drop-in support sessions

If you need help navigating the system, the FDA is offering live support. You can join daily drop-in sessions until April 25, 2025, at 1:00 PM ET via Microsoft Teams. Each session is open to the public but limited to 1,000 attendees, so be sure to join early to secure a spot.

Meeting ID: 299 130 361 466
Passcode: m7Rw6Fz9
Join via the FDA portal

Common questions from businesses

If you’re getting ready to switch to FDA ESG NextGen, you likely have a few questions. Here are some of the most common ones that companies are asking as they transition to the new system:

Will WebTrader still work?

No. WebTrader has been retired as of April 14, 2025.

Do I need new software?

Yes. The system will prompt you to install the File Catalyst Transfer Agent when you begin.

Can I still use AS2?

Yes. AS2 remains supported and still requires a signing certificate.

Is a signing certificate needed for USP?

No. Signing certificates are no longer required for USP submissions.

Make your transition smooth

The launch of FDA ESG NextGen represents a shift in how companies manage regulatory communications with the FDA. Adapting quickly is essential to avoid submission delays and ensure continuity in product registration or compliance filings.

Need help registering or planning your next submission? Contact us today or fill out the form below to get a free consultation with one of our experts. Talk to a Quality Smart Solutions expert today and ensure your FDA compliance process is ready to go.

Tags FDA, Regulatory Compliance

EFSA News Regulatory Updates

EFSA Opens 2025 Call for Novel Food Advice to SMEs

Post author By Andrew Parshad
Post date April 13, 2025

Are you a small or medium-sized business (SME) planning to launch a novel food in the European Union? If so, this is your chance to receive free EFSA novel food advice before submitting your application. The European Food Safety Authority (EFSA) has launched its second call for expressions of interest, specifically targeting SMEs preparing for novel food approvals.

Whether you’re still in early development or putting the final touches on your application, EFSA is offering tailored support to help you get it right from the start. Keep reading to learn how this advisory service can simplify your regulatory path and how to apply before the June 12, 2025 deadline.

What is EFSA’s SME advisory service?

EFSA’s initiative helps SMEs navigate the complex novel food application process in the EU. Through this call, eligible SMEs can access the General Pre-Submission Advice (GPSA) service in one of two formats:

Early advice meetings for those still developing their novel food
Pre-submission meetings for applicants close to finalizing their dossiers

These virtual consultations are designed to address your specific questions about the rules, requirements, and documentation needed to move forward with confidence.

Why apply for EFSA novel food advice?

For many SMEs, navigating EU regulations for novel food approval can be daunting, especially without prior experience. EFSA’s free advisory service offers several advantages:

Clarifies regulatory expectations and content requirements Avoids
common mistakes that delay approvals
Improves submission quality from the outset
Saves time and resources during the intake phase
Boosts your application’s success rate

Last year, 47 SMEs benefitted from this service. Most participants found the sessions highly valuable, particularly those unfamiliar with EFSA procedures.

Who’s eligible?

To qualify for EFSA’s 2025 advisory service, your business must meet the following criteria:

Be an SME under the EU’s definition
Intend to submit a novel food or traditional food application to the European Commission
Have limited or no prior experience submitting novel food applications
Submit questions that fall within the scope of EFSA’s GPSA services

Even if you participated in the 2024 edition, you’re welcome to apply again-as long as your request concerns a different novel food.

Application timeline and process

If you’re planning to take advantage of this opportunity, make sure you stay on top of the timeline. Here are some key dates to remember:

Deadline to apply: June 12, 2025 at 13:00 CEST
Meetings scheduled: April to July 2025 (rolling basis)

To apply, you’ll need to fill out the Expression of Interest form through Microsoft Forms. Your submission should include a description of your novel food, intended market, timeline for submission, and your regulatory questions.

EFSA will review each application as it’s received. If you meet the criteria, they’ll contact you to schedule your advice session.

What to expect in your meeting

In early advice meetings, EFSA will guide you on:

Regulatory scope and EFSA’s role
Key documents and how to use EFSA platforms
Confidentiality protocols and study notification requirements

In pre-submission meetings, you’ll receive insight into:

Common dossier pitfalls
Administrative and scientific expectations
Documentation do’s and don’ts

No informal assessments will be conducted. EFSA provides advice only within the limits of current guidance.

Need help preparing your EOI?

At Quality Smart Solutions, we support SMEs in the food and ingredient sectors with regulatory strategy, document preparation, and application reviews. If you’re considering applying for EFSA novel food advice, our team can guide you through the eligibility requirements and help prepare a compelling submission.

Contact us or fill out the form below to get a free consultation with one of our experts and explore how we can help you with your EU compliance journey.

Tags EFSA, Novel Foods

Events Upcoming

SIAL Toronto 2025

Post author By rkumar@qualitysmartsolutions.com
Post date April 9, 2025

Join Quality Smart Solutions at SIAL Toronto 2025, Canada’s premier event for the food and beverage industry. This international tradeshow brings together top innovators, suppliers, manufacturers, and experts from across the globe to shape what’s next in food.

As regulatory frameworks continue to evolve, our team is here to help you navigate Health Canada, FDA, and international compliance requirements for packaged foods, functional ingredients, and natural health products. Whether you’re launching a new product or entering new markets, we’re ready to support your success.

How We Can Help

Regulatory expertise: stay ahead of evolving food regulations and avoid costly delays.
Ingredient and product compliance: meet Health Canada and FDA standards for packaged and functional foods.
Label & claims review: ensure your product labels and marketing claims align with Canadian and U.S. regulations.
Go-to-market strategy: streamline your approval process and enter new markets with confidence.

Schedule a Meeting

We’ll be available for in-person meetings during the show, from April 29 to May 1 at the Enercare Centre in Toronto, Canada. Don’t miss your chance to connect with our regulatory specialists and discover how we can help you grow your business.

Tags Foods, ingredients, Natural Health Products, Supplements

Blog Health Canada Natural Health Products (NHPs)

What’s the Difference Between Functional Foods and NHPs?

Post author By Andrew Parshad
Post date April 8, 2025

If you’re planning to launch a product like a protein bar, electrolyte drink, or mushroom supplement in Canada, it’s important to understand the difference between functional foods and NHPs (natural health products). If you don’t, you could run into problems like compliance issues, delays, or even product recalls. Figuring out which category your product falls into is one of the first steps toward getting it approved and ready for sale.

This article will break down the essential distinctions between Functional Foods and Natural Health Products. You’ll learn how to spot the differences and avoid costly mistakes. Keep reading to discover how to align your product with Health Canada’s classification framework and stay on track for a smooth market launch.

Understanding the difference

Health Canada separates Functional Foods and Natural Health Products (NHPs) based on composition, intended use, format, and how consumers perceive them. For example, fortified beverages and protein powders might fit either category depending on their ingredients and marketing.

You can refer to Health Canada’s classification guidance for specific criteria. To make this comparison easier, here’s a visual breakdown:

Key considerations for classification

Before entering the market, you need to know how your product will be regulated. Health Canada uses several factors to determine the correct classification. Here’s how to start evaluating whether your product fits better as a Functional Food or a Natural Health Product:

Ingredients: Does your product include medicinal components like high-dose caffeine or isolated vitamins? If so, it’s likely an NHP.
Health claims: Statements like “boosts memory” or “relieves stress” typically require an NPN, placing the product in the NHP category.
Format: Capsules, tablets, or tinctures are usually NHPs. In contrast, snacks, beverages, and bars are generally considered foods – unless other criteria suggest otherwise.

Steps to ensure compliance

Once you’ve identified whether your product leans more toward a Functional Food or a Natural Health Product, it’s time to make sure you’re following the right regulatory path.

The steps below can help reduce compliance risks and prepare you for a smoother market entry.

Assess your product thoroughly: Consider your ingredients, claims, and format to determine classification.
Use Health Canada resources: Review classification guidelines and consult the Natural Health Products Ingredients Database.
Work with regulatory experts: Avoid mistakes and save time by partnering with professionals who understand the classification process.
Review your labels and marketing language: Ensure that product packaging and promotional materials align with your product’s classification to avoid non-compliance issues.
Plan for post-market obligations: If your product qualifies as a Natural Health Product, be prepared to follow GMP requirements, maintain safety records, and submit adverse event reports if necessary.

Get expert support

Classifying your product correctly in Canada can feel overwhelming. But you don’t have to do it alone. At Quality Smart Solutions, we guide companies through every step of compliance. From product classification to label reviews, we help make the process smoother.

We also offer full-service support for natural health products and food compliance in Canada. Whether you’re launching a protein bar, a supplement, or a new beverage, our regulatory experts can help you navigate your next steps.

When your product is classified properly, it earns consumer trust, shortens approval times, and sets your business up for success.

Tags Functional Foods, Health Canada, Natural Health Products

Blog Health Canada Natural Health Products (NHPs)

What Is an NPN and Why It Matters in Canada?

Post author By Andrew Parshad
Post date April 6, 2025

If you plan to sell a natural health product in Canada, you’ve probably asked what an NPN is and why it’s important. A Natural Product Number (NPN) is an eight-digit identifier issued by Health Canada that confirms a product has been assessed and approved for safety, efficacy, and quality. The NPN is product-specific and must appear on the packaging of a product for sale.

Without an NPN, your product cannot be legally sold in Canada. Even if it’s available internationally, you still need Health Canada’s approval to enter the Canadian market. Without it, you risk enforcement actions, limited distribution opportunities, and a lack of trust from both retailers and consumers.

Keep reading to learn how the NPN process works and why it’s essential for compliance and consumer trust. Want a quick visual overview first? Check out our infographic below.

What is an NPN?

An NPN is a licensing number assigned by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). It ensures that your product meets strict quality standards and is safe for public use and consumption.

You’ll find the NPN printed on the product label or carton of every authorized natural health product sold in Canada. In this context, NPNs can appear in products like vitamins, minerals, herbs, and other natural health products.

Why do you need an NPN?

Canada has one of the most regulated markets for natural health products in the world. An NPN shows that your product has gone through a proper and extensive review process for safety and efficacy. This helps protect consumers and builds credibility with retailers and distributors.

Selling without an NPN is highly risky and could have major implications. You could face enforcement actions, product recalls, or penalties. If you want to successfully enter the Canadian market, securing an NPN is a must.

What products require the number?

If your product is marketed with health claims and contains naturally derived ingredients, you probably need an NPN. This includes:

Multivitamins and minerals
Probiotics and enzymes
Herbals
Amino acids and essential fatty acids
Traditional medicines

You can find full details on what qualifies as a natural health product on Health Canada’s official website.

How to get an NPN in Canada

To receive an NPN, you must submit a product licence application to Health Canada. The application may include:

Product formulation
Evidence supporting the safety and efficacy of the product
Proposed health claims and recommended use
Manufacturing and quality control processes
Product label information

Depending on your product’s complexity, the review process can range from 60 days to several months. This makes planning ahead critical for a successful launch.

Need help with your application?

Many companies struggle with delays and rejections because of incomplete applications or missing documentation. Working with a regulatory expert ensures your submission meets all of Health Canada’s requirements and moves through the system faster.

At Quality Smart Solutions, we help businesses navigate every step of the NPN process. Whether you need full application support or advice on specific sections, we’ve got the expertise to guide you through.

Explore our full NPN application services to see how we can support your compliance goals. Ready to move forward? Fill out the form below to book a free consultation with one of our experts, or contact us directly to get in touch.

Tags Health Canada, Natural Health Products, Npn, Regulatory Compliance

Blog Health Canada Medical Devices

What Is MDSAP and Why Does It Matter?

Post author By Quality Smart Solutions
Post date April 3, 2025

If you’re working in the medical device space and looking to expand into the Canadian market, here’s a question for you: do you really understand what MDSAP means for your business?

The Medical Device Single Audit Program plays a central role in how Health Canada evaluates your Class II, III, and IV devices. Understanding how it works can be the difference between getting your product approved or hitting a regulatory roadblock.

Many companies underestimate how in-depth the program really is. That lack of clarity can lead to delays, rejected licences, and lost revenue. It can feel like you’re hitting barrier after barrier just to get your product across the finish line.

If you’re unsure about what’s involved or what your next step should be, you’re in the right place. This guide will walk you through the essentials of MDSAP, explain what Health Canada expects, and give you practical insights to help you stay compliant.

Keep reading to feel more confident, better prepared, and more in control of your regulatory strategy.

What is MDSAP

MDSAP stands for Medical Device Single Audit Program. It allows medical device manufacturers to undergo a single regulatory audit that satisfies the quality management system requirements of multiple countries. These include:

Canada (Health Canada)
United States (FDA)
Australia (TGA)
Brazil (Anvisa)
Japan (PMDA and MHLW)

For Canadian compliance specifically, Health Canada requires all manufacturers of Class II, III, and IV medical devices to provide valid MDSAP certification when applying for or renewing a Medical Device Licence (MDL). This requirement has been in effect since January 1, 2019.

Why Health Canada uses MDSAP

Health Canada adopted MDSAP to strengthen oversight while reducing the need for duplicative audits. The system ensures that your quality management system (QMS) meets ISO 13485 standards and country-specific regulations.

With MDSAP in place, Health Canada can rely on third-party audit reports to make regulatory decisions, which saves time for both regulators and companies. If your audit is successful, you’re cleared for MDL submission. If there are issues, you’ll know what to fix early before you submit your application.

Who needs MDSAP

If you manufacture Class II, III, or IV medical devices and want to sell them in Canada, you need MDSAP certification. This applies to:

Canadian manufacturers
Foreign manufacturers selling into Canada
Companies that already have an MDL and are renewing it

Class I medical device manufacturers are exempt from this requirement but still need to meet other compliance obligations such as holding a valid Medical Device Establishment Licence (MDEL).

Benefits of MDSAP

Aside from being a requirement, MDSAP offers several benefits:

Global efficiency: One audit satisfies multiple regulators
Time savings: Reduces repetitive audits and documentation
Compliance readiness: Identifies nonconformities before regulatory reviews
Market access: Positions your company to expand into other MDSAP-recognizing countries

This is especially useful for businesses planning international growth. A single audit can help you access five major markets without the burden of separate inspections.

Common challenges and how to overcome them

Preparing for an MDSAP audit can feel overwhelming. The most common hurdles include incomplete documentation, inconsistent QMS implementation, and lack of internal training. These issues can result in costly delays.

That’s where expert support makes a difference. Our team at Quality Smart Solutions helps you prepare for MDSAP audits, address gaps in your QMS, and guide you through the documentation process from start to finish.

Get support for your MDSAP journey

Staying compliant doesn’t have to be complicated. Whether you’re applying for your first MDL or preparing for an upcoming renewal, having the right partner can make all the difference.

Ready to move forward? Contact us today or fill out the form below for a free consultation with a regulatory advisor. We’ll help you understand exactly what’s required and how to meet MDSAP expectations with confidence. Not quite ready? No worries! Explore our medical device compliance services to learn how we support companies like yours every step of the way.

Tags Health Canda, medical devices