Month: May 2024

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

Q: But what does “non-compliance” even mean? 

Answer: It could be a lot of things:

• Mislead info: Your product descriptions need to be more accurate or include important details required by regulations body.
• Wrong or Restricted Category: You’re selling something in a category Amazon restricts, even if it’s okay by Health Canada.
• Missing paperwork or certifications: You may need a special license for your product (Foods, Cosmetics, NHPs, & Pet Products), but you don’t have it.

Q: What essential regulations do I need to know for selling on Amazon Canada? 

Answer: Regulations primarily depend on your product. Here’s a breakdown:

• Foods: Ensure compliance with the Food and Drugs Act and the Safe Food for Canadians Act & Regulations. Depending on your business activities, you may need an SFCA License, a Preventive Control Plan (PCP), and potentially specific product approvals.
• Cosmetics: Adhere to the Cosmetic Regulations under the Food and Drugs Act. Health Canada may classify some cosmetics as Natural Health Products or Drugs, requiring additional approvals.
• Natural Health Products (NHPs):  Obtain a Natural Product Number (NPN) and a Site License from Health Canada.
• Pet Products: Veterinary Health Products (VHPs) require a Notification Number from Health Canada. Pet foods must comply with regulations set by the Canadian Food Inspection Agency (CFIA).

For a broader understanding of Amazon seller compliance, check out our blog on The Importance of Amazon Seller Compliance: How to Avoid Penalties.

Q: What is Amazon Canada’s specific labeling and listing requirements?

Answer: Alongside standard Canadian labeling laws for your product, Amazon requires:

• High-quality product images: Represent your product accurately from multiple angles.
• Optimized product descriptions: Include relevant search keywords.
• Bilingual labeling (English/French): Mandatory for most items.

Q: My product’s approved elsewhere. Can I instantly sell it on Amazon Canada?

Answer: Not always. Canada has its own regulations, and Amazon’s internal product classification may sometimes differ from official government definitions.  Thoroughly research compliance requirements for your specific product category. If there’s any ambiguity, consult Health Canada or just simply contact us.

Q: Where do I get regulatory approvals for Amazon Canada?

Answer: To successfully navigate these regulations, it’s helpful to explore the detailed information provided on government websites like Health Canada and the CFIA. If you’d like additional guidance or need help resolving conflicts with Amazon’s product classifications, we can offer personalized support and ensure your products meet the necessary standards.

Q: Does Amazon have restrictions on certain product types?

Answer: Yes. Always check Amazon Seller Central’s Restricted Products list for the latest updates. Be aware that Amazon’s classifications may occasionally differ from Health Canada’s.

Q: I need help navigating this! Can Amazon or anyone else support me?

Answer: Absolutely! Amazon Seller Central offers help pages and support options. However, clarify any discrepancies between Amazon’s requirements and Canadian regulations with Health Canada or a regulatory expert.

We provide tailored consulting for Amazon Canada compliance. Let us create a personalized success plan to help you navigate these regulations – fill up the form below to book your free consultation today!

FDA (U.S) has recently revised its regulatory framework for laboratory-developed tests (LDTs). These in vitro diagnostic products (IVDs) are critical for analyzing substances such as proteins and DNA from human specimens like blood and tissue, playing a crucial role in diagnosing & monitoring health.

 

Why this Matters

LDTs are fundamental in facilitating healthcare decisions, including newborn screening, cancer risk assessment, and the diagnosis of conditions such as heart disease and Alzheimer’s. However, the expanded use of LDTs has raised concerns about their reliability and safety.

Why the Regulatory Shift?

Originally simple and small-scale, LDTs have evolved into complex, high-volume diagnostics integral to major healthcare decisions nationwide. The FDA’s goal is to enhance these tests’ safety, accuracy, and reliability, especially in documented cases where LDTs were misleading or harmful.

What’s Changing?

• LDTs as Medical Devices: The FDA now specifically categorizes LDTs as medical devices under the Federal Food, Drug, & Cosmetic Act (FD&C Act).
• Phasing Out Leniency: Over the next four years, the FDA will gradually eliminate its previously lenient stance on regulating most LDTs.
• Targeted Exceptions: Some LDTs will continue to receive enforcement discretion, particularly those meeting critical needs within integrated healthcare systems.

Key Aspects of the New Enforcement Policies

FDA Classifies LDTs as Medical Devices	Laboratory-developed tests are now explicitly under FDA regulatory authority.
Phasing Out Enforcement Discretion	The FDA will gradually end its lenient approach to regulating LDTs over four years.
Targeted Exceptions	Certain LDT categories may still qualify for relaxed oversight (e.g., tests fulfilling unmet needs within integrated healthcare systems).
Reason for Change	LDTs have become more complex, high-stakes, and widespread, necessitating greater oversight to ensure safety and accuracy.
Impact on Stakeholders	Manufacturers, labs, distributors, retailers, brokers, and healthcare providers must understand and adapt to the new rules.
Benefits of Regulation	Increased oversight aims to boost confidence in LDT results, protect patients, and potentially foster innovation.

What the FDA’s Actions Mean for Healthcare Professionals

With the new regulations, the FDA aims to bolster the safety and effectiveness of LDTs, enhancing confidence among healthcare providers and patients. The gradual implementation is designed to minimize disruption in patient care and allow laboratories time to adapt.

Impact on Businesses

Laboratories and Manufacturers: Directly affected, these entities must assess their LDT portfolios for FDA compliance, adapt quality systems, and prepare for premarket reviews.

Distributors, Retailers, and E-commerce: Must ensure that their LDT sources comply with new regulations, update labeling, and stay alert for FDA advisories.

Strategies for Successful LDT Regulation Compliance

Preparing for the transition to new LDT regulations involves several key steps. Begin by assessing which tests in your portfolio require compliance under the new rules. Consult with regulatory experts or legal advisors to develop effective compliance strategies aligning with your needs. Finally, stay informed about any further updates or guidance from the FDA and industry sources to ensure a smooth and successful transition.

The Future of LDTs

While the regulatory changes pose challenges, they also reflect a commitment to quality within the LDT sector. Improved oversight is likely to foster greater trust in diagnostic outcomes, benefit patients, and spur innovation.

If you have questions about FDA regulations on LDTs or need assistance with compliance and strategic business growth, fill out the form below to book a free consultation with our regulatory experts.