In addition, as of April 01, 2026, all Class II, III and IV medical device applications and amendments must be submitted electronically through the Regulatory Enrolment Process via the Common Electronic Submissions Gateway. Email submissions will no longer be accepted.

Health Canada has also implemented a new Terms and Conditions framework for device licenses, strengthening post-market oversight and adopted the International Medical Device Regulators Forum Table of Contents format to align with global standards. These changes aim to streamline submissions and improve regulatory efficiency.

If you need additional information or guidance on navigating these new processes, please reach out to us.

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These proposals will be completed in phases, with Phase I involving the improvement of labelling of Natural Health Products, which has been completed as of 5th July, 2022. This amendment will include:

• Product fact tables
• Formatting requirements
• Improving allergen labelling
• Tamper evidence alignment under CUSMA
• Modernized contact information

The following Phase II will introduce expedited pathways for lower-risk non-prescription drug products, with Phase III expanding the efficiencies and modernization pertaining to non-prescription drugs to NHPs.

The period in which new products will phase in the amended regulations is 3 years, with an additional 3 years for existing products. Additional details such as the associated guidance documents accompanying the regulation changes will follow via the NNHPD.

Click here to view the original article published by the Canada Gazette.

If you have any questions on the updates or would like assistance with NHP compliance, please contact us.

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How may this affect your business?

Notable changes brought by Bill 96 include narrowing the recognized trademark exception (that applies to registered and unregistered marks) to only apply to registered trademarks on product packaging. Even if your non-French mark is registered, any generic or descriptive portions included in your registration will have to appear in French elsewhere on the product permanently affixed to it. Other changes include a prohibition on making available commercial publications, invoices, receipts, and other documents in another language unless the French translation is unavailable.

Businesses will have three years to comply, and these requirements come into force on June 1, 2025. Fines will be imposed for non-compliance ranging from $700 to $7000 (for individuals) and $3000 to $30,000 (for companies).

For additional information on this or if you have any questions, please do not hesitate to contact us.

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If you would like further information on this or have any questions on how this may impact your business, please contact us. We are leading regulatory and quality consultants and can answer any questions pertaining to this.

The post Consultation on Upcoming Changes to NHP Labelling Regulations appeared first on Focal Point.

As of the Jun. 25, 2021 effective date, all new Acne products must follow the revised Health Canada monograph labeling requirements and for existing products, these should be in transition to ensure compliance with the new monograph.

For additional information on transitioning your products or questions you may have regarding this update, please do not hesitate to contact us.

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Talc is a naturally occurring mineral that can be found in a number of self-care products, including cosmetics, non-prescription drugs and natural health products (NHPs). The final assessment identified the following:

1. It may cause ovarian cancer when present in products intended for use in the genital area such as wipes, baby powder, diaper and rash creams, bath bombs, and genital antiperspirants or deodorants;
2. It is potentially harmful to your lungs if you breathe in loose powder products such as body, baby and face powders;
3. It does not present any health concerns if used in pressed powder products, dry shampoos, foot powders, products that come into contact with skin excluding the genital area and non-prescription products or NHPs intended to be ingested;
4. It is not harmful to the environment.

Talc is currently listed on the Cosmetic Ingredient Hotlist and is restricted in cosmetic products intended to be used on children. Given the results of the risk assessment, Health Canada is proposing further action to lower talc exposure from products that could be inhaled or used in products intended for the genital area. The proposed actions include:

• Adding talc to the Toxic Substances List in Schedule 1 of the CEPA – this would not restrict its use, manufacture or import, but rather enable the Government to take risk management actions under CEPA
• Changing existing entries on the Cosmetic Ingredient Hotlist and NHP Ingredient Database to include measures to reduce exposure to talc from products which may be inhaled or result in perineal exposure

Industry and other interested stakeholders are invited to participate in an electronic consultation on the proposed Risk Management Approach until Jun. 23, 2021.

If you have any questions or concerns or would like further clarification on the implications of the risk assessment and risk management approach, please feel free to contact us.

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According to Medical Design & Outsourcing, the FDA has warned the public of a potential medical device shortage as a result of the plant shutdown. Roughly 90% of the products sterilized at the Sterigenics Willowbrook facility were medical devices and manufacturers of those products will be greatly impacted by this plant shutdown.

Health Canada has issued a clarification notice on what sort of changes to sterilization procedures would require Medical Device Licence (MDL) amendments. According to Emergo, Health Canada has advised that facility changes alone do not warrant a new MDL application submission. However, MDL amendments are required for changes to sterilization procedures, equipment or cycle parameters. MDL amendments are also required for the following:

• Changes that increase bioburden alerts or action levels;
• Changes that introduce organisms more resistant to sterilization effects;
• Device design and material changes that introduce features more difficult to sterilize;
• Changes in density or configuration of a sterilization load;
• Changes to quality control verification and validation processes.

As a result, moving the sterilization facility may result in one or more of the above changes, therefore leading to potential MDL amendments for several medical devices.

If you require assistance complying with medical device regulatory requirements or would like more information on the matter, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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According to Cosmetics Design USA, vice president of global digital services at Amway, Mike Edwards, states: “If you look at companies like Uber, they didn’t do anything unique. It’s still the taxi industry. But they leveraged digital tools to make that a very compelling opportunity. It’s the same thing if you look at direct selling and you look at Amway. If we don’t disrupt the industry by leveraging digital tools, we’ll become irrelevant.”

The overarching purpose of the app developments is to help Amway Business Owners (ABO) serve their customers better and drive mobile sales, while strengthening the relationship between the ABO and customer through digital technology. By storing components of the app on a global cloud storage space, standardization becomes easier to achieve between apps, and allows for brand consistency among markets in different countries.

Brian Hart, vice president of ABI customer solutions and IT at Amway, declares that the app development plan will save a substantial amount of money while allowing the company to gain international brand awareness and further improve customer experience. “Everyone has a mobile phone, but not everyone has a computer,” observes Hart. By leveraging this common device, Amway reduces the possibility of an external competitor disrupting their business with app development solutions in the future.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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Health Canada published an updated timeline for the various phases in the framework’s implementation process.  Due to the upcoming Canadian Federal Election, there have been changes to the original schedule. After public consultations, the updated approach to regulating self-care products is targeted to be phased in over the next few years:

Phase I (Spring 2020) – Health Canada will introduce labelling amendments to Natural Health Products (NHPs). The changes will include improving the facts table for easier comparison between similar self-care products, as well as plain language on labels for consumers to easily understand.

Phase II (Spring 2020) – Health Canada will introduce a risk-based approach to regulating non-prescription drugs under the Food and Drug Regulations (FDR). The approach will include expedited pathways for lower-risk products such as sunscreens and acne products to align with regulations for self-care products with similar risk level.

Phase III (2021) – Health Canada will introduce regulatory amendments to address health claim evidence standards and extend regulatory oversight with a risk-based approach. Phase III will also seek additional controls for Health Canada such as having the ability to require recall or label change for all self-care products.

These changes to the regulatory framework are anticipated to support the safe and intended use of self-care products to help Canadians make more informed decisions when buying products. It is also intended to establish proportional regulatory rules based on risk, which would result in significant cost reduction for health care businesses..

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading Canadian regulatory and Health Canada consultants for Natural Health Products, OTC Drugs, Cosmetics, and other personal care products.

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The Canadian Environmental Protection Act, 1999 (CEPA, 1999) was implemented by Health Canada to protect the environment and human health by contributing towards sustainable development. A section of the Act focuses on decreasing the risks associated with new and existing substances. Substance lists were established to distinguish new substances from existing ones, and to determine reporting requirements or risk assessments needed for certain substances.

The In-Commerce List is an administrative list created for substances regulated under the Food and Drugs Act (FDA) that had been subject to the New Substances Notification Regulations (NSNR) and CEPA 1999 in September 2001. The Revised In-Commerce List (R-ICL) was created to address necessary concerns of substance duplications, omissions, and inaccuracies that were on the In-Commerce List.

Recent News Updates:

One year following a final notice published in the Canada Gazette Part I in November 2018, nomination of substances to the Revised In-Commerce List will close on November 3^rd, 2019. Of the substances that are regulated under the Food and Drugs Act, substances that are no longer in commerce will likely be removed from the R-ICL in future updates.

The following 20 pharmaceutical ingredients were under review in 2017-2018 as higher priority substances with potential risk to human health: Alendronate sodium and Alendronic acid; Modafinil; Divalproex sodium; Gliclazide; Gabapentin; Lamotrigine; Sucralfate; Celecoxib; Ephedrine, Ephedrine dl-, and Ephedrine sulfate; Entacapone; Atomoxetine hydrochloride; Atovaquinone; Bupropion hydrochloride; Cefazolin sodium; Oxcarbazepine; Acebutolol hydrochloride; Domperidone, Domperidone maleate; Lopinavir; Telmisartan; Olanzapine.

The assessment reports for these 20 ingredients are scheduled to be published in 2020/2021. Post 2020, HC aims to retire the R-ICL list by publishing rapid screening documents for low-priority/low volume substances and bringing feasible substances into compliance with CEPA regulations to be incorporated into the Domestic Substances List (DSL). Non-response to Section 71 substances will result in removal from the R-ICL.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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