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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If Health Canada determines that a medical device authorized for sale in Canada does not meet safety and effectiveness requirements, manufacturers of a Class I device, and the medical device licence holders of Class II to IV medical devices are requested to prepare and submit an issue-related analysis. Device complaints and incident reports, clinical data and other evidence, exposure data or sales data, device malfunction trends, quality issues, labelling and conclusion must be included in the assessment reports. The default timeframe for submitting an analysis is 30 calendar days from the date of the request unless specified otherwise by the Minister.

If you need any help drafting these reports, contact us and we’ll happily assist you.

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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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As this bill is now in the final stages of the legislative process and is expected to become law this spring, in advance of the upcoming provincial election, it will be important for companies to be prepared for changes needed to comply with the proposed changes.

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

The post Amendment to the Quebec Charter of the French Language appeared first on Focal Point.

• Register your 2020 tonnage with RPRA (Deadline to Register – October 1st)
• Pay your 2021 registry Fee when submitting your 2020 supply data
• Join a Producer Responsibility Organization (PROs)

If you would like further information on this, please do not hesitate to contact us

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Some highlights of implications for exceptional importation and sale of drugs, medical devices, and foods for a special dietary purpose under IO No. 2 include, but is not limited to:

• Any importer who is permitted for exceptional importation and sale under IO No. 2 must notify the Minister electronically, in a format that is specified by, or acceptable to, the Minister, at least five business days before importation. These products will still be subject to some of the requirements set out in the Food and Drugs Act and its Regulations, including reporting adverse drug reactions, recall requirements and mandatory problem reporting (medical devices).
• IO No. 2 modifies the definition of a ‘biocide’ that was defined in IO No. 1 so that the term refers only to disinfectants, and not hand sanitizers, which are regulated differently. Many biocides eligible for exceptional import and sale previously will continue to be permitted under the IO No. 2.
• Under IO No. 2, companies wishing to conduct regulated activities related to drug-based hand sanitizers must obtain and have a DEL. Companies who previously conducted such activities without a DEL and who wish to continue conducting licensable activities related to drug-based hand sanitizers will have six months to apply for a DEL. After applying, companies can continue those activities until a determination is made with respect to their applications.
• IO No. 2 no longer permits companies to provide Health Canada with label text in place of a label mock-up as part of an application for a drug identification number (DIN) or a new drug submission on behalf of a drug-based hand sanitizer.
• Under IO No. 2, products that arrive in Canada through exceptional import must have information on the safe conditions of use available in both English and French. Importers wishing to keep their products in the Canadian market will have six months to come into compliance.

For full details on IO No. 2, please refer to the Health Canada webpage. If you have any questions or would like further clarification on how this may impact your company or products, please contact us.

The post Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2) appeared first on Focal Point.

The impact was first seen in China due to the lockdown in Wuhan, preventing citizens from leaving their homes. A large part of the cosmetic market is in China, but due to the lockdown, sales of cosmetic products have declined. Also, as many cosmetic companies rely on Chinese suppliers for their cosmetic materials, a delay or decrease in production has been seen by many. Finally, the medical device industry has seen a decrease in revenue due to fewer non-emergent procedures in China. This drop in elected procedures has caused lower than expect revenues for medical device companies in China.

Most recently, there have been many cancellations of public events, such as conferences and tradeshows, to prevent further spreading of coronavirus. This has involved the first cancellation of the Healthcare Information and Management Systems Society in 58 years, which was to take place in Orlando, Florida. This event was expected to have many health care professionals in attendance, and therefore the risk was too extreme to rightfully have the event. Another cancelled event was South by Southwest, a music, film and technology festival which was to take place in Austin, Texas and has been known for featuring the latest medical devices. Both events are currently exploring the possibility of hosting a virtual event to make it up to the disappointed attendees.

Other events have been more hopeful and have postponed to a later date. For example, in-cosmetics Global, an event for personal care ingredients, was to take place in Barcelona, Spain at the end of March, but has now been postponed to the end of June. However, there has been no prediction or expectation for the coronavirus to subside. Therefore, it is difficult to say if postponing, cancelling, or taking an event virtual is the best way to handle this unforeseen circumstance. One thing we can be sure about, this impact on the cosmetic and medical device industries will continue until coronavirus becomes less prominent.

For more information on the cancellation/postponement of the mentioned events, please visit South by Southwest, in-cosmetics Global, and Healthcare Information and Management Systems Society. For the most recent information on COVID-19 please visit the WHO.

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

Emily Campbell

The post COVID-19 Impact on Cosmetic and Medical Device Industry appeared first on Focal Point.

Once knowledge of coronavirus becomes available, innovators will need to be ready to invent various creations in the health industry to aid in gaining control of novel coronavirus. Those in the medical device community can help by creating diagnostic technologies. The technologies would be most effective if they could be used quickly- similar to a swab test. The technology would be even more beneficial if the common person were able to use it, resulting in mass diagnosis. Although innovative medical devices would be useful, those diagnosed would still need treatment. Thus far in the treatment of novel coronavirus, care givers have only been able to treat the symptoms of the virus and not the virus itself. Despite researchers’ and pharmaceutical developers’ best efforts, there has yet to be a vaccine for novel coronavirus.

This ultimately leads to the question, how long? How long until medical device technologies and a treatment for coronavirus are available to the public? A troublesome question, with an even more troublesome answer. Even if research on the novel coronavirus became extensive enough to create medical devices or vaccines, these creations would still

have to undergo routine analysis and testing. Those of us in the medical device, pharmaceutical, and regulatory fields know that the process can be long and frustrating at times. The WHO has attempted to accelerate the process through releasing guidelines on subjects including rapid data sharing, research during infectious disease outbreaks, and emergency use of unproven treatments. As well, evaluators in the regulatory field have protocols in place to aid in accelerating the analysis, testing, and trial period of vaccines and technologies for disease outbreaks. Despite this, it is doubtful a vaccine will be available for several months. For now, all we can do is hope researchers and innovators are working together to share knowledge about the virus and can create solutions to this growing global health problem.

Please click on the links to see more information regarding the novel coronavirus from CBC News, the WHO, the CDC, and the Harvard Business Review. To see all the guidelines provided by the WHO for managing infectious disease outbreaks ethically click here.

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

Emily Campbell

The post The Need for Pharmaceutical and Medical Device Advancements in the Race Against Coronavirus appeared first on Focal Point.

So, how does it work? The laser ultrasound machine consists of two lasers; one that emits a light wave and one which receives a soundwave. The conversion from light to sound waves occurs on the skin. The light wave causes the blood vessels in the skin to expand. The body then cools the blood vessels causing them to shrink. This rapidly repeats as continuous light wave approach. The repetition of this process results in vibrations along the skin. These vibrations make up a soundwave. The conversion from light to soundwave was critical for this cutting-edge medical device as soundwaves travel deeper into the body allowing for a more in-depth image of the desired area.

After the conversion, the soundwave travels into the body and is reflected at varying frequencies as skin, muscle, and bone tissue absorb different amounts of the produced soundwave. The reflected soundwave is then absorbed by the second laser. Finally, the information received by the second laser is translated into an image. This medical device is profound by converting the light wave to a soundwave in order to remain independent from the body.

Although ultrasound is already considered a non-invasive procedure, the ability to conduct one without any contact at all is beneficial to patients who cannot be touched. Such patients could be infants, burn victims, and patients trapped in an accident. The researchers at MIT hope to improve the depth and accuracy of this new medical device. The researchers also hope to decrease the size of the technology with the aspiration of making the laser ultrasound a household medical device for preventative and proactive medical care. With technology like this already being discovered this early in 2020, it is clear that the future is bright, inventive, and upon us now!

To see an explanation of the laser ultrasound directly from MIT, please click here. For another article on this topic, please click here.

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

Emily Campbell

The post The Future is Now: A Zero Contact Ultrasound appeared first on Focal Point.

Health Canada has stated that the Medical Devices Directorate will take a life cycle approach to regulating medical devices. In particular, it will “bring together specific post-market functions now led by the Marketed Health Products Directorate, with the pre-market functions of the Therapeutic Products Directorate.” The intent of this approach is to create an organization that uses modernised processes to be able to respond to rapid innovation cycles, increases scientific and policy capacity across the medical device life cycle, and better aligns Canada with our international counterparts. Health Canada has also stated that the Directorate will “allow for a much greater emphasis to be placed on expanding Quality Management Systems to include both internal and external components, and the implementation of ISO 9001, as well as enable better postmarket surveillance capacity for devices”.

The Canadian federal government has implemented several other policy initiatives, including the Regulatory Review of Drugs and Devices (R2D2), the Medical Devices Action Plan (MDAP), and the Treasury Board’s Regulatory Review (RR), that all aim to increase focus on medical devices and, more specifically, the management of medical devices across their life cycles. Combined, these initiatives, along with the Medical Devices Directorate will create a system that is dedicated to the regulation of medical devices and to “improving the safety, oversight and quality” of the medical device landscape, according to a Regulatory Focus article on the issue.

More information from Health Canada on the Medical Devices Directorate can be found here.

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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