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.

The post Health Canada modernizes Medical Device Submission Requirements appeared first on Focal Point.

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.

The post Summary Reports and Issue-related Analysis Reports appeared first on Focal Point.

The preliminary report should be submitted to Health Canada within 10 calendar days of the occurrence of the incident if it has occurred in Canada and as soon as possible for any foreign incident. It should outline the reportable incident which has taken place, and complete details pertaining to the investigative process initiated by the reporter to determine the root cause. A timetable mentioning the proposed dates for implementing the action plan and final report submission must be included. The final report must then be submitted after the design and implementation of corrective and preventive actions is finalized including an analysis of the results and conclusions of the investigation. The reports should be highly detailed consisting of the specifics relating to the incident, medical device that caused it, the source of the reported event.

If you need further information or require help in generating incident reports, please contact us.

The post Medical Device Incident reporting appeared first on Focal Point.

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.

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.

The post Health Canada Announces the Creation of a New Medical Devices Directorate appeared first on Focal Point.

Victor Gura, MD, an internist and nephrologist from Los Angeles, has invented a portable dialysis device that is designed to improve the overall quality of life of dialysis patients. In place of a 300-pound dialysis device, the WAK is worn on a belt and provides the benefits of daily dialysis without compromising normal routines.

How does it work?

The WAK is battery operated, which is a unique alternative to the current machines that require constant access to an electrical outlet. It features a unique concept that regularly eliminates fluid to reduce kidney strain, while also controlling blood pressure. The invention has developed from weighing 11 lbs to only 2 lbs and is connected to the patient using a single catheter, inserted under local anesthetic. This allows the patient to perform a multitude of activities while having dialysis, which would not have been remotely possible with the traditional dialysis methods. The first clinical trial filtered the patients’ blood effectively, regardless of whether their diet included salty or phosphorus-rich foods, which would normally be avoided for dialysis patients.

The later iterations of the product involved having a day mode device and a night mode device. This facilitates the ability to have a smaller device that could be used during the day and a heavier one for the night that performs clinical tasks and recharges the battery.

The U.S. FDA reduced the number of clinical trials that they wanted from five to two after the first clinical trial performed successfully in 2015. Although there was increased risk for blood clotting with this device, the benefits on patients’ quality of life became crystal clear and outweighed the risk.

If you require assistance with applying for a Class II medical device licence, 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.

The post Wearable Artificial Kidney (WAK) – A Portable Dialysis Device appeared first on Focal Point.

Under these regulations, an antimicrobial agent is defined as a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined by the Medical Devices Regulations, that (a) are not invasive devices as defined in those Regulations; and (b) that are intended to come into contact with intact skin only

Why?

The reclassification is intended to improve regulatory alignment between Canada and the United States. Although these products are currently considered to be Class II medical devices, an amendment to the MDR will be pursued by Health Canada to further reclassify them as Class III medical devices in the future.

Currently Marketed Products

Health Canada is allowing authorized products to remain on the market during an 18-month transition period for manufactures to align their products with these new regulations. With approximately 6 months left until the deadline, Health Canada is aware that some manufacturers are having a hard time meeting Quality Management System (QMS) certification requirements to obtain a medical device licence for reclassified disinfectants and sterilants.

If you require assistance with applying for a Class II medical device licence, 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.

The post Reclassification of High-Level Disinfectants and Sterilant Solutions as Class II Medical Devices appeared first on Focal Point.

A risk assessment is an integral part of maintaining both the health of Canadians and the environment. Risk assessments are executed by Environment and Climate Change Canada under the CEPA (Canadian Environmental Protection Act) and are used to “determine whether there are risks resulting from exposure of Canadians to the substance or releases of the substance into the environment, and the specific ways Canadians or the environment can be affected”. The assessment of chemicals allows for proper regulatory measures to be taken.

What risks does talc pose to human health?

The assessment mainly focuses on the risks talc poses within self-care products and concludes that it be classified as CEPA toxic. This conclusion is due to two associated risks with loose powder forms of talc. One of the two risks discussed is the inhalation of talc from loose powder products. This risk encompasses products such as baby powder and industrial applications in which talc is airborne. Warning labels have already been required on products like baby powder that are marketed for the use on infants, cautioning to avoid inhalation of the product by the infant. Inhalation of talc can lead to respiratory problems including “coughing, difficulty breathing, decreased lung function and scarring of the lung tissue”. Perhaps more serious of the risks is the possible associations with ovarian cancer. When used on the perineal region in women it was found that it is possible for talc to migrate and find itself lodged in the reproductive system. This judgement comes off the heels of the July verdict of the class action lawsuit of Johnson & Johnson by 22 women who claimed consistent use of J&J Baby Powder on the perineal area had led to their ovarian cancer (due to alleged contamination of talcum powder with asbestos). Johnson & Johnson was found guilty, with the court ruling in favour of those affected. Several studies have also been conducted to observe the possible risks associated with talc, these are included in the documentation provided by CEPA. It is important to note that, in pressed form or consumables (ie. Some cosmetics or foods or drugs), Health Canada did not find talc harmful.

Where does this leave Talc?

The findings show talc as a health threat, but that it presents no threat to the environment. In terms of talc as an ingredient in self-care products; those that are non-airborne, don’t come in contact with the perineal area or are consumed are deemed safe. However, in the meantime, consumers are left to make the decision themselves if they would like to stay away from talc-based products.

Despite these published documents, nothing is set in stone until the final assessment.  A 60-day comment period has opened allowing for comments to be made upon the presented information and conclusions. If passed, the proposed conclusions published by Health Canada would result in the following outcomes as means of risk management:

• Possible modifications to the Cosmetic Ingredients Hotlist to prohibit or restrict talc and its use in cosmetics and perennial products
• Possible modifications to the Natural Health Products Database and associated monographs to reduce the exposure of talc to consumers in NHPs and OTC drugs that have risks of being inhaled or usage associated with the perineal area

Important Dates to Note

• The draft screening assessment was posted online by Health Canada on December 5^th, 2018
• A 60-day comment period has opened and will close on February 6^th, 2019

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.

The post Health Canada takes Action on Talc appeared first on Focal Point.