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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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

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As outlined on their website here, Health Canada is asking the following from Market Authorization Holders:

· To review their products and manufacturing processes for the possible presence of nitrosamines

· To take any necessary measures to ensure that their products do not contain nitrosamines at levels exceeding the accepted limit

· To test products if a risk of nitrosamines is identified

· To immediately report to Health Canada if nitrosamines are detected

More specifically, it is now recommended that all Market Authorization Holders “work with API and drug manufacturers to review their API and drug product manufacturing processes [and] conduct risk assessments, taking into account their knowledge of the manufacturing processes, potential sources of contamination and any other root causes of formation and presence of nitrosamine impurities”. As outlined in their question and answer document, Health Canada has stated that when a nitrosamine impurity is detected at any level during a risk assessment, you are to inform them immediately, as well as submit any available details of the risk assessment to them. In all other circumstances, risk assessment documentation should be retained by the Market Authorization Holder. However, it should be noted that Health Canada can request to review the MAH’s risk assessment report for any product and will request this information directly from the MAH, as necessary.

At the time, this information pertains only to “human pharmaceutical products containing chemically synthesized active pharmaceutical ingredients (APIs), including prescription and non-prescription (over the counter) drug products” as well as “chemically synthesized excipients and raw materials used in the manufacturing of drug products, and drug products that have been approved but are not yet marketed”. Therefore, products that fall under the classification of cosmetics or natural health products are not affected by these changes at this time.

Health Canada has stated that “Nitrosamines are not expected to cause harm when ingested at low levels. For example, a person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer. As the health risk is associated with long-term use of a contaminated drug, Health Canada continues to underscore that people who take prescription sartan, ranitidine and nizatidine drugs affected by this issue, including recalled ranitidine and sartan drugs, should continue taking their medication until they have obtained an alternative treatment from their health care provider. Not treating a condition may pose a greater health risk than

potential nitrosamine exposure.” If you are a patient concerned about these new changes or that your medication may be affected by these updates, Health Canada advises you to contact your health care provider for more information.

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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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.

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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.

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Omron Healthcare Inc. has recently disclosed a new feature that allows Amazon Alexa devices to take blood pressure readings, as well as compare them to other readings taken over time. Amazon Alexa users can ask simple questions about their blood pressure, and receive information about their cardiovascular health from the comfort of their own home.

How can it be used?

The new technology can be accessed through the Omron Connect app used in conjunction with the Alexa app, both of which can be downloaded for free from Apple iOS or the Google Play store. They can sync with Omron’s blood pressure monitors, and provide information on average readings, or judge the readings against the last highest/lowest recorded readings, and much more. It also allows Alexa to provide guidelines for measurement to ensure the readings are taken accurately, making the monitoring of blood pressure easy for patients new to the practice.

For those without adverse health conditions, regularly monitoring blood-pressure with Alexa can provide insight on cardiovascular health conditions for proactively taking health into one’s own hands. It can help one act sooner on obscure numbers and can potentially be life-saving.

Omron Healthcare European president and CEO André Van Gils said: “It’s more important than ever for us to find new ways to help people simplify and ease their blood pressure monitoring habits, so that they can understand and manage their condition more efficiently.”

This new cardiovascular health monitoring addition to Amazon Alexa has consumers wondering what Amazon will come up with next.

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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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.

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The study was performed by the University of Surrey and involved the irradiation of subjects with whole-body blue light at 450nm, roughly comparable to that of a dose of sunlight. Unlike its cousin ultraviolet (UV) light, blue light is non-carcinogenic and does not share the potential cancer-causing concerns. The results of the study showcased a significant decrease in systolic blood pressure comparable to the effects seen with medication targeted to have similar effects for those with hypertension.

A surprise to the unassuming consumer, blue light’s reputation may see a shift from positive to negative as more and more studies are aimed at finding natural treatments to common physical ailments and shortcomings. A potential solution to those who are difficult to treat with oral pill form solutions for hypertension, this study showcases a potential solution to a common disorder that affects hundreds of thousands of people each year.

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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Cosmetovigilance can be described as the careful post-market surveillance of cosmetic products after they have been made available to consumers.  More simply put it can be defined as monitoring cosmetic safety.  Similarly to the concept of pharmacovigilance associated with drugs, cosmetovigilance employs the principles of post-market monitoring to keep record of adverse reactions to products. Monitoring these unintentional and un-desirable effects is a key aspect of successful marketing of these products.

What is the importance of cosmetovigilance?

Cosmetovigilance is especially important because the safety and clinical trial testing of cosmetic products are under less scrutiny by regulators than other products such as drugs, natural health products and medical devices.  This makes monitoring and reporting observed adverse effects important. There are no forms of pre-market approvals for cosmetic products in the United States or Canada (with the exception of batch certification of certain colour additives in the US), allowing these products to be easily introduced to market. The effectiveness and safety of cosmetics are entirely left to the discretion of the manufacturer, which may include testing, but it is not a requirement. As such, proper incident reporting post-market is of the highest importance. With a proper system in place problems can be identified early and changes made, limiting the size of the population affected.

Where does the responsibility to uphold/enforce cosmetovigilance fall?

The responsibility to ensure that a safe product is being marketed falls upon the manufacturer. They should be aware of risks, if any, associated with their product before releasing it into market place and if needed make consumers aware of these risks.  When it comes to the reporting of adverse effects from the use of a product the responsibility falls both on the manufacturer and the consumer. Throughout the years, cosmetovigilance has proven to be a vital tool for protecting consumers from negative side effects of products.  A common product in Asian countries, skin lightening creams have had an increase in popularity in recent years.  Lighter complexions are seen as true beauty in these regions, leaving consumers willing to do anything to achieve the ideal complexion.  Risky but effective, there are many different products on the market capable of being used to help accomplish this, from creams and gels all the way to injections (considered as illegal drugs). However, some of the raw materials contained in these products can be dangerous and have permanent damage to internal systems. One concerning additive in question in these formulations is mercury. Mercury is banned from cosmetics in nations such as the European Union and other nations such as the US and Canada have strongly enforced concentration limitations.  Despite wide scale bans, mercury is still popping up in formulations and these dangerous products are being smuggled into countries or sold online. The use of these mercury-containing products also does not solely affect the individual using it. Traces of this dangerous substance can easily be passed to unsuspecting bystanders that encounter that individual and even into water supply. In 2016 the FDA stressed the importance that these products stop being used. Without proper post market evaluation, investigation and regulation its possible that many of these products would be remain easily accessible to consumers, contaminating their homes and more importantly their bodies.

What effects can proper cosmetovigilance have on industry?

Keeping track of adverse effects from cosmetics is what can often lead to certain ingredients being restricted or prohibited by regulators. Manufacturers may even choose to pull a product from shelves if an increasingly high number of complaints is received. If consumers are seen to experience sensitising effects from certain ingredients the rules surrounding that ingredient may be amended. In short, without proper cosmetovigilance, vital changes to both product availability and regulation would be less frequent.

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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Pharmacovigilance is defined by the World Health Organization as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. In simpler terms, pharmacovigilance can be defined modestly in two words, drug safety. The study of drugs and their associated risks and effects does not simply end after lengthy studies and clinical trials.  Long after their development phase it is important that their ongoing effects and interactions with consumers continue to be monitored.

What is the importance of Pharmacovigilance and what are its effects?

A necessary step for not only prescription drugs but those less heavily regulated like OTC drugs, pharmacovigilance helps to monitor the safety of these products after consumer consumption. Recently, it has been seen that the FDA is choosing to crackdown on the safety of certain medications.  It was reported by USA Today that the FDA had begun an intensive investigation into certain blood pressure medicines with suspicions of contamination by cancer-causing impurities. These further investigations are essential to ensure the safety of consumers. With recall of medications that exhibit serious side effects or signs of contamination, the health and safety of consumers can be protected.

What is the Importance of Adverse Reaction Reporting to Pharmacovigilance?

A key aspect of pharmacovigilance is adverse drug reaction reporting. A strong determining factor in the longevity of products in market place, the reporting of these reactions is pertinent to maintaining consumer health. Without adverse reaction reporting, products that are otherwise unsafe for consumers may slip through the cracks and be left accessible to more consumers. No truer example of its importance, the 1960s thalidomide disaster that resulted in severe birth defects is a prime example of the importance of pharmacovigilance. Originally prescribed to treat morning sickness in pregnant women, this drug was seemingly harmless. Without a proper recall of this dangerous drug more and more unsuspecting expecting mothers, would have been susceptible to traumatic effects of this drug. In fact, it was this disaster that further spurred Health Canada to more tightly regulate and monitor prescription drugs and their release into marketplace. Proper regulation before and after market of drug products can ensure that disasters like this one do not occur.

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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