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.

The post Health Canada’s proposed updates to the MDEL guidance documents 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.

Per the Foreign Risk Notification sections of Medical Device Regulations, any notifiable actions initiated by manufacturers or regulatory agencies to mitigate a serious risk of injury to human health in specified foreign jurisdictions (List of Regulatory Agencies) must be reported to Health Canada. This reporting requirement is applicable to:

• A medical device licence holder (including private label manufacturers) for a Class II to IV device.
• An establishment licence holder that imports Class II to IV devices (“importer”)
• A holder of an authorization under subsection 83(1) of the Regulations (Investigational Testing Authorization)

Please note that manufacturers are responsible for ensuring that all the submitted information in FRN reports are complete and accurate, even if the importer has been permitted to report on the manufacturer’s behalf.

Notifiable action relating to safety to be reported constitute any action (e.g., public risk communication, labelling change requested by regulators, recall, reassessment/ suspension /revocation of an authorization) taken by a foreign regulator or authorization holder in certain foreign jurisdictions.

Authorization holders are required to submit the completed Medical Device Foreign Risk Notification Form within 72 hours of when they become aware of a notifiable action.

If you need further information or require help in completing a Foreign Risk Notification Form, please contact us.

The post Foreign Risk Notification (FRN) 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.

At the beginning of the Covid 19 pandemic, there was tremendous panic because of the shortages of Personal Protective Equipment of all types. Since then, most countries have ramped up production of all types of equipment for both medical professionals and the public at large.

During the past year, the scientific community learned that Covid 19 spreads through droplet transmission in the air rather than on surfaces. This is caused a dramatic shift away from hand and surface sanitization to protecting individuals from inhalation of the virus. Recently several companies have developed new and higher performing products that not only claim to work better than basic facemask technology, they also offer superior comfort. One is a hood/helmet type product, the other a complex face mask.

Vyzr Technologies in Toronto Canada (www.vyzrtech.com) has developed the Biovyzer. Their product is a Powered Air Purifying Respirator (PARP) which is essentially a hood that slips over the head and contains the entire airspace around the head. It is a battery-operated device that cleans incoming air through a filtration system, and again filters outgoing air. It has an innovative “glove” that allows the wearer to scratch the face, adjust their glasses etc. At a cost of $379 plus shipping, it may be out of reach for many consumers but it offers a high-tech solution that could fill a major niche in healthcare, commercial and industrial settings. It could also be a game changer for immunocompromised individuals.

Another interesting innovation comes out of Florida’s Octo Safety Devices (https://octosafety.com/pages/the-octo-respirator-mask). Their product is more of a face mask, but with several interesting, innovative features. It is a multicomponent mask with a reusable, cleanable filter. The filter uses silver particles for antimicrobial effectiveness. There is a soft silicone skirt that sits against the face which would appear to be both comfortable and able to provide an effective seal. The product also has a mouth vent which the manufacturer claims that it allows people to speak more easily through their masks. At $107, it is also a premium product but one that could be well worth the cost if it performs as the manufacturers describe.

These are just two examples of the countless innovations in development since the beginning of the Covid 19 pandemic. Both companies mentioned here are small, innovative businesses who deserve much credit for their work.

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 Face Masks – Innovation and Opportunity appeared first on Focal Point.

The investigators conducted a randomized, double-blind placebo-controlled phase II clinical trial at nine sites in the UK. The trial was done with 98 patients who were hospitalized with Covid-19. In the treatment group, Interferon Beta 1a was inhaled from a nebulizer for 14 days, versus placebo in the control group.

Patients in the treatment group were twice as likely to recover clinically at day 15 or 16: 21 of 48 (44%) versus 11 of 50 (22%) in the control group. Eleven of the 50 patients in the control group became severely ill or died compared to 6 of 48 in the treatment group. None of the patients in the treatment group died. However, the odds of hospital release at day 28 was not significantly different between the two groups.

Interferons are proteins that are created in response to viral infections. Interferon beta is a protein that coordinates the immune response to viral infections such as COVID-19, however the coronavirus suppresses its release. It is also known that some severe Covid-19 patients have antibodies against another important Interferon, Interferon Alpha. The theory behind the inhalation of Interferon Beta is to simply replace the lung’s supply of interferons by inhaling it directly into the lung.

This study clearly showed great promise, but further work is needed to confirm both the safety and effectiveness of Interferon Beta 1a.

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 Interferon Beta 1a: Potentially Promising Treatment for Covid-19 appeared first on Focal Point.

The decline in the biomedical technology industry was seen in the last weeks of March due to an overall decline in sales, procedures, and testing. As well, many hospitals restricted their surgeries to only necessary surgeries to preserve resources and staff. This resulted in great losses for hospitals and suppliers. However, the losses for hospitals continued through the cost of increasing PPE, reconfiguring spaces, new medical equipment, and the need for increased labor. Although some hospitals have started to allow elective surgeries to begin, such as hospitals in China, the surgery rate has not returned to its normal amount. It has been theorized that this is from consumer hesitation and concern of safety. Therefore, although the decline is lessening, it may still be a while until the biomedical technology industry and hospitals return to normal. 

With that being said, certain biomedical technology companies have actually experienced a dramatic increase in sales in certain departments. Companies that were already producing products that could aid in the coronavirus pandemic, such as assistive breathing and intensive care devices, have experienced an increase in profit caused by the high demand.  For example, Hillrom, a producer of non-invasive ventilators, patient monitoring devices, and smart beds, experienced an extreme increase in sales. In fact, the company increased ventilator production by fivefold and are hiring temporary and permanent employees. 

Other biomedical technology companies have experienced a market gain through the creation of precautionary medical equipment, such as Hologic. Hologic developed a SARS CoV-2 diagnostic test that is compatible with many hospital’s systems. The test produces results within three hours. Since the release of the test, the company has experienced their highest groth rate in eight years and has increased their production of the tests by 12-fold. 

People have recognized this ability to succeed in the biomedical technology industry during this time, but some people have been dishonest when trying to find success. As such, the US FDA has seen an increase in fraudulent products. An explanation of the US FDA’s guidance for innovators and researchers can be found  here. Therefore, although the biomedical technology field can help greatly during this difficult time, it is important to remember the regulatory steps required in the process. 

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 COVID-19 Impacts on Biomedical Technology Industry appeared first on Focal Point.

However, due to the short-term success of meeting demands, Health Canada has recently announced the ending of two of the interim regulations for the hand sanitizer and disinfectant product regulations; allowing unilingual labelling for hand sanitizers being sold within a unilingual region and turnaround time of 24 – 48 hours for site licence and product licence applicants. All labelling for hand sanitizer and disinfectant products in Canada must immediately change their labelling to be in both English and French. Those who are currently licensed have until June 8, 2020 to comply with bilingual labelling requirement. All new products going forward will have to comply with this immediately. Please refer to the monograph for the complete labelling regulations for hand sanitizers. As well, the previous quick turnaround time of 24 – 48 hours for site licence and product licence applicants has been removed too. The new regulation states the turnaround time is now approximately 5 – 7 days. This was outlined in Health Canada Bulletin #17 – dated May 14, 2020.

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 Revisions to Health Canada’s COVID-19 Hand Sanitizer and Disinfectant Interim Policies appeared first on Focal Point.