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.

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.