If you’re considering a future in pharmaceutical regulatory affairs, you’ll want to stay on top of the latest regulatory changes affecting the pharmaceutical industry. One of the biggest such changes currently underway is Health Canada’s Action Plan on Medical Devices. This action plan is a set of reforms governing the safety, quality, and effectiveness of medical devices used and sold in Canada.
The reforms are being rolled out this year and they include some significant shifts in how medical devices are approved and how incidents involving such devices are reported. Let’s take a look at a few of the most important items in the action plan.
Students in Drug Regulatory Affairs Training Should Know About New Reporting Requirements
Hospitals in Canada will now be required to report incidents involving medical devices to Health Canada. Previously, only medical device manufacturers and importers were required to report such incidents, which Health Canada says has led to underreporting of medical device problems in Canada. That has meant that devices that have been banned in other countries have occasionally been available for years afterwards in Canada because of a lack of reporting about their potential problems.
Health Canada is also aiming to increase reporting on medical device incidents from health care facilities outside of hospitals, such as long-term care facilities and private clinics. While reports from non-hospital health care facilities will be voluntary at first, the health agency says they may become mandatory if reporting from them doesn’t increase.
Manufacturers also face new reporting requirements, which you should be aware of it you pursue employment with a medical device manufacturer after your pharmaceutical regulatory affairs diploma. In accordance with the action plan, manufacturers must now report to Health Canada within 72 hours if a foreign regulator finds an implant poses a serious health risk.
Health Canada Will Increase Regulatory Site Inspections in Canada and Abroad
As you’ll learn in drug regulatory affairs courses, good manufacturing practices (GMP) are an essential element of ensuring that drugs and medical devices are manufactured according to rigorous safety regulations. To ensure that manufacturers are following those regulations, Health Canada says it will be stepping up its inspection and validation programs for facilities and companies that manufacture, import, or distribute medical devices. The agency will increase the number of on-site inspections it conducts by hiring an additional 8 inspectors and 2 investigational analysts by March 2019. Beginning in April 2019, Health Canada will also increase its foreign site inspections from 80 to 95.
More Regulatory Evidence Supporting Medical Devices Will Be Made Public
Access to information concerning medical devices will also increase substantially. Health Canada says that both patients and doctors will have increased access to the evidence and clinical information that help get medical devices approved for public use. Such data was previously only made available through Access to Information requests. Greater access to that data, the health agency contends, will allow for more independent analysis of the approval process for medical devices and allow Canadians to make more informed health care choices.
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