Health Canada’s Special Access Program for Medical Devices

by | Dec 23, 2020 | FDA, Health Canada, Medical Devices, Quality

Part 2 of the Canadian Medical Devices Regulations under the Food and Drugs Act allows for health care professionals to request the use of custom-made and unlicensed medical devices on patients.1 To be eligible to receive this special access, the health care professional must be licensed to provide health services under the laws of that province and that these medical devices are to be used:1

  • for emergency use only or
  • when conventional therapies have failed, are unavailable, or are unsuitable to treat a patient


The following medical devices are eligible for this application and can be requested either for a specific patient or in batches. Application for batches will only be considered when shipping delays will cause negative outcomes to the patient/s and the batch quantity requested is enough for a month’s emergency use of the patient or group.1

  • class I, II, III or IV medical devices
  • class III or IV custom-made devices and
  • It must be a device that is currently not authorized for sale in Canada


For devices that are custom-made for a patient, the application must include the drawings/sketches that explain the design of the device. Health Canada analyzes the risk-benefit ratio of the device and grants an authorization based on several factors such as the medical condition, information on the device’s safety and effectiveness, patient-related information, etc. Even after an authorization has been granted, a manufacturer is not obligated to sell the product under a special access program and reserves the right to deny the sale of such devices.1

Under this program, health care professionals are still required to abide by the mandatory reporting requirements for medical devices and must submit serious adverse reports to Health Canada, the manufacturer, and the importer within 72 hours.1

There are many such programs available by several regulatory authorities to help protect patient health. To know more about this program or any other Health Canada regulation call us today at +1 2489874497 or email us at

1Health Canada (Oct 2020) Health Canada’s special access programs: Request access to a medical device retrieved on 12/20/2020 from

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).

Ready to learn more about working with us?

Pin It on Pinterest

Share This