Frequently Asked Questions - Medical Devices Regulations
This document is an unofficial summary of the Regulations. It is not intended to substitute for, supersede or limit the requirements under the applicable legislation. In case of any discrepancy between this summary and the legislation, the legislation will prevail.
What is the purpose of this regulation?
The purpose of the Medical Devices Regulations is to help protect the health and safety of Canadians with respect to the sale of medical devices.
The term 'medical device' covers a variety of products. Examples include: toothbrushes, bandages, knee implants, blood glucose meters, surgical instruments, and pacemakers.
What are the key elements of this regulation?
Classification Rules for Medical Devices
The Medical Devices Regulations include rules to help classify devices into four risk classes. Class I presents the lowest potential harm; Class IV presents the highest potential harm.
Safety and Effectiveness and Labelling Requirements
Devices imported or sold in Canada must meet eleven fundamental safety and effectiveness requirements and must be labelled in accordance with specified labelling requirements.
Medical Device Licensing
Class II, III and IV devices must have a medical device licence before they can be sold in Canada. Class I devices do not require a medical device licence; however, they are monitored through Establishment Licences.
Establishment Licensing
Establishment licensing ensures that Health Canada is aware of the identity of establishments that are importing and/or selling medical devices or manufacturing Class I devices. In addition, it requires establishments to provide assurance to Health Canada that regulatory requirements related to post-market activities have been met.
Post-Licensing Requirements
The holder of a licence must fulfill certain requirements in order to maintain its authorization to sell a device. These requirements include: maintaining distribution records, informing Health Canada of any changes to the original licence, complaint handling, mandatory problem reporting, recall and implant registration.
Implant Registration
These provisions facilitate the tracking of certain implanted devices so that recipients of those implants may be notified of pertinent post-implant information.
Investigational Testing
Clinical trials (investigational tests) are used to determine the effects or performance of an investigational device and ascertain its safety and effectiveness. The Medical Devices Regulations provide a mechanism to authorize the sale or importation of devices to be used for the purposes of clinical trials involving human subjects.
Custom-Made Devices and Devices for Special Access
This section permits the sale of custom-made devices (i.e., devices that are made based on a physician's written direction and design for the sole use by a particular patient) and the sale or importation of devices for special access (i.e., for emergency use or where conventional therapies have failed, or are unavailable or unsuitable).
How does this regulation affect Canadian businesses?
Authorizations
There are several types of applications for authorization under the Medical Devices Regulations: Class II medical device licence; Class III medical device licence; Class IV medical device licence; medical device licence amendment; establishment licence; investigational testing (device clinical trials in humans); and custom-made devices and special access devices. Class I devices do not require a medical device licence to be sold in Canada, but manufacturers, distributors and importers of these devices are required to obtain an establishment licence.
Generally, the authorization process involves the submission of an application by a manufacturer to Health Canada, a decision by Health Canada, and an opportunity for representation should the manufacturer wish to dispute the decision.
Medical Device Licensing
In order to obtain a medical device licence, device manufacturers must submit evidence to Health Canada that the safety, effectiveness and labelling requirements for their medical device have been met.
Manufacturers of Class II, III and IV devices must also submit a quality management systems (QMS) certificate that certifies the devices they sell in Canada are manufactured and designed (for Class III and IV) in accordance with the International Organization for Standardization (ISO) standard 13485:2003.
Establishment Licensing
Importers and distributors of Class I, II, III, or IV medical devices must hold an establishment licence. Manufacturers of Class I medical devices must also obtain an establishment licence unless they import or distribute solely through a person who holds one. The establishment licensing scheme involves the submission of information to Health Canada. An existing licence continues to be valid as long as a completed Annual Licence Review application is received by Health Canada before April 1 of each year.
Investigational Testing
Manufacturers must obtain authorization from Health Canada to sell a Class II, III or IV device for investigational testing. Investigators conducting the trial must submit a written undertaking to the manufacturer that they will conduct the investigation in accordance with the manufacturer's protocol and will advise the manufacturer and Health Canada of any serious problems which may result from the investigational use of the device.
Only essential data is assessed by Health Canada for an authorization to conduct investigational testing. More detailed data supporting the device's safety and effectiveness is required as part of the application for a medical device licence. .
Custom-made Devices and Devices for Special Access
Custom made devices may be sold based on a physician's written directions and design for the sole use of a specific patient.
The Special Access provisions allow a health care professional to request access to a device that is not licensed for general sale in Canada where the device is required for emergency use or where conventional therapies have failed, or are unavailable or unsuitable. The health care professional must make an application to the Medical Devices Special Access Programme providing information about the requested medical device as well as the patient-specific medical rationale. The health care professional must also agree to inform the patient of the risks and benefits of the use of the device prior to treatment, and agree to report any serious adverse events related to the device within 72 hours of their occurrence.
Post-Authorization Requirements
Manufacturers, importers and distributors must keep distribution records and have written procedures to (a) handle complaints and investigate them, and (b) recall defective devices from the market.
Manufacturers and importers must report to Health Canada all serious problems that occurred with the use of devices following sale.
Manufacturers must inform Health Canada, on a yearly basis, of their intent to continue selling their device, and to confirm that there weren't any changes to the information contained in the original application.
The manufacturer must inform the regulator within 30 days after discontinuing sale of their medical device in Canada, in order to cancel the licence.
Implant Registration
This section requires that staff at a health care facility fill out an implant registration card containing both facility and patient information, and then provide one card to the manufacturer and one to the patient. This section also allows a manufacturer to use a method of implant registration other than the implant registration cards, if the alternate method is found acceptable to Health Canada. These requirements pertain to "implants" as listed in Schedule 2 of the Medical Devices Regulations.
What is the timeline for implementation?
Certain sections of the Medical Devices Regulations came into force in July, September and November of 1998. All sections were in force on January 1, 2003.
Where can I get more information on the Medical Devices Regulations?
Medical Devices Bureau Enquiries
E-mail: mdb_enquiries@hc-sc.gc.ca
Telephone: 613-957-7285
For More Information
To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.
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