Notice - Classification of Medical Devices Class I or Class II patient management software

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Contact Device Licensing

August 31, 2009
Our file number: 09-122095-269

Notice

Application

This notice affects:

1. manufacturers, importers and distributors of medical devices software and facilities that purchase patient management software.

Definitions

As defined in the Food and Drugs Act (the "Act"):

"device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical sate, or its symptoms, in human beings or animals,
2. restoring, correcting or modifying a body function or the body structure of human beings or animals,
3. he diagnosis of pregnancy in human beings or animals, or
4. the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug.

As defined in the Medical Devices Regulations:

"medical device" means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. (instrument medical)

"active device" means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device. (instrument actif)

"active diagnostic device" means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. (instrument diagnostique actif)

Context

Patient management software fits the definition of a medical device, and must therefore be classified in accordance with the classification rules for medical devices from the Medical Devices Regulations.

There has been a degree of uncertainty regarding the classification of patient management software among interested stakeholders wishing to manufacture, import or distribute such devices in Canada. To aid in the consistent and accurate classification of patient management software, the Medical Devices Bureau has established a definitive classification system. The Medical Devices Bureau has adopted the following approach in order to ensure that the potential risk of a medical workstation and/or any dedicated software is reflected in its classification.

Patient management software is considered an Active Device because it relies on a source of energy other than energy generated by the human body or gravity.

Any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device based on Rule 12 of the Medical Devices Regulations.

Rule 12:
Any other active device is classified as Class I.

However, any patient management software with capabilities beyond basic data visualization is considered a Class II medical device based on Rule 10 (1) of the Regulations.

Rule 10:
(1) Subject to subrule (2), an active diagnostic device, including any dedicated software, that supplies energy for the purpose of imaging or monitoring physiological processes is classified as Class II.

These are considered Active Diagnostic Devices because they are used for the purpose of monitoring a physiological condition, state of health, illness or congenital deformity. This includes any patient management software involved in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing, flagging of results or performing calculations. Any primary workstation that interfaces directly with a system (imaging or other type) by acquiring data and then sending data to an image generating, viewing or storage device, is also classified as Class II.

If manufacturers previously received a Class I ruling from Health Canada, but their software now falls into Class II (as defined above), a one year transition period will be granted to the manufacturers in order to be able to meet all the regulatory requirements outlined under Section 32(2) of the Medical Devices Regulations. This transition period is effective as of the date of this notice.

Additional Information

For additional information on patient management software, please contact the following:

Device Licensing
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605, Statistics Canada Main Building
Tunney's Pasture, Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Telephone: (613) 957-7285
Facsimile: (613) 957-6345
E-mail: device_licensing@hc-sc.gc.ca