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You've invented an innovative health-care product. What's the prescription for getting it into hospitals, drug stores, and other facilities?

Before any medical device can be sold in this country, it must be licensed by Health Canada's Medical Devices Bureau. When a company applies for a licence, the agency places the product into one of four classes, based on the potential to cause harm if the device malfunctions.

Class I represents the lowest risk and Class IV the highest. Examples of each category include:

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Class I: Bandage, toothbrush, hospital bed.

Class II: Hygienic tampon, surgical gloves, magnetic resonance imaging equipment.

Class III: Home glucose test kit, hip replacement implant, ultrasound diagnostic imaging equipment.

Class IV: HIV test kit, implantable defibrillator, pacemaker.

While Class II, III and IV must have a Medical Device Licence, lower-risk Class I devices are monitored through establishment licences that ensure Health Canada knows who is selling and manufacturing the devices. In the case of Prodaptive, inventors of the Stal, it has to be able to track every product sold. If there's a recall, the manufacturer must be able to retrieve every last device sold. This also applies to Class II to IV devices.

If a medical device is not approved, the manufacturer/distributor/importer can appeal or apply again with additional information.

Health Canada says it takes anywhere from 15 to 90 calendar days to review a medical licence application, but as in Prodaptive's case, it can actually take longer. Health Canada charges $350 to $20,000 to review medical devices.

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Once the manufacturer acquires a licence it, or a distributor, can sell the product. Prodaptive is using two distributors, one in Canada, one in the United States, where Food and Drug Administration approval was required.

Special to The Globe and Mail

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