His Excellency, the Governor General in Council, by the recommendation of the Minister of Health, pursuant to the Food and Drug Act, brought forth what was meant to be an answer to a common problem. Medical devices that were sold in Canada needed to be researched and regulated for the safety of the users. Regulations got passed that apply that the sale and advertising of medical devices, and the importation of medical devices. The rules also apply to in vitro diagnostic tools or products, as if the product were an in vitro diagnostic device themselves. Food and Drug Regulations, Controlled Drugs and Substances Act, and the Narcotic Control Regulations all state pretty clearly that you are to stay away from illegal and non-prescribed drugs.
Another part of this restrictions and regulations involves gas piping that get assembled on site. A requirement of the National Standard of Canada is Non-flammable Medical Gas Piping installed on premises.
Canada classifies medical devices in more than one way. It is the manufactures obligation to ensure that the medical device meets, or exceeds, the safety and effectiveness requirements. More objective evidence must establish the medical device meets the requirements for use. A medical device should be designed and manufactured to be safe. This manufacturer and the National Standard of Canada will take measures to figure out what risks are integral.
A medical device should be designed and its parts manufactured. If the total risk cannot be eliminated, attempts to reduce risks, provides for some protection from potential failures. A medical device should perform as intended by the manufacturer and should be effective for the medical conditions and purposes represented.
During the life of a medical device, the performance should not deteriorate under normal use. Considering the manufacturer’s instructions and information, the design, manufacture, and packaging of a medical device shall minimize as much risk to the patient as possible. Sterilized medical devices should be validated to prove cleanliness.
Clearly printed on the label should be information about the device. The name of the product, name and address of manufacturers, and a small indication about what the product contains should all be clearly visible. You will need to fill out an application for a Medical Device License. The manufacturer, importer, and distributors of your medical device can each maintain a distribution record in respect to the device.
You can file some of your distribution records, do any complaint handling that might be available, be part of a recall, and have your implant registered. These are all important things to do. Some medical devices are intended for the use with sterilizing blood, body tissues, and organs that wait for transfusion or transplantation. Implants can come in a variety of different shapes and sizes. First, the heart valve is a part of your body you should take good care of at all times, though you can get a replacement valve. You can install a pacemaker, a defibrillator, artificial heart, ventricular support system, and, an item that will not soon be forgotten, an implantable drug infusion system.
By controlling regulations of medical products in Canada, the patients are safer and products sold are more effective. They manage document control, management responsibilities, and management of resources to help your product become a realization. They focus on monitoring, measurements, and how to make future improvements once the initial decision has been made. It may be a long and hard process, but getting your medical device approved for use can get you started making money off your creation.