The response is based on the CDA Guidance Document Pertaining to Devices for Use in Dental Health Care.
Context
- The instruments, equipment, and materials used by dentists are considered to be medical devices by Health Canada and must comply with Canadian Medical Devices Regulations in order to be sold and used in Canada.
- This Canadian Dental Association (CDA) document provides guidance to dentists concerning the purchase of dental instruments, equipment and materials and reporting of adverse incidents related to devices used in the practice of dentistry.
- The purpose of the Medical Devices Regulations (1998) is to improve the safety, effectiveness and quality of medical devices sold in Canada and to bring Canada’s regulations in line with those of our major trading partners. An important feature of the 1998 regulations was the establishment of device classes and requirements for manufacturers, importers and distributors to obtain appropriate authorization prior to the sale of medical devices in Canada.
Summary of Key Points for Dentists
- Class I devices do NOT require a device licence.
- Class II, III and IV devices sold in Canada must have a device licence.
- Health Canada’s MDALL searchable online database (www.mdall.ca) is a reference tool to determine whether a device has a licence to be sold in Canada.
- Importers and distributors of devices are required to obtain an Establishment Licence from Health Canada.
- Canadian dentists have an ethical responsibility to use products that are for sale legally in Canada.
- Dentists should follow manufacturer’s instructions to ensure that the device will be used in a safe and effective manner, and to minimize risk of harm to either the user or patient.
- Any serious or unexpected adverse incident related to devices should be reported to Health Canada.
Resources
FAQs Regarding Devices for use in Dental Health Care
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