Therapeutic Products Programme Programme des produits thérapeutiques OUR MISSION: To ensure that the drugs, medical devices, NOTRE MISSION: Faire en sorte que les médicaments, lesmatériels and other therapeutic products available in Canada are safe, médicaux et les autres produits thérapeutiques disponibles au Canada effective and of high quality. soient sûrs, efficaces et de haute qualité. Therapeutic Products Programme Keyword Index To Assist Manufacturers In Verifying The Class of Medical Devices For more information please contact: Don Boyer Licensing Services Division Medical Devices Bureau 1605 Statistics Canada Main Building, Postal Locator: 0301H1 Tunney’s Pasture, Ottawa, Ontario K1A 0L2 phone: (613) 957-7090 fax: (613) 954-7666 e-mail:
[email protected] Therapeutic Products Programme Medical Device Keyword Index DRAFT Introduction The Medical Device Keyword Index was prepared to assist manufacturers in verifying the device class for products after application of the Classification Rules for Medical Devices of the Medical Devices Regulations. The Index should also be used in conjunction with the guidance document “Guidance For The Risk Based Classification System, GD006/RevDR-MDB.” Please note that this document is provided as a guide and that in the event of any discrepancy between this guide and the Classification Rules for Medical Devices of the Medical Devices Regulations, the latter shall prevail. What is a Keyword Index? The Medical Device Keyword Index is an alphabetical listing of all the words which appear in all the short descriptors for all the device groups that have been identified by the Medical Devices Bureau. It contains synonyms and industry words that are commonly used to describe the products in these device groups.