HEALTH CANADA OFFERS DEVICE FIRMS STEP-BY-STEP GUIDANCE ON APPLYING FOR A LICENSE
A new draft guidance issued by Health Canada walks manufacturers through the various requirements of obtaining a license to market a Class II, III or IV medical device.
The guidance covers any new Class II, III or IV device not sold or imported in Canada as of July 1, 1998, licensed devices that have been modified since the original application and investigational devices that are now being offered for general sale. Class I medical devices do not require licensing prior to their importation or sale in Canada.
The document, "How to Complete the Application for a New Medical Device License," includes information on payment of applicable license fees and is accompanied by draft application forms for new and amended device licenses. When finalized, the guidance will replace a 1999 version, Health Canada said.