Canadian Medical Devices Regulations
In Canada, medical devices have been categorized (Class I to IV) based on the risks associated with their use. Manufacturers must receive a medical device licence for certain health products defined as a "device" under the Food and Drugs Act before they can be sold on the Canadian market. Although Class I devices do not require a licence, manufacturers, distributors and importers are required to obtain an establishment licence.
Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system
The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003.
How can Innovia Biopharma help you?
✪ Preparation, filing and follow-up of Medical Devices market authorization (Medical Device Licence) submissions with Health Canada.
✪ Guidance and assistance with your Medical Device Licence submissions to Health Canada.
✪ Preparation, filing and follow-up of Medical Device Establishment Licences (MDEL) submissions and amendments.
✪ Guidance and assistance with your Medical Device Establishment Licence submissions (MDEL) to Health Canada.
✪ ISO-13485 Quality Management system implementation
✪ SOP writting
✪ Internal & external audits
BUSINESS & MARKET DEVELOPMEMENT
✪ Due Dilligence for Merger & Aquisition
✪ Opportunities identification