All medical devices required licensing from Health Canada authorization to sell in the Canadian market. A medical device manufacturer must have ISO 13485 certification via designated Canadian certification agencies. In addition, the manufacturer must have an importer and distributor that has an establishment license to take responsibility for their products. The Canadian importing and distribution company must also have ISO 13485 procedures and processes to handle the importing, warehousing, logistics, distributing and tracing of medical device products.
Cyctek has helped a number of companies develop their establishment licensing procedures, and assist them in their annual self-auditing and on-site auditing processes and compliance activities. We specialized in the Canadian requirements on operations and problem reporting processes. We helped companies develop their process and procedures, obtained Establishment Licenses and government on-site audit process. Our staff are trained in ISO 13485 and experienced in medical device hardware and software certification requirements, self-auditing, recall operations and reporting.