Once you have an MDEL Licence, it is important to keep a close eye on the rules and regulations related to operating with a medical device establishment licence. All establishments must maintain records of activities such as distribution records, complaint handling, and recalls r. The products made or sold by the company should comply with Health Canada requirements and be regularly inspected to ensure their safety and effectiveness. Moreover, the licensee must report any changes made within their establishment that could have an impact on product quality or integrity.