Health Canada's MDEL is specific to the establishment involved in importing, distributing, or selling medical devices. Understanding the key differences between the MDEL and other regulatory approvals is important to ensure compliance with the applicable requirements.
1. MDEL vs. Medical Device License (MDL): The MDEL is specific to the establishment, while the Medical Device License (MDL) is specific to the medical device itself. The MDL is required for Class II, III, and IV medical devices and is obtained through a separate application process. The MDL demonstrates that the specific medical device meets safety and effectiveness requirements.
2. MDEL vs. ISO Certification: ISO certification, such as ISO 13485, is a voluntary certification that demonstrates compliance with internationally recognized quality management system standards. While ISO certification is not a requirement for obtaining an MDEL, it can be beneficial in demonstrating your establishment's commitment to quality and compliance.