MEDICAL DEVICE ESTABLISHMENT LICENCE
(MDEL)
Why Panabistics as Your MDEL Holder?
Services Overview
-
Specialized Expertise: With a team well-versed in the intricacies of Health Canada's regulatory landscape, Panabistics provides precise guidance tailored for Class I medical devices.
​
-
Simplified Compliance: As your MDEL holder, Panabistics shoulders the responsibilities of licensing, ensuring your devices align perfectly with the Canadian Medical Devices Regulations (CMDR).
​
-
Unwavering Support: Panabistics stands by you, offering continual guidance and support, addressing queries, and assisting with renewals, ensuring an unbroken market presence.
​
-
Cost-Efficient Solutions: Utilizing Panabistics as your MDEL holder can lead to substantial savings, eliminating the need for individual applications and associated fees.
​
-
Relationships with Health Authorities: Our seasoned relationship with Health Canada paves the way for smoother communication, prompt responses, and efficient problem-solving.
-
Complete management of the MDEL application and renewal processes.
​
-
Regular monitoring and updates regarding Health Canada regulations and guidance, ensuring constant compliance.
​
-
Addressing inquiries or issues raised by Health Canada on behalf of manufacturers.
​
-
Offering advisory services for labeling, advertising, and promotional material in accordance with Canadian requirements.

Experience Seamless Market Access with Panabistics
Position your Class I medical devices seamlessly within the Canadian market with Panabistics by your side. Benefit from our unparalleled expertise and our unwavering commitment to ensuring your success.