MEDICAL DEVICE ESTABLISHMENT LICENCE
(MDEL)
Why Panabistics as Your MDEL Holder?
Services Overview
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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.
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Simplified Compliance: As your MDEL holder, Panabistics shoulders the responsibilities of licensing, ensuring your devices align perfectly with the Canadian Medical Devices Regulations (CMDR).
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Unwavering Support: Panabistics stands by you, offering continual guidance and support, addressing queries, and assisting with renewals, ensuring an unbroken market presence.
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Cost-Efficient Solutions: Utilizing Panabistics as your MDEL holder can lead to substantial savings, eliminating the need for individual applications and associated fees.
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Relationships with Health Authorities: Our seasoned relationship with Health Canada paves the way for smoother communication, prompt responses, and efficient problem-solving.
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Complete management of the MDEL application and renewal processes.
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Regular monitoring and updates regarding Health Canada regulations and guidance, ensuring constant compliance.
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Addressing inquiries or issues raised by Health Canada on behalf of manufacturers.
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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.