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MEDICAL DEVICE ESTABLISHMENT LICENCE
Medical Device Establishment Licensing (MDEL) is covered by Sections 44 to 51 of the Medical Device Regulations as found in the Food & Drug Regulations (FDR). With some exceptions, most companies who import or sell devices for human use (other than for personal use) will require a license.
MEDERA can help you determine if licensing requirements apply to you. Required companies must apply to receive a Medical Device Establishment licence (MDEL). MEDERA can handle the licensing applications on your behalf.
MEDERA will work with you to determine which licensing requirements apply to your firm. Activities and product lists are reviewed to determine the impact of the medical device regulations on your firm.
If medical device licenses are required for your products, MEDERA will work with you to determine product registration requirements.