Pharmaceuticals & Medical Devices
Facility / Establishment Licencing
Drug Establishment Licence (DEL) and Medical Device Establishment Licence (MDEL)
DEL – In Canada, the process of obtaining an establishment licence is not an easy one but that is why we are here to walk you through. In short, drug establishment licences are required to fabricate, package, label, distribute, import, wholesale, or test drugs in Canada. This licensing requirement applies to all drug establishments except those solely dealing in some natural health products, for which prescriptions are not required and that are for human use in dosage form, including traditional medicines (i.e. traditional herbal medicines as well as traditional medicines such as Chinese, ayurvedic (East Indian) and aboriginal (North American) medicines), homeopathic preparations and vitamin and mineral supplements.
MDEL – There are two types of licences for medical devices in Canada. The first is a licence for the actual device itself and the second is a licence for the establishment (company). The device licence is called a Medical Device Licence (MDL) while the establishment licence is called a Medical Device Establishment Licence (MDEL. Depending on your business model, you may need to obtain a Medical Device Establishment Licence to sell Medical devices in Canada. A Medical Device Establishment Licence is issued for the activities of importing and selling medical devices for human use in Canada. Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence.
Precursor Licences – Class A/B
Health Canada defines precursor chemicals as chemicals that are essential to the production of a controlled substance. Precursor chemicals have a wide legitimate use in the production of consumer goods such as pharmaceuticals, fragrances, flavoring agents, petroleum products, fertilizers and paints. For example, ephedrine and pseudoephedrine, commonly used in cold and decongestant medicine, are precursor chemicals that are used to produce methamphetamine. If you are a pharmaceutical manufacturer and you assemble drugs or other using precursors, you will also require a special licence for handling precursors. Getting your licence also depends on security clearance for some of your employees such as Quality Assurance person and others and also on security clearance for your storage facilities. The facility will also undergo inspection before the licence is issued. We a can help you with the application to obtain your precursor licence along with all the documentation required for continual compliance.
Drug Identification Number (DIN) & Medical Device Licence (MDL)
Premarket authorization is required before drug products are authorized for sale in Canada. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations for review by Health Canada. When a drug passes this process, it is given an 8-digit number called a DIN. Our team is experienced and available to assist you in obtaining DIN numbers for your products.
We can help determine which licence you require for your business model and whatever licence you require, we are here to assist you with the application and documentation that you require to obtain your licencing.
Pharmaceutical and Medical Device Regulatory Consulting in Canada
Manufacturing or distributing pharmaceuticals and medical devices in Canada requires strict adherence to Health Canada’s licensing framework. Global NHP Consulting provides trusted pharmaceutical regulatory consulting support in Canada, guiding companies through establishment licensing, product classification, and submission requirements. Our team helps you avoid costly missteps that delay market entry.
New drug products and medical devices each follow distinct approval pathways, and incomplete documentation causes significant delays in either case. As an experienced medical device licensing consultant, we review technical files, quality systems, and labelling against current regulations, giving your company a clear, organized path toward approval and continued regulatory good standing.
Understanding Canada's Complex Approval Pathways
Health Canada regulates pharmaceuticals and medical devices under separate but equally demanding frameworks. Drug manufacturers need proper facility authorization before production begins, while device companies must classify products correctly and demonstrate safety through appropriate evidence. Our consultants guide companies through both pathways, correcting gaps before submission rather than after rejection. Securing a drug establishment licence in Canada requires accurate facility documentation, quality assurance evidence and personnel qualifications presented correctly. We handle these details thoroughly, reducing back-and-forth communication with reviewers and keeping your product timeline realistic.
Support Covering Every Regulatory Stage
Turning Complex Requirements Into Manageable Steps
Pharmaceutical and device regulations involve extensive documentation most companies find overwhelming without experienced guidance. Our team breaks requirements into manageable stages, handling technical submissions while keeping your internal team informed throughout the process. Clients rely on our dedicated DEL application consultants in Canada for establishment licensing matters specifically, while our device team manages classification separately. We coordinate directly with Health Canada reviewers, addressing questions quickly rather than letting applications stall in review queues.
Our Pharmaceutical and Device Service Areas
Our Regulatory Categories
Establishment Licensing
We prepare complete facility documentation and quality evidence needed for licensing, presenting organized submissions that satisfy reviewers without unnecessary revision requests or delays.
Device Classification
Our specialists determine the correct device class and corresponding evidence requirements, preventing misclassification that could otherwise delay approval or trigger regulatory correspondence.
Compliance Documentation
We compile technical files, risk assessments and quality records accurately, giving your submission the organized structure Health Canada reviewers expect from every applicant.
Why Manufacturers Choose Our Regulatory Team
Regulatory delays cost manufacturers real revenue, and every missing document extends your timeline further. Our specialists bring practical experience as pharma compliance consultants in Canada that manufacturers trust for both drug and device submissions. We also support companies that need guidance from an NHP consultant for compliant production and supply of pharmaceutical products in the country. Contact Global NHP Consulting today to move your product through Canada’s regulatory system efficiently.
How Our Regulatory Process Works
A Structured Path Toward Full Approval
Our process guides your submission through assessment, documentation and review stages methodically, keeping stakeholders informed while maintaining steady progress toward final regulatory approval.
