[Home](/)/[Resources](/resources)/Canada Drug-Device Combination Products CanadaMedical Devices # Canada Drug-Device Combination Products: Health Canada Classification and Regulatory Pathway Combination products sit at the boundary between two distinct Health Canada regulatory frameworks — the Medical Devices Regulations and the Food and Drug Regulations. Getting the classification right determines your submission type, timeline, and post-market obligations. This guide explains the primary mode of action test, the lead-centre determination process, and how constituent part submissions work in practice. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fcanada-drug-device-combination) At a glance Regulator Health Canada Frameworks Medical Devices Regulations vs Food and Drug Regulations Key question Primary mode of action Decision Health Canada classification ruling ## Classification framework for combination products ### What Counts as a Drug-Device Combination Product A combination product in the Canadian regulatory context is a product that combines a drug (or biologic) with a medical device in a single integrated or co-packaged unit, where the combined presentation is intended to achieve the therapeutic or diagnostic purpose. Classic examples include: drug-eluting stents (drug plus implantable device), pre-filled autoinjectors (drug formulation plus delivery device), antimicrobial-coated catheters (drug coating plus device), and combination diagnostic kits (reagent plus collection device). Products where the device and drug are sold separately and combined at the point of use are typically regulated independently under each framework. ### Primary Mode of Action (PMOA) Classification Test Health Canada determines which regulatory framework governs a combination product based on the product's primary mode of action (PMOA) — the mechanism through which the product's intended therapeutic effect is principally achieved. If the PMOA is physical or mechanical (e.g., a stent physically holds a vessel open and the drug merely reduces restenosis), the Medical Devices Regulations apply and the Medical Devices Bureau leads. If the PMOA is pharmacological, immunological, or metabolic (e.g., the drug achieves the primary therapeutic effect and the device merely delivers it), the Food and Drug Regulations apply and the Therapeutic Products Directorate or Biologics and Genetic Therapies Directorate leads. ### Medical Devices Bureau vs Therapeutic Products Directorate Pathway When the Medical Devices Bureau (MDB) leads, the sponsor submits a Medical Device Licence (MDL) application under the Medical Devices Regulations. The device is classified under Classes I–IV based on risk; Class III and IV devices require pre-market review. The drug constituent is addressed through a Constituent Part submission reviewed in consultation with the drug directorate, but the primary regulatory instrument is the MDL. When the Therapeutic Products Directorate (TPD) leads, the sponsor submits a New Drug Submission (NDS) or Abbreviated NDS under the Food and Drug Regulations; the device constituent is addressed as a constituent part. Processing timelines, submission fees, and post-market obligations differ significantly between the two pathways. ### Constituent Part Submissions for the Non-Lead Component Regardless of which directorate leads, Health Canada requires information about both constituent parts of the combination product. The non-lead component is addressed through a Constituent Part submission — a defined set of information provided to the non-lead centre to confirm that the constituent meets applicable standards. For a device-led product, the drug constituent part information typically includes formulation, pharmacological rationale, biocompatibility data, and any interactions between the drug and device materials. For a drug-led product, the device constituent part information includes design specifications, materials, sterilization, and relevant ISO standard compliance. Both directorates must be satisfied before the product may be authorized for sale. ## Regulatory submission process for combination products 01 Characterize the product's primary mode of action by documenting the mechanism through which the intended therapeutic effect is principally achieved. Gather clinical and scientific evidence supporting the PMOA determination. If the PMOA is genuinely ambiguous — the product has substantial physical and pharmacological contributions — prepare a detailed scientific rationale to support a classification ruling request. 02 Submit a classification ruling request to Health Canada if the PMOA is uncertain or contested. Health Canada accepts pre-submission requests to determine which regulatory framework applies. The ruling provides regulatory certainty before investing in full submission preparation. Provide a complete product description, proposed intended use, and the PMOA rationale in the request. 03 Prepare the lead-component regulatory submission. For device-led products: prepare a Class III or IV Medical Device Licence application under the Medical Devices Regulations, including a Summary of Safety and Effectiveness (SOSE) or Device Application Form plus supporting technical documentation. For drug-led products: prepare a New Drug Submission (NDS) meeting the requirements of the Food and Drug Regulations, including preclinical, clinical, and CMC modules. 04 Submit constituent part information for the non-lead component in parallel. Coordinate with the non-lead directorate to understand what information is required. Do not treat the constituent part submission as an afterthought — delays in constituent part review can hold up the overall authorization even when the lead submission is otherwise complete. 05 Maintain post-market obligations for both constituent parts after authorization. Medical Device Licence holders must report mandatory incidents (MDR) and comply with post-market surveillance requirements. Drug Notice of Compliance holders have pharmacovigilance and periodic safety update obligations. Combination products carry dual post-market obligations — establish internal processes that address both sets of requirements. ## Frequently asked questions ### What makes a product a combination product vs a standalone device? A product is a combination product when it combines a drug or biologic with a medical device, and the combined unit is intended as a single integrated or co-packaged presentation for a specific therapeutic or diagnostic purpose. A standalone device that is used alongside a separately purchased drug — where the combination is assembled by the user at the point of care — is typically not a combination product; each component is regulated independently. Integrated products (where the drug is physically incorporated into the device, such as a drug-eluting coating on a stent) are the clearest combination product cases. Co-packaged products (device and drug packaged together for convenience but used as separate items) may or may not be combination products depending on the intended use — seek a Health Canada classification ruling if the categorization is unclear. ### How does Health Canada decide which regulatory framework applies? Health Canada uses the primary mode of action (PMOA) test. The key question is: what is the principal mechanism through which the product achieves its intended therapeutic or diagnostic effect? If the principal mechanism is physical, mechanical, or structural (the device function dominates), the Medical Devices Regulations apply. If the principal mechanism is pharmacological, immunological, or metabolic (the drug function dominates), the Food and Drug Regulations apply. Health Canada's guidance documents on combination products provide worked examples. Where the PMOA genuinely cannot be determined from scientific evidence alone — a rare situation — Health Canada may exercise discretion based on the product most closely related in type, intended use, and safety/effectiveness profile. ### Can CE-marked combination products use EU data for Canadian submissions? Canadian submissions do not recognize CE marking as an authorization equivalent, but data generated for CE marking submissions can be used in Canadian applications. Specifically: ISO 10993 biocompatibility data generated to European standards is accepted for Canadian device constituent part submissions; clinical data from EU clinical investigations is acceptable subject to ICH Good Clinical Practice standards; and EU-format technical documentation (Technical File or Design Dossier) can be adapted for Canadian SOSE requirements. Consult Health Canada's guidance on the use of foreign regulatory information to confirm which data packages from a CE submission are directly usable and where Canadian-specific supplementation is required. ### What is a 'constituent part' submission? A constituent part submission is the information package provided to the non-lead Health Canada directorate covering the component of the combination product that falls under that directorate's jurisdiction. It is not a standalone regulatory submission — it is a defined information set reviewed in conjunction with the lead submission. For a device-led combination product, the drug constituent part package is submitted to the Therapeutic Products Directorate and typically includes: drug formulation data, mechanism of action, pharmacokinetics (if systemic exposure occurs), safety data for the drug in the combined configuration, and interaction studies between the drug and device materials. Health Canada publishes guidance on the content expected for each type of constituent part package. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇨🇦 Canada roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇨🇦 Canada compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $199](/courses/43-canada-health-canada-medical-device-licensing-class-ii-iv)[Prefer to read? Get the book — $24.99](/books/43-canada-health-canada-medical-device-licensing-class-ii-iv) Related guides * [Canada Compliance OverviewComplete guide to Canada product compliance: ISED radio certification, Health Canada devices, CFIA food, and provincial electr…](/guides/canada-compliance-overview) * [Canada Medical Device LicensingHealth Canada's Class I-IV medical device licensing, ISO 13485 requirements, and the public MDALL registry.](/guides/canada-medical-device-licensing) * [US FDA Combination ProductsHow FDA determines the lead review center for drug-device and biologic-device combination products.](/guides/us-combination-products-fda) * [US SaMD: Software as a Medical DeviceWhen software qualifies as a medical device, and the 510(k), De Novo, and PMA pathway decision.](/guides/us-samd-software-medical-device)