Compliance failures can stop market access immediately. In 2024, Health Canada canceled 145 Medical Device Establishment Licences (MDELs) after holders failed to complete the mandatory Annual Licence Review. Once canceled, an establishment can no longer conduct licensable importing or distribution activities, halting revenue and breaking supply commitments overnight. That is precisely why licensing discipline, vigilant regulatory monitoring, and proactive compliance management are critical to uninterrupted market access.
This certified program equips you with the regulatory knowledge and practical decision-making skills to navigate Canada's medical product landscape with authority. You will learn to distinguish decisively between medical devices, drugs, biologics, and natural health products, apply risk-based classification principles, and pinpoint the regulatory requirements attached to each category. The program takes you through Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) requirements, regulatory submissions, and market-authorization pathways, including the fast-moving considerations now governing software and AI-enabled medical devices.
As the program progresses, you will build command of Quality Management Systems (QMS), Good Manufacturing Practices (GMP), and Medical Device Single Audit Program (MDSAP) requirements. You will examine importer and distributor obligations alongside accelerated-access mechanisms, including the Urgent Public Health Need (UPHN) pathway and Special Access Program. Clinical compliance is addressed through Clinical Trial Applications, Investigational Testing Authorizations, and clinical-evidence requirements, and you will master bilingual labeling, promotional compliance, and post-market obligations spanning surveillance, adverse-event reporting, and recalls.
Finally, you will learn how to prepare decisively for Health Canada inspections, respond to regulatory findings, and manage the requirements affecting foreign manufacturers. Practical case studies will sharpen your judgment on product classification, significant changes, and regulatory pathways.
Upon successful completion, you will be awarded the Certification in Health Canada Medical Products Regulations & Compliance, a lifelong credential that proves advanced capability in product classification, market authorization, and lifecycle compliance, and that elevates your professional standing across Canada's regulated medical-products sector.
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This program will entitle you:
Pricing & Registration- Engage in 2 days of expert-led training covering the major Health Canada requirements across medical devices, drugs, biologics, and natural health products, building the regulatory fluency to manage multi-category portfolios and make faster, more consistent market-access and compliance decisions.
- Attain the industry-recognized Certification in Health Canada Medical Products Regulations & Compliance, a lifelong credential proving your ability to interpret classification, licensing, market-authorization, and lifecycle compliance requirements across every Canadian medical product category.
- Strengthen your capability in regulatory submissions, inspection readiness, and post-market vigilance so you identify compliance gaps earlier, respond decisively to regulatory findings, and protect market access throughout the product lifecycle.
- For inquiries, chat with our Program Advisers at [email protected] or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, the body that sets and upholds the governing standards for every professional who completes it.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors, complementing the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice, and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
Health Canada’s medical products regulations rank among the most complex in the world, spanning multiple directorates and over 2,500 pages of legislation, regulations, and guidelines that set exacting requirements for drugs, medical devices, biologics, and clinical trials. Mastering this intricate framework is essential, because Health Canada enforces its compliance standards without leniency, issuing an estimated 1,800 enforcement actions and fines every year against organizations that fall short.
This certified program moves beyond regulatory awareness into the practical controls and decisions that secure compliant market access. You will learn to navigate UPHN and Special Access Program pathways, importer and distributor responsibilities, and QMS, GMP, and MDSAP requirements. These capabilities will equip you to strengthen quality systems and close compliance gaps long before they disrupt market access.
Building on this foundation, you will examine clinical trial application, investigational testing authorization, and clinical-evidence requirements, enabling you to support stronger submissions and better-informed product-development decisions. You will also build real capability in bilingual labeling, promotional compliance, and post-market obligations. Through practical case studies, you will compare classification approaches across Health Canada, FDA, and EU frameworks, assess significant changes affecting higher-risk devices, and prepare decisively for Health Canada inspections. The result: your organization identifies regulatory issues earlier, responds to findings with confidence, and makes faster, more consistent, and more defensible regulatory decisions.
Finally, you will explore how global harmonization and upcoming regulatory changes reshape Canadian market access and broader commercialization strategies. By understanding how Health Canada requirements interact with other regulatory frameworks, you will anticipate change rather than react to it, assess cross-market implications with clarity, and drive more coordinated regulatory planning, strengthening global readiness while raising the consistency and quality of regulatory decision-making across your organization.
Upon successful completion, you will attain the Certification in Health Canada Medical Products Regulations & Compliance. This lifelong credential demonstrates your command of pre-market requirements, market authorization, lifecycle compliance, and post-market vigilance, and positions you as a trusted authority within Canada's regulated medical-products sector.
Key Skills You Will Gain
- Health Canada Regulatory Framework
- Medical Product Category Differentiation
- Risk-Based Product Classification
- Medical Device Class I–IV Assessment
- Cross-Jurisdictional Classification Analysis
- Medical Device Licence (MDL) Requirements
- Medical Device Establishment Licence (MDEL) Requirements
- Licensing Prerequisite Assessment
- Regulatory Submission Strategy
- Regulatory Query Response
- Post-Licence Change Management
- Significant Change Assessment
- Drug & Biologic Regulatory Pathways
- Natural Health Product Compliance
- Market Authorization Strategy
- Software & AI Medical Device Regulation
- Urgent Public Health Need (UPHN) Access
- Special Access Program (SAP) Navigation
- Importer & Distributor Obligations
- Product Recall Management
- Quality Management System (QMS) Application
- Good Manufacturing Practice (GMP) Compliance
- MDSAP Audit Readiness
- Quality-System Documentation
- Clinical Trial Application (CTA) Requirements
- Investigational Testing Authorization (ITA)
- Clinical Evidence Planning
- Bilingual Labeling Compliance
- Promotional Compliance
- Health Canada Inspection & Audit Readiness
Your Faculty Director
Sujata Ghatpande, PMP, PMI-ACP is an accomplished quality and regulatory professional with more than 15 years of medical-device industry experience, specializing in software and AI-enabled medical devices. Her expertise spans regulatory strategy, quality management, product development, and commercialization, guiding startups and fast-growing MedTech companies through Canadian and international requirements. As a consultant and fractional leader, she converts complex regulatory expectations into practical, scalable compliance strategies that clear the path to safe and effective market entry.
Her credentials include hands-on experience with ISO 13485:2016, MDSAP readiness, EU MDR, regulatory clearances, and quality-system audits. Her professional record also includes regulatory consulting on an FDA-cleared Class II AI-enabled radiological device, reinforcing her authority on emerging medical technologies. She gives participants a pragmatic, real-world perspective on regulatory compliance, quality systems, and medical product commercialization.
Health Canada Medical Products Regulations & Compliance Program Agenda
How You Will Benefit
- Navigate Canada's Medical Product Landscape: Understand exactly how devices, drugs, biologics, and natural health products are regulated, so you make stronger regulatory decisions from the outset.
- Make Defensible Product Classification Decisions: Apply risk-based principles to determine product classifications and the precise obligations attached to each class, including software and AI-enabled medical devices.
- Select the Right Regulatory Pathway: Identify the appropriate Canadian authorization route with confidence, based on product category, risk classification, and applicable requirements.
- Navigate MDL and MDEL Requirements: Master licensing prerequisites, processes, and responsibilities so you approach Canadian market access with complete clarity.
- Strengthen Regulatory Submission Capabilities: Prepare and assess submissions with precision and respond to regulatory queries decisively.
- Manage Post-Approval Changes More Effectively: Evaluate how post-licence and significant changes reshape regulatory obligations across the entire product lifecycle.
- Broaden Your Regulatory Expertise: Build working command across pharmaceuticals, biologics, biosimilars, radiopharmaceuticals, and natural health products.
- Understand Accelerated and Special Access Routes: Examine UPHN and Special Access Program pathways and know precisely when they can unlock access.
- Strengthen Quality-System and Inspection Readiness: Apply QMS, GMP, and MDSAP principles while preparing decisively for audits, inspections, and regulatory findings.
- Protect Long-Term Market Access: Identify compliance gaps earlier, strengthen post-market controls, and drive more consistent lifecycle compliance decisions.
Certification in Health Canada Medical Products Regulations & Compliance
Upon successful completion of this program, you will be awarded the Certification in Health Canada Medical Products Regulations & Compliance, a lifelong credential you can carry on your resume, CV, and professional profile to demonstrate advanced capability in Canadian medical product regulation.
This certification proves your command of Canadian medical product regulations, regulatory submissions, and compliance management. Developed by the Chartered Institute of Professional Certifications, the program content has been independently accredited by CPD Certification Service as conforming to Continuing Professional Development principles.
Pricing & Registration
Canada
Dates: 01 - 02 Apr 2027
Venue: Online Executive Program (via Zoom)
Time: 8:00am - 3:30pm Pacific Time (PT)
10:00am - 5:30pm Central Daylight Time (CDT)
11:00am - 6:30pm Eastern Daylight Time (EDT)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 22 Jan 2027 | By 05 Mar 2027 | After 05 Mar 2027 | |
| Canada Delegates | CAD 1,895 | CAD 2,195 | CAD 2,295 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. For any inquiries about this program, please contact our Program Advisor at [email protected] or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
Securing your manager's approval to attend can be difficult if you do not know what to say – so we have prepared the template for you. Simply download it, copy and paste it into an email, and send it to your boss!
Health Canada Medical Products Regulations & Compliance
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