Health Canada Regulatory Affairs Flashcards
What is Health Canada’s role in medical device regulation?
Health Canada is the federal department responsible for regulating medical devices in Canada. Through the Therapeutic Products Directorate (TPD) and its Medical Devices Bureau, Health Canada evaluates and monitors the safety, effectiveness, and quality of diagnostic and therapeutic medical devices.
What legislative framework governs medical devices in Canada?
In Canada, medical devices are regulated under the Food and Drugs Act and the Medical Devices Regulations (SOR/98-282). These establish the requirements for the sale, importation, and advertisement of medical devices in Canada, including classification, licensing, quality management systems, labeling, and post-market surveillance.
What is a Medical Device License (MDL) in Canada?
A Medical Device License (MDL) is a license issued by Health Canada that permits the sale or importation of Class II, III, and IV medical devices in Canada. The license is issued to the manufacturer or regulatory representative after review of the application and determination that the device meets applicable safety and effectiveness requirements.
What are the medical device risk classifications in Canada?
Canada classifies medical devices into four classes based on risk level:
- Class I: Lowest risk (e.g., bandages, non-invasive instruments)
- Class II: Low to moderate risk (e.g., infusion pumps, contact lenses)
- Class III: Moderate to high risk (e.g., pacemakers, breast implants)
- Class IV: Highest risk (e.g., heart valves, implantable defibrillators)
Classification is determined using classification rules in the Medical Devices Regulations.
What is an MDEL and who requires one?
A Medical Device Establishment License (MDEL) is required for companies that import or sell medical devices in Canada but do not manufacture them. This includes importers, distributors, and certain retailers. An MDEL holder must maintain distribution records, have procedures for complaint handling and recalls, and comply with problem reporting requirements.
How is ISO 13485 used in Canadian medical device regulation?
In Canada, ISO 13485 certification is mandatory for manufacturers of Class II, III, and IV medical devices. The Canadian version, CAN/CSA-ISO 13485, includes specific Canadian requirements. A quality management system certificate issued by a recognized registrar (CMDCAS or MDSAP) must be included with license applications for these device classes.
What is MDSAP and why is it important for the Canadian market?
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit by an authorized Auditing Organization to satisfy quality system requirements of multiple regulatory authorities, including Health Canada. Since January 2019, MDSAP certification has been mandatory for all medical device manufacturers selling in Canada (Classes II-IV).
What constitutes a “Significant Change” requiring notification to Health Canada?
A Significant Change is a change that could reasonably be expected to affect the safety or effectiveness of a licensed medical device. This includes changes to design, manufacturing processes, intended use, safety/performance specifications, or labeling. Significant changes must be reported to Health Canada, and may require a license amendment before implementation.
What is a Medical Device Incident Report (MIR) in Canada?
A Medical Device Incident Report (MIR) is a report made to Health Canada when an incident involving a medical device meets mandatory reporting criteria. Manufacturers and importers must report incidents that relate to a failure, deterioration, or inadequacy in a device’s design or manufacture that has led to death or serious deterioration in health of a patient, user, or other person.
What is a Foreign Risk Notification in Canadian medical device regulation?
A Foreign Risk Notification is a report that manufacturers or importers must submit to Health Canada when they become aware of a risk communicated or action taken by a foreign regulatory agency, manufacturer, or importer related to a serious risk of injury to human health associated with the use of a medical device marketed in Canada.
For which of the following device classes is a Medical Device License NOT required in Canada?
A) Class I
B) Class II
C) Class III
D) Class IV
A) Class I
Class I devices are exempt from device licensing requirements, though manufacturers still must meet regulatory requirements for distribution records, complaint handling, and problem reporting. An MDEL may be required for importers and distributors.
As of 2024, which device class has the highest Medical Device License application fee in Canada?
A) Class I
B) Class II
C) Class III
D) Class IV
D) Class IV
Class IV devices have the highest application fee ($28,165 CAD), followed by Class III ($12,987 CAD) and Class II ($615 CAD). Class I devices do not require a license and therefore have no license application fee.
For clinical investigations of medical devices in Canada, which standard is more directly applicable?
A) 21 CFR Part 812
B) ISO 14155
C) ICH-GCP
D) ISO 9001
B) ISO 14155
ISO 14155 is an international standard for clinical investigations of medical devices that is recognized internationally and aligns with Health Canada’s expectations. 21 CFR Part 812 is specific to the U.S. FDA regulation of clinical investigations.
In Canada, the responsibility for initiating a recall of a medical device primarily rests with:
A) Health Canada
B) The manufacturer
C) The importer
D) The MDSAP auditing organization
B) The manufacturer
In Canada, the responsibility for initiating a recall rests primarily with the manufacturer, although Health Canada has the authority to request or, in rare instances, mandate a recall if the manufacturer fails to act appropriately in response to a safety issue.
Outline the process for obtaining a Medical Device License in Canada.
- Determine device classification (Class I-IV)
- For Class II, III, IV devices:
- Obtain MDSAP certification or equivalent Quality Management System recognition
- Prepare technical documentation appropriate to device class
- Complete application forms and prepare fee payment
- Submit application through Health Canada’s online system
- For Class III and IV:
- Undergo more extensive review of safety and effectiveness data
- Respond to deficiency letters if issued
- Receive Medical Device License if application is approved
- Maintain compliance with post-market requirements
What is the process for mandatory incident reporting to Health Canada?
- Identify reportable incident: death, serious deterioration in health, or potential for such if recurrence
- Preliminary investigation of incident
- Submit preliminary report to Health Canada:
- Within 10 days for death or serious deterioration in health
- Within 30 days for near incidents that could lead to death/serious deterioration
- Conduct full investigation
- Submit final report:
- Within 30 days for death or serious deterioration
- Within 60 days for near incidents
- Implement corrective actions if necessary
- Report corrective actions to Health Canada
A US-based company wishes to market their AI-based diagnostic software in Canada. What should they consider from a regulatory perspective?
- Determine appropriate device classification (likely Class II or higher)
- Obtain MDSAP certification covering Canada
- Address Canadian-specific requirements:
- Bilingual labeling (English and French)
- Compliance with Canadian privacy laws for healthcare information
- Prepare technical documentation including:
- Software validation data
- Clinical evidence supporting Canadian intended use
- Risk management file addressing Canadian context of use
- Submit Medical Device License application with appropriate fees
- Establish Canadian vigilance system for adverse event reporting
- Consider if a Canadian importer or distributor with MDEL is needed
A manufacturer has developed a drug-eluting stent and wants to market it in Canada. What regulatory pathway should they follow?
- Determine the primary mechanism of action to identify lead review bureau
- For drug-eluting stents, usually regulated as medical devices (Class IV)
- Require both:
- Medical Device License (MDL) for the device component
- Assessment of the drug substance through consultation with Biologics and Genetic Therapies Directorate
- Submit comprehensive technical documentation addressing:
- Device safety and performance
- Drug safety, efficacy, and quality
- Interaction between drug and device components
- MDSAP certification covering combination product manufacturing
- Develop specific post-market surveillance plan addressing both components
- Consider parallel submissions with other markets (US, EU) to streamline global strategy
What is the Special Access Programme (SAP) for medical devices in Canada?
The Special Access Programme for medical devices allows healthcare professionals to request access to unlicensed medical devices for emergency use or when conventional therapies have failed, are unavailable, or unsuitable. Strategic considerations include:
- Only for patients with serious or life-threatening conditions
- Case-by-case authorization by Health Canada
- Cannot be used to circumvent regular licensing requirements
- Manufacturers must have adequate evidence of safety and effectiveness
- Not intended for long-term access or routine use
What is a Canadian Reference Product and how is it used in medical device regulation?
A Canadian Reference Product is a medical device that has been licensed and marketed in Canada that serves as a comparator for a new device seeking approval. Strategic use includes:
- Demonstrating substantial equivalence similar to US 510(k) approach
- Supporting safety and effectiveness claims through comparative data
- Reducing clinical data requirements when appropriate
- Establishing acceptable performance standards in the Canadian market
- Providing benchmarks for testing protocols and acceptance criteria
What is the Fees for Drugs and Medical Device Regulations in Canada and how can they affect regulatory strategy?
The Fees for Drugs and Medical Device Regulations establish the fee structure for regulatory activities in Canada, including:
- Application fees for licensing (varying by device class)
- Annual license maintenance fees
- Right to sell fees for Medical Device Establishment Licenses (MDELs)
Strategic considerations include:
- Small business fee reductions (potential 50% reduction)
- Fee mitigation through timing of submissions
- Budget planning for regulatory maintenance costs
- Understanding fee waivers for specific circumstances (public health emergencies)
- Aligning submission timing with fiscal planning
What is the System of Expedited Registration (SER) for Healthy Food Products Sold in Medical Devices in Canada?
The System of Expedited Registration (SER) is a special pathway for medical devices containing food products with health claims. Key strategic considerations include:
- Applies to combination products where a food component with a health claim is part of a medical device
- Requires coordination between the Natural and Non-prescription Health Products Directorate and Medical Devices Bureau
- Enables streamlined review when both food health claims and device functions are present
- May accelerate time to market for certain nutrition-related therapeutic technologies
- Requires compliance with both food and device regulations
Which factor would most significantly influence the strategic decision to use a Canadian Medical Device License Reference for a new device application?
A) The reference device has the same manufacturer as the new device
B) The reference device has an identical intended use and similar technological characteristics
C) The reference device has been recalled for safety reasons
D) The reference device has been on the Canadian market for over 10 years
B) The reference device has an identical intended use and similar technological characteristics
Similar to the US 510(k) process, substantial equivalence depends primarily on showing that the new device has the same intended use and similar technological characteristics as the reference device, with no new safety or effectiveness questions.
Which market entry strategy would typically be most efficient for a medical device already approved in the US and EU seeking Canadian market access?
A) Submit a new application with full technical documentation
B) Request expedited review based on prior approvals
C) Use foreign approvals to reduce testing requirements while following standard application procedures
D) Apply through the Special Access Programme first
C) Use foreign approvals to reduce testing requirements while following standard application procedures
Health Canada recognizes prior approvals and may accept certain testing data and reviews from trusted regulatory authorities, but still requires a standard application. There is no formal expedited pathway simply based on foreign approvals, and the SAP is not intended for routine market entry.
When developing a Health Canada regulatory strategy for a combination product with both drug and device components, which factor is most critical to determine first?
A) The primary mode of action
B) The device classification
C) Whether the drug component is already approved in Canada
D) Manufacturing location
A) The primary mode of action
The primary mode of action determines which regulatory pathway and which bureau within Health Canada will take the lead in the review process. This fundamental determination drives all subsequent regulatory requirements and submission strategies.
Outline a strategy for addressing bilingual labeling requirements in Canada
Effective bilingual labeling strategy for Canada includes:
1. Early integration of translation requirements into label development timeline
2. Engagement of professional translators familiar with medical terminology in Canadian French
3. Implementation of a verification process by native French speakers to ensure accuracy
4. Space allocation planning in label design to accommodate both languages
5. Development of a master glossary of terms for consistency across product lines
6. Review against Health Canada guidance documents for specific bilingual requirements
7. Consideration of Quebec-specific language requirements which may exceed federal standards
8. Implementation of version control system that manages both language versions simultaneously
Describe a strategic approach to managing the transition from CMDCAS to MDSAP certification
Strategic MDSAP transition management includes:
1. Early engagement with an MDSAP-recognized Auditing Organization
2. Gap assessment between current QMS and MDSAP requirements
3. Development of a transition timeline with buffer for unexpected issues
4. Prioritization of critical findings from gap assessment
5. Implementation of missing MDSAP-specific processes (e.g., enhanced data analysis)
6. Training of key personnel on MDSAP model and requirements
7. Conducting mock audits using MDSAP audit model
8. Planning for resource availability during intensive initial MDSAP audit
9. Development of communication plan to explain new certification to stakeholders
10. Consideration of multi-market strategy to maximize benefits of MDSAP’s multi-jurisdiction recognition
