The ultimate guide to obtaining a Medical Device Establishment Licence

The ultimate guide to obtaining a Medical Device Establishment Licence

The Ultimate Guide to Obtaining a Medical Device Establishment Licence

 

If you are planning to, import, distribute, or sell medical devices in Canada or manufacture Class I medical devices in Canada, you must have a Medical Device Establishment Licence. This guide will explain what the requirements are and how to obtain this license so that you can begin your business activities.

What is a Medical Device Establishment Licence?

A Medical Device Establishment Licence is required by regulation for companies that import, distribute, or sell medical devices in Canada. The license regulates such activities to ensure products are safe and suitable for their intended use. It also ensures the effective traceability of the device when it is distributed and sold.

Who needs to obtain an MDEL License?

All businesses in Canada that import, distribute, or sell medical* devices must obtain a Medical Device Establishment Licence (MDEL) before they are allowed to operate. Manufacturers of Class I devices are also required to obtain an MDEL unless the devices are shipped directly to the ultimate consumer, or the importer/distributor has an MDEL.  Those required to obtain the licence must do so from Health Canada, after receiving all documentation needed for the application process.

How to Apply for a Health Canada MDEL?

The application process for a Health Canada MDEL requires applicants to provide several documents, such as the establishment license application form, the prescribed document checklist, and Standard Operating Procedures.  It is a good business practice to use a business registered with the Canadian ULC or equivalent provincial jurisdiction With all paperwork in place and the accompanying fees, applications may be submitted to Health Canada via mail or email.

How to manage Your MDEL Licence once you have It?

Once you have an MDEL Licence, it is important to keep a close eye on the rules and regulations related to operating with a medical device establishment license. All establishments must maintain records of activities such as distribution records, complaint handling, and recalls r. The products made or sold by the company should comply with Health Canada requirements and be regularly inspected to ensure their safety and effectiveness. Moreover, the licensee must report any changes made within their establishment that could have an impact on product quality or integrity.

What are the Medical Device Establishment Licence regulatory requirements in Canada?

To obtain and maintain a Medical Device Establishment Licence in Canada, the licensee needs to adhere to the Medical Devices Regulations and other applicable guidelines. Moreover, establishments must have. The licensee should also get product liability insurance coverage when filing for licensure though it’s not a requirement. All documents related to the establishment as well as materials substantiating compliance must be made available upon request.

Who are the regulatory bodies for Medical Devices?

The regulation of medical devices in Canada is the responsibility of Health Canada. Health Canada is the national regulatory body responsible for ensuring that medical devices sold in Canada are safe and effective. Health Canada regulates medical devices through the Medical Devices Regulations, part of the Food and Drugs Act.

The Medical Devices Regulations are designed to ensure that medical devices are safe and effective for their intended use. The regulations cover all aspects of the medical device industry, from manufacturing to distribution to sales. The rules also require that medical devices be classified according to risk level, with higher-risk devices requiring more stringent regulatory requirements.

The Medical Devices Regulations are enforced through the Medical Devices Bureau (MDB) of Health Canada. The MDB is responsible for assessing the safety and effectiveness of medical devices and ensuring that they meet all regulatory requirements. The MDB also provides guidance and support to companies that are seeking to obtain an MDEL.

What are the types of Medical Device Establishment Licenses?

Health Canada can issue two types of Medical Device Establishment Licenses (MDEL). The first type is a Class I MDEL, given to companies that import, distribute, or sell low-risk medical devices. The second type is a Class II to IV MDEL, issued to companies that import, distribute, or sell medium to high-risk medical devices.

The classification of medical devices is based on their level of risk. Medium to high-risk devices, such as pacemakers and artificial joints, are classified as Class II to IV devices. Low-risk devices, such as bandages and tongue depressors, are classified as Class I devices.

The classification of a medical device determines the regulatory requirements that must be met before it can be sold in Canada. Higher-risk devices require more stringent regulatory requirements, including clinical trials and pre-market reviews. Lower-risk devices may only require product labeling and advertising review.

What are the steps to obtaining a Medical Device Establishment License?

Obtaining a Medical Device Establishment License (MDEL) can be complex and challenging. However, by following these steps, you can ensure your application succeeds.

Step 1: Determine if you need an MDEL
The first step in obtaining an MDEL is determining if you need one. If you are a company that imports, distributes, or sells medical devices in Canada, you will need an MDEL. If you are still determining whether you need an MDEL, contact Health Canada for guidance.

Step 2: Classify your medical device
The second step in obtaining an MDEL is to classify your medical device. This will determine the regulatory requirements that must be met before your device can be sold in Canada.

Step 3: Prepare your application
The third step in obtaining an MDEL is to prepare your application. This will involve gathering all necessary documentation and completing the application form.

Step 4: Submit your application
The fourth step in obtaining an MDEL is to submit your application to Health Canada. You will need to pay an application fee at this time.

Step 5: Wait for the review
The fifth step in obtaining an MDEL is to wait for your application to be reviewed by Health Canada. This process can take several months.

Step 6: Obtain your MDEL
The final step in obtaining an MDEL is receiving your Health Canada license. Once you have your MDEL, you can legally import, distribute, or sell medical devices in Canada.
Documentation Required for Medical Device Establishment License
When applying for a Medical Device Establishment License (MDEL), you must provide various documentation to Health Canada. The accurate documentation required will depend on the classification of your medical device but may include the following:
– Device specifications and drawings
– Manufacturing process documentation
– Risk analysis and hazard identification
– Quality system documentation
– Clinical trial data (if applicable)
– Advertising and labeling materials
– Importation and distribution records
It is crucial to ensure that all documentation is accurate and complete. Only complete or precise documentation can prevent delays in the application process.

How to register your medical device establishment in Canada?

Registering a medical device establishment in Canada involves several steps to ensure compliance with Health Canada’s regulations.
 
  1. Determine Device Classification: Identify the classification of your medical device according to Health Canada’s risk-based classification system. Medical devices are classified into Classes I to IV, with Class I being low risk and Class IV being high risk.

  2. Appoint an Authorized Regulatory Representative (ARR): If your establishment is located outside of Canada, you may need to appoint an Authorized Regulatory Representative (ARR) who is a Canadian citizen or a Canadian company. The ARR will act as a liaison between your establishment and Health Canada.

  3. Prepare Application Package: Compile the required documentation and information for your establishment registration application. This typically includes:

    • Company information: Name, address, contact details, etc.
    • Device information: Types, classifications, intended uses, etc.
    • Manufacturing and quality control processes: Details about how the devices are manufactured, controlled, and tested.
    • List of devices: Provide a list of all the medical devices manufactured, imported, distributed, or sold by your establishment.
  4. Submit Application: Submit your establishment registration application to Health Canada’s Medical Devices Directorate (MDD) through the appropriate channels. Health Canada offers an online platform for submitting applications.

  5. Pay Fees: Pay the required establishment registration fees. Fees vary based on the classification of your medical devices and the size of your establishment.

  6. Review and Approval: Health Canada will review your application and assess the information provided. If your application meets the requirements, you will receive an Establishment Licence, which allows you to conduct certain activities related to medical devices in Canada.

  7. Maintain Compliance: Once your establishment is registered, you are required to maintain compliance with Health Canada’s regulations. This includes adhering to Good Manufacturing Practices (GMP) and quality control standards.

  8. Notification of Changes: Inform Health Canada of any changes to your establishment’s information, such as changes in address, authorized representative, or significant changes to the medical devices you manufacture or distribute.

  9. Device Licensing: Keep in mind that the registration of your establishment does not automatically authorize the sale of your medical devices in Canada. Each individual medical device may require its own Medical Device Licence, which involves a separate application process.

Tips for a Successful Application Process

Obtaining a Medical Device Establishment License (MDEL) can be complex and challenging. However, by following these tips, companies can increase their chances of success:
– Understand the regulatory requirements for your medical device
– Develop a comprehensive quality system that meets all regulatory requirements
– Ensure that all documentation is accurate and complete
– Seek guidance and support from Health Canada when needed
– Be prepared for a lengthy and complex application process
– Allocate resources for regulatory compliance
– Budget for the high cost of obtaining an MDEL

1. Thoroughly Understand the Requirements: Familiarize yourself with the requirements outlined by Health Canada for obtaining an MDEL. Ensure that you clearly understand the necessary documentation, quality management system requirements, and any specific requirements based on the classification of your devices.
2. Prepare a Comprehensive Application: Take the time to gather all the necessary documentation and information required for the MDEL application. Ensure the application is complete and accurate, providing all the required details. All information must be present to avoid delays or rejection of the application.
3. Seek Guidance from Regulatory Experts: If you are new to the Canadian market or unfamiliar with the MDEL application process, consider seeking guidance from regulatory experts or consultants. They can provide valuable insights and advice to navigate the complexities of the application process and ensure compliance with regulatory requirements.
4. Establish a Robust Quality Management System: Invest time and resources in developing a comprehensive quality management system that meets the necessary standards outlined by Health Canada. Implement procedures for documenting, implementing, and maintaining the quality management system, ensuring it is aligned with internationally recognized standards.
5. Document Control and Record Keeping: Establish a robust document control and record-keeping system. Ensure that all documentation related to the MDEL application, including the Device Master File, quality management system procedures, and inspection records, are readily available and up to date.
6. Be Proactive and responsive: Respond promptly and thoroughly to any requests for clarification or additional information from Health Canada. Address any gaps or deficiencies identified during the application review or inspection process.
7. Stay Informed: Keep up with the latest regulatory updates and changes. Health Canada periodically updates its regulations and requirements, and it is important to stay informed to ensure ongoing compliance with the MDEL regulations.

Also, budgeting for the high cost of obtaining an MDEL is essential when planning to bring a medical device to the Canadian market.

 

What are the requirements for obtaining an MDEL?

1. Establishment Information: You must provide detailed information about your establishment, including its legal name, address, contact information, and type of business entity (e.g., corporation, partnership, sole proprietorship). It is important to ensure this information is accurate and up-to-date, as any changes must be promptly reported to Health Canada.
2. Quality Management System: Your establishment must have a robust quality management system (QMS). The QMS should encompass all aspects of your establishment’s operations, including the production, distribution, storage, and servicing of medical devices. It should be based on internationally recognized standards, such as ISO 13485, and include procedures for documenting, implementing, and maintaining the QMS.
3. Person Responsible for Regulatory Compliance (PRRC): You must designate a qualified individual within your establishment responsible for ensuring regulatory compliance. This person should have the knowledge, experience, and authority to oversee the establishment’s compliance with the MDEL requirements. They should also be familiar with the applicable regulations and standards governing medical devices in Canada.
4. Site Licensing: If your establishment has multiple locations, each must obtain its Site License. The Site License ensures that each location meets the necessary standards for safety and quality. The application for a Site License includes information about the physical layout of the establishment, storage facilities, and quality control procedures specific to each location.
5. Product Classification: You must determine the classification of your medical devices according to the risk they pose to patients and users. Health Canada has established four classes of medical devices (Class I, II, III, and IV), with Class IV devices posing the highest risk. The classification of your devices will determine the level of scrutiny and the documentation requirements for obtaining an MDEL.
6. Device Master File: For Class II, III, and IV devices, you must prepare a Device Master File (DMF) that provides detailed information about your devices’ design, manufacture, and performance characteristics. The DMF serves as a comprehensive reference document for Health Canada to assess the safety and effectiveness of your devices.
7. Good Manufacturing Practices (GMP): If your establishment manufactures medical devices, you must comply with Good Manufacturing Practices (GMP). GMP ensures that your manufacturing processes are consistent, controlled, and meet the necessary standards for safety and quality. Compliance with GMP is assessed through inspections conducted by Health Canada.

These are the key requirements for obtaining an MDEL. It is important to note that the specific requirements may vary depending on the type of medical devices your establishment is involved with. Now that we have discussed the requirements let’s move on to the application process for obtaining an MDEL.

What are the steps to apply for an MDEL?

1. Preparation: Before initiating the MDEL application process, gathering all the necessary documentation and information is crucial. This includes establishing a robust quality management system, preparing the Device Master File (if applicable), and ensuring that your establishment meets the requirements outlined by Health Canada.
2. Online Application: The MDEL application process is conducted through Health Canada’s online portal. You must create an account and complete the online application form, providing all the required information and documentation. It is important to ensure that the information provided is accurate and up to date, as any discrepancies can result in delays or rejection of the application.
3. Application Review: Once your application is submitted, Health Canada will review the provided information and documentation to assess your establishment’s compliance with the MDEL requirements. This review process may involve additional requests for clarification or other documentation. It is important to respond promptly and thoroughly to these requests to avoid delays in the application process.
4. Inspection: In some cases, Health Canada may inspect your establishment to assess its compliance with the MDEL requirements. The inspection may include reviewing your quality management system, site facilities, and documentation on the imported, distributed, or sold medical devices. It is important to be prepared for the inspection and ensure all required documentation is readily available.
5. Approval and Issuance: Once Health Canada satisfies your establishment’s MDEL requirements, they will issue the MDEL. The MDEL will specify the activities your establishment is authorized to perform and any conditions or restrictions that may apply. Reviewing the MDEL carefully and ensuring you understand and comply with all the requirements outlined is important.

The application process for obtaining an MDEL can be complex and time-consuming. However, with proper preparation, attention to detail, and adherence to regulatory requirements, you can increase your chances of a successful application. Let’s explore some common challenges and obstacles that manufacturers may encounter during the MDEL application process.

What are the common challenges and obstacles to obtaining an MDEL?

1. Lack of Documentation: One of the common challenges manufacturers face is needing more documentation or complete documentation. It is important to ensure that all required documentation, such as the Device Master File and quality management system procedures, are full and readily available. With proper documentation, your application may be completed on time.
2. Inadequate Quality Management System: A robust quality management system is a key requirement for obtaining an MDEL. Manufacturers may need help establishing and implementing a comprehensive quality management system that meets the necessary standards. It is important to invest time and resources in developing a robust quality management system that aligns with the requirements outlined by Health Canada.
3. Understanding Regulatory Requirements: Navigating the regulatory landscape can be overwhelming, especially for manufacturers new to the Canadian market. Understanding the specific requirements for obtaining an MDEL and ensuring compliance with the applicable regulations and standards can be challenging. Seeking guidance from regulatory experts or consultants can help manufacturers navigate the complexities of the MDEL application process.
4. Inspection Readiness: Manufacturers may need help in preparing for inspections conducted by Health Canada. Ensuring that all documentation and facilities comply with the MDEL requirements is important. Internal audits and mock inspections can help manufacturers identify and address gaps or deficiencies before the actual inspection takes place.
5. Timelines and Delays: The MDEL application process can be time-consuming, with the review and approval process taking several months. Manufacturers may face challenges in managing timelines and dealing with potential delays. It is important to plan and allocate sufficient time for the application process, including gathering the necessary documentation, responding to requests for clarification, and preparing for inspections.

What is the medical device licensing process in Canada?

Here is a general overview of the medical device licensing process:

  1. Determine Device Classification: Classify your medical device according to Health Canada’s risk-based classification system. The classification will determine the level of regulatory scrutiny your device will undergo.

  2. Prepare a Medical Device Licence Application: Prepare a comprehensive application package that includes detailed information about your medical device, its intended use, design, manufacturing processes, labeling, and any clinical data or evidence of safety and effectiveness.

  3. Quality Management System (QMS): If applicable, ensure that your manufacturing processes adhere to Good Manufacturing Practices (GMP) and maintain a Quality Management System (QMS) that meets regulatory requirements.

  4. Submit Application: Submit your Medical Device Licence application to Health Canada through the appropriate channels. Health Canada provides an online platform for submitting applications.

  5. Pay Fees: Pay the required fees associated with the Medical Device Licence application. Fees vary based on the classification and risk level of the device.

  6. Pre-Market Review: Health Canada will review your application to assess the safety, efficacy, and quality of your medical device. The level of review varies based on the device classification. Class I devices generally undergo a less rigorous review, while higher-risk devices (Class III and IV) may require more extensive evaluation, including clinical data.

  7. Review and Evaluation: Health Canada’s review may include an assessment of the device’s design, manufacturing processes, labeling, and clinical data (if applicable). They will also consider risk management and post-market surveillance plans.

  8. Obtain a Medical Device Licence: If your application is successful and your device meets all regulatory requirements, you will receive a Medical Device Licence, allowing you to market and distribute the device in Canada.

  9. Post-Market Obligations: Once your device is licensed, you have ongoing obligations to ensure its continued safety and effectiveness. This includes monitoring adverse events, conducting post-market surveillance, and reporting any changes or updates to Health Canada.

  10. Labeling and Advertising: Ensure that your device’s labeling and advertising are accurate, clear, and compliant with Health Canada’s regulations.

  11. Renewal and Maintenance: Medical Device licenses typically require renewal every year or every few years, depending on the device classification. Make sure to maintain compliance with Health Canada’s regulations to ensure timely renewals.

*We work closely with Health Canada and follow their guidance throughout the medical device licensing process.*

What are the differences between MDEL and other regulatory approvals?

Health Canada’s MDEL is specific to the establishment involved in importing, distributing, or selling medical devices. Understanding the key differences between the MDEL and other regulatory approvals is important to ensure compliance with the applicable requirements.

1. MDEL vs. Medical Device License (MDL): The MDEL is specific to the establishment, while the Medical Device License (MDL) is specific to the medical device itself. The MDL is required for Class II, III, and IV medical devices and is obtained through a separate application process. The MDL demonstrates that the specific medical device meets safety and effectiveness requirements.
2. MDEL vs. ISO Certification: ISO certification, such as ISO 13485, is a voluntary certification that demonstrates compliance with internationally recognized quality management system standards. While ISO certification is not a requirement for obtaining an MDEL, it can be beneficial in demonstrating your establishment’s commitment to quality and compliance.

Conclusion

Obtaining a Medical Device Establishment License (MDEL) is critical to bringing a medical device to the Canadian market. It ensures that only safe and effective medical devices are available to the Canadian public and provides a regulatory framework for companies to follow.

While obtaining an MDEL can be a complex and challenging process, companies can increase their chances of success by following the steps outlined in this guide and seeking guidance and support from Health Canada. By understanding the regulatory requirements, developing a comprehensive quality system, and ensuring that all documentation is accurate and complete, companies can successfully obtain their MDEL and bring their medical device to the Canadian market.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: 

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