Medical device meetings draft guidance document: Guidance for implementation

On this page

• Operating principles
• Meeting types and their eligibility criteria
• Combination products
• How to request a meeting
• Meeting package
• Where to file the request for a meeting

Operating principles

1. Health Canada will determine whether a meeting is warranted based on the information submitted by the requestor and will inform the requestor accordingly.
2. Questions asked by the requestor that can only be answered following the completion of a formal review of all relevant information and evidence will not be addressed during the meeting.
3. Health Canada will provide non-binding advice and guidance to requestors based on current regulations, policies, guidance documents and experience. However, having a meeting with Health Canada does not guarantee issuance of a licence or an authorization for the devices discussed.
4. Meetings will generally be 1 hour in length, typically with a maximum 20-minute presentation by the requestor followed by a discussion.
5. Health Canada, in consultation with the requestor, will make the final determination on the number and role of attendees, as well as the format of the meeting (teleconference or face to face).
6. Health Canada may consult or invite other relevant internal Health Canada divisions to participate, as necessary. This includes Marketed Health Products Directorate (MHPD), Regulatory Operations and Enforcement Branch (ROEB) and Healthy Environments and Consumer Safety Branch (HECSB).
7. Health Canada may consult or invite other government departments to participate, as necessary. This includes Innovation, Science and Economic Development Canada (ISED) and the Canadian Nuclear Safety Commission (CNSC).

Meeting types and their eligibility criteria

MDD offers 3 types of meetings:

• innovation information meetings
• pre-clinical meetings
• pre-submission meetings

Requesting a meeting with Health Canada is voluntary for requestors.

This section details the purpose of each meeting type and suggested eligibility criteria for requesting a meeting with MDD. The eligibility criteria listed are not an exhaustive list. The Directorate understands there are situations where a meeting may be warranted outside of this list, and those situations shall be considered on a case-by-case basis.

If the product is not eligible for a meeting described in this guidance document, Health Canada may still provide advice and guidance. Please send questions via email to MDD enquires: hc.meddevices-instrumentsmed.sc@canada.ca.

Innovation information meetings

Innovation information meetings provide a forum for Health Canada to engage with manufacturers of innovative medical devices well in advance of the submission of a formal regulatory application. They provide an opportunity for Health Canada to learn about upcoming medical technologies, and forecast future resource and expertise requirements. An innovation information meeting takes place earlier in the development cycle than a pre-clinical meeting or a pre-submission meeting.

During an innovation information meeting, Health Canada will invite manufacturers to share information related to their innovative medical device, without the expectation of receiving detailed technical feedback. Regulatory issues such as product categorization (for example, drug, device, natural health product, etc.), or device classification (Class I - IV) may be considered during this type of meeting.

While Health Canada may ask clarifying questions during an innovation information meeting, these meetings will generally serve as a platform for Health Canada to listen and learn.

This type of meeting could also be beneficial in instances where:

• the device is novel (for example, is not characterized or coded within the Global Medical Devices Nomenclature (GMDN) database)
• the device introduces novel manufacturing technologies, processes or challenges
• the technology already exists but there is a novel intended use being proposed
• the technology has the potential to be a disruptive technology, that is:
  • an innovation that fundamentally transforms the health care delivery system, provides a new solution with a medical device that challenges existing paradigms and revolutionizes the way treatments are administered
• the product cannot be easily categorized (for example, drug, device, natural health product, etc.) or does not directly meet a definition in the Regulations under the Food and Drugs Act
• the product is a combination product, where the lead Review Bureau has not been previously determined

Pre-clinical meetings

Pre-clinical meetings are held prior to filing an ITA application to Health Canada. They provide an opportunity for requestors to highlight specific concerns or uncertainty regarding the design of the clinical investigation protocol or the evidence supporting the transition into the clinical investigation phase of device development. They also give Health Canada an opportunity to provide guidance and highlight potential deficiencies or areas of concern (for example, unclear evidence) with respect to the proposed investigation. These meetings also aim to reduce requests for additional information during the application review process. Advice received at these meetings may influence the requestor's design of the investigational testing protocol. The requestor may invite qualified investigators who will be involved in the proposed investigation in Canada to attend the meeting.

Pre-clinical meetings allow requestors to discuss issues associated with gaps and/or ambiguities in established regulations, guidance documents, standards, testing limitations (ethical, logistical, etc.) or accepted research practices where information is not readily or clearly available to stakeholders.

Health Canada will not evaluate data and will not assess the acceptability of this data to demonstrate the safety and effectiveness of a medical device. This type of meeting could be beneficial in instances where:

• the technology already exists but there is a novel intended use being proposed
• the technology has the potential to be a disruptive technology and it would be helpful to familiarize Health Canada with this new technology prior to submitting an application
• testing of the medical device is associated with a novel or complex statistical approach or an unrecognized standard

Pre-submission meetings

Pre-submission meetings provide the requestor with an opportunity to present relevant data and discuss concerns, issues and uncertainties regarding the information and evidence they intend to use to support a medical device licence application. They allow requestors to inquire about complex regulatory questions where information is not readily or clearly available in existing policies, guidance documents or regulations. They also give Health Canada an opportunity to provide guidance and highlight potential deficiencies or concerns regarding the proposed submission strategy. This meeting process should be used when the requestor believes that certain information and evidence could be perceived differently than intended and where there may be a need to clarify expectations pertaining to the presentation of data and evidence. The goal of these meetings is to improve the quality of the forthcoming application and to allow the requestor and Health Canada to reach consensus on how to present evidence within a licence application to reduce the requests for additional information during the application review process. The requestor may invite qualified investigators or medical experts to attend the meeting.

Health Canada will not evaluate data and will not assess the acceptability of this data to demonstrate the safety and effectiveness of a medical device. This type of meeting could also be beneficial in instances where:

• the technology exists but there is a novel intended use being proposed
• the technology has the potential to be a disruptive technology and it would be helpful to familiarize Health Canada team with this new technology prior to submitting an application
• testing of the medical device is associated with a novel or complex statistical approach or an unrecognized standard

Combination products

A combination product will be subject to either the Medical Devices Regulations (MDR) or the Food and Drugs Regulations (FDR) according to the principal mechanism of action by which the claimed effect or purpose is achieved. Prior to requesting a meeting, the requestor should confirm the classification of the product with MDD. If the product falls under the MDR, the requestor can request a meeting with the MDD. If Health Canada has deemed the product a device-lead combination product (according to the principal mechanism of action by which the claimed effect or purpose is achieved), it should be indicated on the request form when a meeting is requested. The requestor should send in the classification ruling with the form along with any other information that is required for that meeting type. If the product falls under the FDR, the requestor should contact the responsible Review Bureau for that product to request a meeting and indicate whether MDD participation is required.

How to request a meeting

The requestor should submit via email, in either English or French:

• the completed Device Advice: Meeting Request Form
• an attached cover letter
• any required supporting information

To use the meeting request form properly, download the PDF to your computer and select "Enable all features".

• Preferred meeting format: Meetings can be conducted either face-to-face or via teleconference. The requestor should indicate their preference on the form. Please note that Health Canada will determine the meeting format. The processing time for Health Canada to acknowledge the form is 10 calendar days.
• Proposed meeting date: The requestor should provide 3 or more proposed meeting dates and times on the form. While the requestor should propose dates that best suit their schedule, please keep in mind Health Canada needs sufficient time to process the request, review the submitted information, and schedule both the internal and actual meeting when the necessary team members are available. If the proposed dates do not allow for adequate preparation time or the dates are not suitable, Health Canada may contact the requestor within the allocated processing time to propose alternative dates. Therefore, Health Canada recommends that the meeting request form should be sent 6 weeks in advance of the earliest meeting date requested, keeping in mind the meeting package is due 4 weeks prior to the meeting.
• Questions: Requestors should submit focused questions in the meeting request form template with a detailed rationale highlighting their specific concerns, as well as a supporting rationale establishing the pertinence of each question (for example, gaps/ambiguity in regulations, guidance, standards or research practices, etc.). Questions that can only be answered after a review is completed will not be accepted for discussion at the meeting. Health Canada will provide written feedback in the meeting decision letter if it believes some of the questions can be answered via email.
• Meeting duration: Health Canada will schedule meetings for 1 hour to promote a focused, meaningful discussion. Generally, presentations should not exceed 20 minutes to allow for sufficient time for discussion of the questions/issues. However, if the requestor feels that 1 hour is not sufficient time to discuss their concerns, then they should provide a rationale and a proposed duration time with the meeting request form.

Health Canada will send a meeting decision letter with a unique meeting ID to the requestor either accepting or declining the meeting within 10 calendar days. If Health Canada declines a meeting, the letter will include a rationale for declining the meeting. If Health Canada accepts the meeting, the date, time and location for the meeting will be included. The requestor should contact Health Canada within 1 week of receipt of our communication to confirm the meeting date. The requestor should include the meeting ID number in any future correspondence with Health Canada, as well as when the application is filed.

Meeting package

Once Health Canada has accepted a meeting request and confirmed a meeting date, the requestor should develop an agenda and a presentation based on the questions posed in the meeting request form. In the case of a teleconference, the requestor should provide the teleconference coordinates at least 2 days before the confirmed meeting date. The requestor should not include new questions or discussion topics in the presentation or the agenda, nor raise such issues during the meeting.

The requestor should provide information, based on the meeting type, by email at least 4 weeks in advance of the scheduled meeting:

Health Canada may request to reschedule or postpone the meeting if the meeting package is deficient or not received within the expected timeframe. This allows the requestor to assemble a more complete package. Please note that MDD reserves the right to modify or truncate the proposed agenda as it sees fit to achieve the goals of the meeting.

Advance feedback

Health Canada may provide advance feedback after an internal meeting to request clarification or the incorporation of additional information into the presentation prior to the meeting. The goal of advanced feedback is to help make the meeting more efficient and to address the requestors questions and concerns. Health Canada will generally communicate the feedback through email 1 week in advance of the scheduled meeting. However, if Health Canada feels this information may be better communicated through a teleconference, Health Canada may schedule a call prior to the meeting date. The requestor should email the final agenda and presentation materials to Health Canada at least 2 days in advance of the meeting.

Documenting meetings

The requestor is responsible for taking minutes during the meeting and developing a record of decision using the record of decision (ROD) template for the respective meeting type.

The ROD should summarize the meeting discussion including:

• any agreements or action items
• how substantial or complex issues were resolved

Should the requestor wish to invite another government department to a meeting, the requestor should capture any discussion with or questions posed to another government department in a separate document and not within the ROD.

The requestor should submit the ROD in Word format to Health Canada within 2 weeks of the meeting date. If slides were presented, the actual version used in the meeting or teleconference should be included with the draft minutes as an annex.

If Health Canada does not have any edits to the draft ROD, it will communicate the acceptance of the minutes though email. Health Canada will consider the minutes final.

If Health Canada has edits to the draft ROD, it will send a revised version in track changes to the requestor within 2 weeks of receipt of the ROD. If the requestor agrees with Health Canada's changes, the requestor should accept the track changes in the ROD and return the document to Health Canada within 1 week. If there is a disagreement, the requestor should email the meeting contact outlining the points of disagreement. Communication is intended to address disagreements about the content of the ROD. It is not intended to address differences of opinion with respect to the regulatory or scientific advice provided by Health Canada to the requestor. If there is no resolution to the disagreement, Health Canada will finalize the ROD within 1 week, noting the points of disagreement in the final ROD.

Where to file the request for a meeting

The requestor should save the appropriate request template form, along with any required supplementary information, as separate documents in either.pdf,.doc or.docx format, and email to: hc.devicelicensing-homologationinstruments.sc@canada.ca.

Requestors should direct questions or comments related to this guidance document to: hc.devicelicensing-homologationinstruments.sc@canada.ca.