member Resources

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New Regulatory Bulletins, Consultations & Updates

September 11, 2023 - Health Canada has launched a 60-day public consultation on Draft Guidance for Determining Medical Device Application Type

Health Canada is seeking feedback from medical device manufacturers and other medical device stakeholders on the draft Guidance for determining medical device application type.

This guidance explains the different application types and will help manufacturers determine whether certain medical devices, including components and parts, should be combined and submitted as 1 device licence or authorization application.

In particular, Health Canada would like feedback on the overall clarity and content, criteria for different application types, and examples provided.

The input gathered through this process will be used to finalize the guidance document. The final document will replace the Guidance for the interpretation of sections 28 to 31: Licence application type.

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September 6, 2023 - Health Canada has published an updated MDEL Guidance Document (GUI-0016)

This guidance document is intended for any person in the medical device industry. It replaces GUI-0016 version 8 (April 1, 2020).

Guidance on Medical Device Establishment Licensing (GUI-0016) provides guidance on the regulatory requirements for medical device establishment licences (MDELs), including when and how to apply for an MDEL and how to maintain an MDEL once issued.

The guidance document explains:

• medical devices establishment licensing under sections 44 to 51.1 of the Medical Devices Regulations (MDR) to the Food and Drugs Act (act)
• responsibilities of any person who imports or distributes medical devices in Canada

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August 30, 2023 - Health Canada Consultation on MLMD Draft Guidance Now Open

Share your views: Draft Pre-market guidance for machine learning-enabled medical devices

With the increase in artificial intelligence and machine learning in medical devices, Health Canada has developed the Draft Pre-market guidance for machine learning-enabled medical devices. This guidance:

• helps manufacturers who submit an application for a machine learning-enabled medical device (MLMD)
• outlines our expectations for demonstrating the safety and effectiveness of an MLMD throughout its lifecycle
• introduces a mechanism to pre-authorize planned changes to an MLMD to address risks through a pre-determined change control plan (PCCP)

Health Canada is seeking to engage with medical device stakeholders, including manufacturers of Class II to IV medical devices, regulatory representatives, and machine learning experts.

Health Canada invites you to provide feedback on the overall clarity and content of the draft guidance and has provided a list of specific questions to which they are seeking answers.

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August 28, 2023 - URGENT SURVEY for DIAC Members - Deadline Extended to August 31, 2023

PMRA Impact Assessment - Medical Devices with Preservatives/Antimicrobials

DIAC has been engaging actively with PMRA, Health Canada and Medtech Canada on new PMRA requirements taking effect this year.

On June 5th, a new PMRA requirement went into effect requiring all Class 1 Medical Devices that contain preservatives to have their preservative listed on the PMRA Preservative list. Together with Medtech Canada, DIAC met with PMRA and Health Canada on two occasions, most recently June 30th, 2023. Following the latest meeting, Heath Canada is seeking further industry feedback on all classes of Medical Devices containing Preservatives and/or Antimicrobials (whether they are treated articles or not).

We are URGENTLY seeking member feedback as we have escalated concerns to PMRA and Health Canada relating to the 6-month compliance timeline, the cost-prohibitive nature of the registration process, a lack of industry consultation, and foreseeable Medical Device shortages. This survey is being conducted jointly by DIAC, Medtech Canada, and Food Health & Consumer Products of Canada (FHCP). Individual responses are confidential (we are unable to see who responded unless you provide your contact information).

Survey Now Closed

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August 2, 2023 - Health Canada Licencing Challenges

Medtech Canada has aligned with Health Canada to initiate ongoing meetings regarding licencing submission challenges that its members have been facing. The goal of these meetings is to collaborate and identify issues, resolve concerns and align on future efficiencies.

DIAC members are encouraged to bring forward issues they have faced when applying for medical device licences.

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July 31, 2023 - Health Canada Investigational Testing Authorization (ITA); Notification process to be introduced

A Health Canada Notice in relation to a new notification process for certain types of medical device clinical trials can be expected in the coming months.

In order to assess the safety of clinical trial participants and to gain a broader understanding of medical device clinical trials in Canada, Health Canada plans to introduce a notification process for two types of clinical trials. Prior to enrolling patients in one of these types of trials, information regarding the study (such as investigational site information, a brief description of the device, a brief protocol summary, etc.) would be required to be provided to Health Canada. A Notification Form is being developed to facilitate information collection. 

Once the Notice itself is finalized, it will be shared with Medtech Canada and with DIAC members. Health Canada is open to organizing a call/webinar to discuss further if members have questions. If a webinar is scheduled, information on how to register/attend will be shared with DIAC members in a Regulatory Matters or Regulatory Alert e-comm.

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July 24, 2023 - Health Canada has provided clarification on the importer responsibilities around foreign reporting under Part 1.1 of the Medical Devices Regulations (SOR/98-282)

In response to an inquiry from Medtech Canada, Health Canada provided clarity around the timelines expected to update the regulations. Click here to review the response from Health Canada.

The Medical Devices Regulations (SOR/98-282) can be found on the Government of Canada website here.

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