member Resources

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New Regulatory Bulletins, Consultations & Updates

November 12, 2023 -  International Civil Aviation Organization (ICAO) Proposed Amendments to Air Transportation Regulations Affecting Shipments of Medical Devices

On November 12, 2023, Medtech Canada, alongside other International Associations such as Advamed and Medtech Europe, submitted a Joint Association letter to the ICAO Dangerous Goods Panel Chairman expressing shared concerns with the proposed regulations on the transport of dangerous goods aboard aircraft to be considered at the International Civil Aviation Organization (ICAO) Dangerous Goods Panel on November 13th, 2023.

These concerns are related to proposals impacting international air shipments of medical devices containing batteries and their significant impact on patient Care, operational, and cost implications for the medical industry. Subsequently, on November 13th, a meeting took place at which feedback was provided on these critical concerns.

Click here to review a summary of the feedback provided, courtesy of Medtech Canada.

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November 15, 2023 - Health Canada Revised Notice: Implementing the regulatory enrolment process (REP) for medical devices regulatory activities

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. The REP will be used to collect information from manufacturers on the company, dossiers, devices, regulatory activities and transactions. It consists of a set of web-based templates that generate REP Extensible Markup Language (XML) files upon completion.

Before using this process for the first time, manufacturers should become familiar with REP templates, help instructions, CESG requirements, and the REP medical device guidance document. These items will be posted on our REP information web page by December 2023.

Health Canada intends to make REP mandatory within 18 months from the implementation date.

Learn More

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November 1, 2023 - Medtech Canada: MDSAP 2023 Forum

The Medical Device Single Audit Program (MDSAP) is a regulatory audit program that allows a medical device manufacturer to have a single quality management system audit to satisfy the requirements of all participating regulatory authorities.

Official MDSAP members include regulatory authorities from Australia, Brazil, Canada (Health Canada), Japan and the USA. Official observers in the MDSAP program are the World Health Organization (WHO), European Union (EU), and the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom. The MDSAP program also has affiliate members from Israel, Korea, Mexico, Singapore and Taiwan.

Medtech Canada recently participated in the MDSAP 2023 Forum and the documents provided on our Member Communications page may be of interest to DIAC members in understanding MDSAP and Medtech Canada's role in developing the program.

Please note, these resources are available only to DIAC members. Log in credentials are required to visit the Member Communications page.
If your company is a DIAC member company but you do not have a username and password for this website, please contact info@diac.ca to request access.

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October 24, 2023 - Health Canada has published Guiding Principles developed with the US FDA and UK MHRA on pre-determined change control plans (PCCPs) for machine learning-enabled medical devices (MLMD)

This document builds on a 2021 joint publication with Medtech Canada on general principles for Good Machine Learning Practice (GMLP), and provides foundational considerations for robust PCCPs.

Advancements in digital health technologies include artificial intelligence/machine learning-enabled medical devices (MLMDs). Regulatory expectations that are aligned with best practices for development and change management, such as those described in the GMLP guiding principles, can help to support the quality of such devices. Ultimately, this can lead to patient benefits such as earlier access to innovative technologies or more accurate diagnoses.

The change management process helps to ensure the ongoing safety and effectiveness of devices in the face of change throughout the device's total product lifecycle (TPLC). However, certain changes to MLMDs, such as changes to a model or algorithm, may be substantive or significant. For this reason, they can require regulatory oversight, such as additional premarket review. Such regulatory expectations may not always coincide with the rapid pace of MLMD development.

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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

READ MORE

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