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What is DIAC?

DIAC is the Dental Industry Association of Canada.

We provide the industry with networking, regulatory information, collaboration, education, industry data, and government advocacy. We are the unified voice of industry, supporting our members and providing professional leadership in our community. 

Member Benefits

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Members enjoy exclusive access to a wide range of benefits, services, and resources: networking & collaboration, education, professional resources, industry information, government advocacy, regulatory affairs, and industry support. 

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Hear from Hafeeza!

DIAC's New Executive Director, Hafeeza Bassirullah sat down for a quick chat with Melissa Summerfield from Oral Health during the ODA ASM in May 2023.

Here's your chance to learn a little more about Hafeeza's background straight from the source.

Thanks to Melissa Summerfield and Oral Health Group for taking the time and for sharing the video!

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Exclusive DIAC Member Resources


National Dental Care Plan Development

DIAC is actively engaging with Health Canada on behalf of our members as the new National Dental Plan proposed by the federal government is being developed.

  • A small DIAC task force was formed in July 2022
  • A Discussion Paper was submitted to Health Canada on August 5, 2022
  • The DIAC task force met with representatives from the Dental Care Task Force within the Strategic Policy Branch at Health Canada on September 6, 2022
  • The DIAC task force continues to collaborate with Health Canada on this important matter

To learn more about development of the National Dental Plan in Canada and DIAC's involvement in it, click here.

Click ⬆️ to Visit the Future of Dentistry Resource Page

You will have to enter your member login credentials. If you don't have member privileges
on the DIAC website, email info@diac.ca to request access

member Resources

Professional Resources exclusive to members with Health Canada and Regulatory updates, Future of Dentistry Survey, Market Data, and much more!

Click Here for More!

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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.

READ MORE

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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.

READ MORE

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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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Get to Know our Newest DIAC Members:


Hatch Group Inc. is a leading Canadian manufacturer of dental equipment. Hatch Group manufactures advanced dental equipment through innovation and advanced technology. The company's state-of-the-art dental instruments, equipment, and tools are designed based on advanced research. 

Hatch Group is a manufacturer of dental chairs, intraoral X-rays, Smartclave sterilization Class B, Hatch Reader, among others.

Hatch Group ensures that all of their products exceed customer expectations and meet all regulatory requirements to ensure the public safety of patients. The company is also ISO 13485:2016 certified.

Welcome to DIAC, Hatch Group!


Germiphene is a proud Canadian developer, manufacturer, and distributor of products for the healthcare industry with specialization in dental.

Since 1952, Germiphene has set a standard of excellence in the manufacturing and distribution of products for the healthcare industry, specializing in dental. The company began with 10 people in a 2000 square foot facility and has grown to over 100 dedicated employees! The company is located in Brantford, Ontario, and strives to offer a unique product mix focused on quality and value.

In 2019, Germiphene was acquired by Young Innovations, a leading global supplier of professional dental products. With its mission of Creating Smiles, Creating Possibilities, Young focuses on delivering innovative, high-quality products and solutions to clinicians and their patients. 

Welcome to DIAC, Germiphene!


KMB Law has taken a practical and collaborative approach to clients' legal matters for over four decades. KMB Law is a full-service Canadian law firm devoted to serving and empowering individuals and businesses with focused legal solutions that work and propel you forward. Since 1979, KMB Law has been committed to the communities they serve, and growing alongside them, with an approach to law centered on effective guidance and advocacy with enduring results.

Welcome to DIAC, KMB Law!


Medtech Canada is the national association leading the effort to develop and advance Canada's innovative medical technology industry.

Representing approximately 120 medtech companies (ranging from Canadian-owned to multinationals), Medtech Canada works closely with the federal and provincial-territorial governments, health professionals, patients, and other stakeholders to deliver a patient-centered, safe, accessible, innovative, and sustainable, universal healthcare system supported using medical technology

Medtech Canada's mission is to foster a strong, dynamic medical technology sector in Canada, for better health outcomes for all Canadians.

Welcome to DIAC, Medtech Canada!

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