What is DIAC?
The Dental Industry Association of Canada is a non-profit organization founded in 1978 to serve as a unified voice for the Canadian dental industry, and as a professional leader in our community.
and other key resources.
See the DIAC Member Directory and learn more about the benefits of joining us by visiting our Membership page.
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Exclusive DIAC Member Resources
To access Health Canada and regulatory updates, Future of Dentistry SurveyTM – Research Findings, market data,
educational and other professional resources exclusive to DIAC members (login required), click here.
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Meet 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. It 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!
See the full DIAC Member Directory here.
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News and Updates on Regulatory Bulletins, Consultations
Reported need for and access to oral health care services during the COVID-19 pandemic in Canada
February 8, 2024 – Statistics Canada published an article on the “Reported need for and access to oral health care services during the COVID-19 pandemic in Canada”. The article is an analysis of oral health data collected from Canadians (18+) living in the provinces from March-June 2021 in the 2021 Survey on Access to Health Care and Pharmaceuticals During the Pandemic. Specifically, it focuses on the following questions:
The following are key findings and potential implications for the CDCP (in italics):
Source: Statistics Canada_______________________________________________________________________________________________________________
Government of Canada announces the services covered under the Canadian Dental Care Plan
February 8, 2024 – The Government of Canada announced on February 8th, 2024, further details on the oral health care services that will be covered under the CDCP to prevent and treat oral health issues and disease. The majority of services covered under the CDCP will be available as of May 2024 when the first cohort of CDCP clients will begin to receive services. Some oral health care services such as crowns, initial placement of partial dentures, and general anesthesia will require preauthorization, prior evaluation from an oral health provider, which will be available beginning in the fall of 2024.
The Government is also making the 2023 CDCP established fees available via Sun Life's website to help inform providers ahead of the release of the 2024 fees. Each service covered under the plan will be compensated at 2024 CDCP fees when services start being offered in May. The CDCP will reimburse a percentage of the cost, based on established CDCP fees, which are not the same as the provincial and territorial suggested fee guides. People covered under the CDCP may have to pay an outstanding amount such as a co-payment or additional charges, which would be paid directly to their oral health provider. CDCP fees will be reassessed annually to account for new evidence, inflation, and changes in costs over time.
To limit out-of-pocket costs, oral health providers participating in the CDCP will bill Sun Life directly for the eligible services provided to ensure timely reimbursement. Before receiving any oral health services, people covered under the CDCP should confirm that their provider is participating in the program and whether there may be any costs that will not be covered by the plan.
February 7, 2024 – A letter was sent to Health Canada in April 2023, signed by DIAC, Medtech, Food, Health & Consumer Products of Canada, and the Canadian Consumer Speciality Products Association. The associations collectively called on Health Canada to schedule a meeting as soon as possible to “explore potential solutions, including a discretionary compliance while PMRA works to update the regulations to include all medical devices in their exemption list (including Class I medical devices)”.
In June of 2023, the associations met with representatives from the Pest Management Regulatory Agency (PMRA), Medical Devices Directorate (MDD), and Regulatory Operations and Enforcement Branch (ROBE) to voice their concerns on behalf of the dental industry.
At a meeting on January 15, 2024, Health Canada informed the associations that the concerns of the dental industry were heard, and indicated their intent to initiate proceedings to exclude Class I Medical Devices from the Pest Control Products Regulations. Health Canada has informed the associations that they will send a more formal response once they have more detailed information on timelines, as well as any interim compliance requirements until the changes in the Regulations are implemented. DIAC will communicate this information to the membership once notified by Health Canada.
Thank you to our members who engaged with the surveys conducted by DIAC and Medtech Canada. Through the associations collectively voicing their concerns to Health Canada, a positive outcome was achieved.
Ontario Business Definition and Procurement Thresholds
23 January 2024 – In 2022, the Ontario government introduced the Building Ontario Businesses Initiative (BOBI), an effort to bolster the province’s economic growth and enhance supply chain resilience. The BOBI initiative, which was originally outlined in the Fewer Fees, Better Services Act, 2022, has led to the enactment of the Building Ontario Businesses Initiative Act, 2022. This legislation mandates that public sector entities prioritize Ontario businesses when procuring goods and services below a specified threshold amount. Scheduled to come into effect on April 1, 2024, the BOBI Act will be applicable across all public sector procurements, including hospitals, ministries, agencies, school boards, universities, and various other institutions.
The provincial government held a number of stakeholder engagement sessions during the summer of 2023 and posted the proposed regulation for 45 days on Ontario’s Regulatory Registry. This registry is the platform for the public and regulated entities to participate in developing provincial policy by providing comments on proposed changes as well as developing a better understanding of the provincial policy instruments and how to comply with them.
In terms of how the government is defining an Ontario business, here is the official definition:
(2) In determining whether a business is considered to be an Ontario business for the purposes of the Act, a public sector entity may rely on a representation by the business that it meets the requirements of subsection (1).
Source: Medtech Canada
Federal Dental Care Program Will Exclude 4.4M Uninsured Canadians: Report
17 January 2024 – Millions of uninsured Canadians will be left out of the new federal dental program because their family income is too high, says a report released by the Canadian Centre for Policy Alternatives.
Enrolment began in December for a new federal benefits program, which was developed as a condition of a political pact between the Liberal government and the NDP.
It will see the federal government offer dental benefits to uninsured families with a household income under $90,000 per year, starting with seniors, children under the age of 18 and people with disabilities.
When the program is fully implemented in 2025, the government anticipates the coverage will be available to roughly nine million people. But another 4.4 million individuals who don't have dental benefits of their own will be excluded because of the income cap, the report says.
It would cost $1.45 billion to extend the coverage to people whose income exceeds the cap in 2025, on top of the $3.3 billion already budgeted for in the program that year. The
report, authored by David Macdonald, a senior economist for the think tank, argues that $90,000 is not a particularly large income for a family with two parents and children. The report argues that a universal program wouldn't leave anyone out at all.
NDP health critic Don Davies, who has worked closely with the Liberals on the new dental care policy, said in a media statement his party would like to see the coverage expanded. Davies is also collaborating with the government on the legislative framework for medical drug coverage for Canadians. In the case of pharmacare, the NDP has insisted the coverage must be single-payer and universal, unlike the dental care program. Expanding dental care along the same principles will be a focus for the NDP in the next election, he said.
Health Minister Mark Holland's office did not directly address Macdonald's concerns when contacted for a statement Wednesday, but said the new program is intended to ease the financial barrier to accessing dental health care.
Ottawa plans to gradually enrol eligible participants in the new program over the next 12 months.
The first program members are expected to be able to start claiming dental care expenses in May, though the exact coverage date will vary from person to person.
Source: Laura Osman · The Canadian Press | Full article: CBC.ca
Dental Care Reporting Mandatory While Filing 2023 Taxes
15 January 2024 – Due to the upcoming Canada Dental Care Plan (CDCP), the CRA has updated the tax filing process to support the transparency of dental care in Canada.
Beginning with 2023 tax season, employers must provide information on dental care benefits on T4 and T4A slips, TNMSC recently reported. These reports on whether employees and their families receive dental insurance through their employer will help determine eligibility for the CDCP.
Moving forward, it is mandatory to provide these details each year to avoid penalties. Implementing this standard is to support the CDCP and ensure dental coverage is extended to those currently without employer-provided coverage.
Foreign Credential Recognition Program
15 January 2024 – DIAC joins Dr. James Taylor, Chief Dental Officer of Canada (Public Health Agency of Canada – Government of Canada) in welcoming Employment and Social Development Canada's announcement for EDs, DE and National Oral Health Educators Group.
Congratulations to the Association of Canadian Faculties of Dentistry and the College of Dental Technologists of Ontario on their successful funding submissions! Their project descriptions are below.
Organization: Association of Canadian Faculties of Dentistry
Project name: General Dentistry Gap Assessment and Gap Training Program
Description: The project aims to develop, implement, and evaluate a new pathway leading to certification for Internationally Trained Dentists (ITDs) whose knowledge, skills and abilities are comparable to graduates of accredited dental programs to reduce barriers of FCR processes and reduce time for ITDs to enter labour market. The project will be piloted in three Canadian provinces, the project will pilot in three provinces, Alberta, Ontario, and Quebec.
Organization: College of Dental Technologists of Ontario
Project name: Access to Dental Technology Phase II
Description: This project aims to create a fair, objective and valid credential pathway for domestic and internationally trained dental laboratory associates/assistants who do not have formal oral health education, and direct them to competency assessment, upgrading and/or formal education as needed, to become registered internationally educated dental technologists (IEDTs).
See the ESDC news release here.
Draft Regulations for Quebec Bill 96 Published – “An Act respecting French, the official and common language of Québec”
10 January 2024 –As you well know, Bill 96 entitled Act respecting the official and common language of Quebec, French, is currently a priority issue in Quebec.
The draft regulation amending the Regulation respecting the language of commerce and business has just been published in the Gazette officielle du Québec (only in French for now).
As of January 10, any company and industry has 45 calendar days to send its comments to the Government of Quebec ((submission link to come).
In its turn, Medtech Canada will focus its efforts with the government on key recommendations with which members are aligned. Medtech's recommendations will be shared with its board of directors, then forwarded to the government for presentation and discussion.
Source: Medtech Canada
DIAC Welcomes the Announcement Made on December 11, 2023 Regarding the Canada Dental Care Plan
Health Canada Revised Notice: Implementing the regulatory enrolment process (REP) for medical devices regulatory activities
November 15, 2023 – 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.
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 the next day.
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.
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.
November 1, 2023 – 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.
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)