The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet "Safe Medical Devices in Canada” and the “Classification of Products under the Food and Drugs Act (F&DA) ”.
COVID-19 Latest developments on drugs and health products related to COVID-19.
COVID-19 rapid antigen testing devices that use serial testing for asymptomatic individuals: Notice to industry [2021-07-09] Guidance for transparent medical mask technical specifications [2021-06-30] Cancellation of MDELs for failure to pay fees [2021-06-24] Off-label advertising and sale of rapid antigen tests under workplace screening program: Interim Enforcement approach [2021-06-15] Priority COVID-19 test applications: Notice to manufacturers, importers and distributors[SN1] [2021-05-07] Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice [2021-05-03] Second Interim Order on Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2021-03-01] Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users [2021-03-01] Foreign risk notification for medical devices guidance document: Background [2021-01-14] Amendments to the Food and Drugs Act: Guide to new authorities [2021-01-14] Incident reporting for medical devices: Guidance document [2021-01-14] Guidance on summary reports and issue-related analyses for medical devices: Overview [2021-01-14] Notice: New regulations strengthening the post-market surveillance and risk management of medical devices in Canada [2020-12-23] List of regulatory agencies and foreign jurisdictions [2020-12-23] Medical devices compliance program bulletin [2020-12-03] Notice to Stakeholders: New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19) [2020-11-27] Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 [2020-03-18] COVID-19 health product industry [2020-04-01] Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 [2020-04-05] Medical device shortages [2020-04-05] COVID-19 medical devices [2020-04-30] Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 [2020-05-27] Health Canada's Action Plan on Medical Devices Canadians rely on medical devices to maintain and improve their health and well-being. Canada has one of the best regulatory systems in the world for medical devices, with some of the most stringent requirements. The Government of Canada is taking steps to further ensure the safety, effectiveness and quality of the medical devices used by Canadians.
As announced by the Honourable Ginette Petitpas Taylor, Minister of Health, Health Canada has developed an Action Plan to accelerate its efforts to strengthen the regulation of medical devices in Canada, and to better ensure optimal health outcomes for Canadians.
This plan lays out a three-part strategy to further improve how medical devices get on the market, strengthen monitoring and follow-up for devices already in use, and provide Canadians with more information about the medical devices they rely on.
The Department is pleased to announce that it will begin publishing Regulatory Decision Summaries (RDSs) for amendments to Class III and IV medical devices beginning in December 2019.
Health Canada's Role Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.
What information can you find here? Information about nanotechnology-based health products and food.
This section contains fee information, guidance documents, forms and policies needed to submit all of the different types of applications.
The Activities section contains information supporting Health Canada's regulation of medical devices, including announcements, consultations and fact sheets as well as various projects and committees.
Complete listings of Advisories, Warnings and Recalls for health professionals and the public are available in the MedEffect section.
Medical devices may also require certification by the Canadian Nuclear Safety Commission (CNSC) prior to licensing for operational or servicing activities. Please visit the CNSC Web site and read the certification requirements for more information.
Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device.
We also provide information to support the role of the federal regulatory authority such as the Medical Devices Global Harmonization Task Force, Science Advisory Committees, Association Meetings and Performance Reports. Many of these activities are carried out with the participation of clients, stakeholders and the general public.
The Medical Devices Program Strategic Plan, 2007 - 2012, Building for the Future helps us define our future direction. It emphasizes our commitment to improving our work environment and ensuring the strategic management of our resources.
Related Resources The Health Products and Food Branch Inspectorate is responsible for managing the national compliance and enforcement program for medical devices. This program has an establishment licensing component, a proactive inspection component and a responsive compliance/investigation component.
During the majority of human lifetimes, most people will come into contact with some form of medical equipment, from incubators when a baby is born, to X-ray machines when we fall over as children. Medical technology is constantly developing. Medical equipment can be separated into one of two categories: home based equipment and equipment which is used in professional medical facilities. medical equipment Luxembourg
I think this is an informative post and it is very beneficial and knowledgeable. Therefore, I would like to thank you for the endeavors that you have made in writing this article. All the content is absolutely well-researched. Thanks... 123movies
Hello, I found your blog in a very new directory of blogs. I don’t discover how your website came up, should have been a typo. Your website looks good, use a nice day. Buy marijuana online
Thanks for the good critique. Me and my friend were just preparing to do some research about this. We got a book from our area library but I think I’ve learned more from this post. I am very glad to see such excellent info being shared freely out there.. Buy diamond rings online
This is really interesting, You’re a highly trained writer. I’ve joined with your feed and furthermore , count on witnessing the very good write-ups. Additionally, I’ve shared your websites with our social networks. Buy firearms without ffl
I am sure some of this post is going to blow people’s brains, though this is only the tip of the iceberg. Buy counterfeit money online
Thank you for this kind of information I was looking around all Yahoo to discover it! buy handguns online cheap
Some really good content on this internet site , thanks for contribution. Buy diamond rings online
Because of this , appear you should important researching previously penning. It's possible in order to healthier put up in such a manner. Business Directory
This valuable appearances totally proper. Each one of minimal details have decided thanks to large number with practical experience simple awareness. I'm just excited them just as before significantly. Online Business Directory
Awesome blog. I enjoyed reading your articles. This is truly a great read for me. I have bookmarked it and I am looking forward to reading new articles. Keep up the good work! Business Directory
I discovered your blog web site on google and test just a few of your early posts. Continue to maintain up the excellent operate. I simply extra up your RSS feed to my MSN News Reader. In search of forward to reading more from you in a while!… free temp mail
You need to get upset! Really its a must to take a look past everything and get upset. Generally this will allow you to take the inititive to make things happen. медсестра
Wow! This could be one particular of the most beneficial blogs We have ever arrive across on this subject. Basically Wonderful. I’m also a specialist in this topic so I can understand your effort. fireprotection
Great write-up. I’m a normal visitor of your site and appreciate you taking the time to maintain the nice site. I’ll be a frequent visitor for a long time. https://126.96.36.199/