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07

Oct 2024

Health Canada Introduces the Regulatory Enrolment Process (REP) for Medical Devices
Health Canada Introduces the Regulatory Enrolment Process (REP) for Medical Devices
By
Health Canada has recently launched a significant update to streamline the submission process for medical devices. The Medical Devices Directorate (MDD) is now offering the Regulatory Enrolment Process (REP) as […] Read More >>

06

Jun 2023

How To Get a Pregnancy Test to Market in the United States and Canada
How To Get a Pregnancy Test to Market in the United States and Canada
By
Definition of a Pregnancy Test A urine pregnancy test device is an In-Vitro Diagnostic (IVD) hormonal assay that measures the beta (β) subunit of Human Chorionic Gonadotrophin (hCG) levels in […] Read More >>

01

Feb 2023

Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
By
Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is […] Read More >>

03

Nov 2022

Monkeypox Testing – U.S Pathways to Licensing
Monkeypox Testing – U.S Pathways to Licensing
By
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>

22

Sep 2022

Monkeypox Testing – Canadian Pathways to Licensing
Monkeypox Testing – Canadian Pathways to Licensing
By
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. While appearing similar to smallpox, it is […] Read More >>

12

Jul 2022

How Much Does it Cost to Get an MDEL & MDL Approval?
How Much Does it Cost to Get an MDEL & MDL Approval?
By
The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down […] Read More >>

15

Jun 2022

How Much Does it Cost to Get a 510(K) Approval?
How Much Does it Cost to Get a 510(K) Approval?
By
This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this […] Read More >>

31

May 2022

ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
By
The new European Union In Vitro Diagnostics Regulations (EU IVDR) entered into application on May 26, 2022, to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC). Manufacturers, authorized representatives, importers, and […] Read More >>

19

Apr 2022

Interim Order Number 3 for Medical Devices is Now in Effect.
Interim Order Number 3 for Medical Devices is Now in Effect.
By
Health Canada’s use of Interim Orders (IOs) has allowed for the exceptional importation and sale of Medical Devices (MDs) to help prevent shortages in relation to COVID-19. To date, Health […] Read More >>

14

Apr 2022

How to Get a CE for a Medical Device
How to Get a CE for a Medical Device
By
Medical devices in the European Union (EU) are approved through a different mechanism than the approval process in the United States or Canada. The approval of medical devices intended for […] Read More >>

28

Mar 2022

How is Digital Health Regulated in Canada?
How is Digital Health Regulated in Canada?
By
As innovation continues to evolve in digital health technologies, Health Canada is undertaking an adaptive initiative to support better access to those therapeutic products, especially in relation to medical devices. […] Read More >>

18

Mar 2022

How is Digital Health Regulated in the U.S?
How is Digital Health Regulated in the U.S?
By
Digital Health covers a broad scope of categories in mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health tools range from mobile medical […] Read More >>

26

Jan 2022

How to Get Your COVID-19 Tests to Market in the U.S
How to Get Your COVID-19 Tests to Market in the U.S
By
During the pandemic of respiratory disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or Coronavirus Disease 2019 (COVID-19), the FDA Commissioner may authorize the use […] Read More >>

12

Jan 2022

How to Get Your COVID-19 Tests to Market in Canada
How to Get Your COVID-19 Tests to Market in Canada
By
COVID-19 tests are considered medical devices and are regulated under the Medical Devices Regulations in Canada. Medical devices are classified into 4 classes: Class I are those with the lowest […] Read More >>

12

May 2021

Amazon Updates US Requirements for Medical Gloves
Amazon Updates US Requirements for Medical Gloves
By
Amazon has made changes on Seller Central, this time to their policies for medical gloves sold on their marketplace. Sellers on Amazon are being alerted to new forms of documentation […] Read More >>

03

Apr 2020

New FDA Guidance Updates on Gowns, Gloves and Other Apparel in response to COVID-19
New FDA Guidance Updates on Gowns, Gloves and Other Apparel in response to COVID-19
By
The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in […] Read More >>

21

Jun 2019

What You Need to Know About Software as a Medical Device
What You Need to Know About Software as a Medical Device
By
Software is used extensively in medical devices for gathering, monitoring, and transmitting data to healthcare professionals and clinical technicians. Although software can be an extremely useful tool as a medical […] Read More >>

29

Mar 2019

Health Canada – Illegal Marketing of Drugs and Devices Program
Health Canada – Illegal Marketing of Drugs and Devices Program
By
Health Canada has recently announced the initiation of the Stop Illegal Marketing of Drugs and Devices (SIM-DD) program. Health Canada’s introduction of this particular program is part of its contribution […] Read More >>
Consumer Advertising Guidelines for Marketed Health Products from 2006 Receives Update!
October 28, 2016 By
Advertising Standards Canada prepares revised guideline for claims that can be made on marketed health products with new guidance for medical devices and vaccines. On September 23, 2016 the Advertising […] Read More >>
Regulatory Barriers to Trade for Consumer Health Products
May 28, 2012 By
By Dr. John Harrison, PhD, MSc, BSc Senior Government Relations Advisor So you want to import a consumer health product from the U.S.A. to Canada. Good luck! There are many […] Read More >>

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