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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 >>

14

Mar 2023

Reminder: Annual Licence Renewal (ALR) Application Due Date for MDELs is April 1, 2023
Reminder: Annual Licence Renewal (ALR) Application Due Date for MDELs is April 1, 2023
By
The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your completed ALR application before April 1. […] Read More >>

17

Feb 2023

Proposed Changes to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Proposed Changes to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
By
On December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs). The […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: Management of Rolling Reviews for Drug Submissions
Health Canada Draft Guidance Document: Management of Rolling Reviews for Drug Submissions
By
Health Canada is proposing new amendments to the Food and Drug Regulations and Medical Devices Regulations. Part of these amendments include “new provisions that enable the rolling review of a […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
By
On December 21, 2022, Health Canada opened a consultation on a proposal to amend the labelling of pharmaceutical drugs for human use guidance document. The amendments that have been proposed […] 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Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices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 >>

13

May 2022

EU In Vitro Diagnostic Medical Device Regulation
EU In Vitro Diagnostic Medical Device Regulation
By
In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests […] Read More >>

29

Apr 2022

What You Need to Know about EFSA Strategy 2027
What You Need to Know about EFSA Strategy 2027
By
EFSA’s Strategy 2027 delineates the European Food Safety Authority (EFSA) strategies and approaches in responding to the changing environment in the years ahead, especially in light of the SARS-CoV-2 global […] 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 >>

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 >>

26

Nov 2020

Health Canada’s COVID -19 Medical Device Database Can Be Very Misleading
Health Canada’s COVID -19 Medical Device Database Can Be Very Misleading
By
If you are involved in the importation or distribution of Medical Devices related to the COVID crises in Canada, then no doubt you are aware of Health Canada’s online database […] Read More >>

03

Apr 2020

Health Canada announces Interim Order for Class-IV diagnostic devices for COVID-19
Health Canada announces Interim Order for Class-IV diagnostic devices for COVID-19
By
Health Canada has recently released an Interim Order (IO) for the importation and sale of Class-IV medical devices used to diagnose, treat, or prevent COVID-19. **note: An interim order is […] 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 >>

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