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26

Jun 2026

FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
By
On February 2, 2026, the FDA’s revised Quality Management System Regulation (QMSR) officially became effective, replacing the long-standing Quality System (QS) Regulation framework under 21 CFR Part 820. While the […] Read More >>

26

Jun 2026

Health Canada Finalizes Phase 2 MDEL Modernization: What Importers Need to Know
Health Canada Finalizes Phase 2 MDEL Modernization: What Importers Need to Know
By
Health Canada has finalized the second phase of its modernization of the Medical Device Establishment Licence (MDEL) framework, publishing amendments to the Medical Devices Regulations in the Canada Gazette, Part […] Read More >>

12

Jun 2026

AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
By
Artificial intelligence is changing the way regulators evaluate medical devices, particularly where software functionality influences clinical decision-making or adapts over time. While software regulation is not new, machine learning introduces […] Read More >>

02

Mar 2026

ISO/IEC 42001:2023 explained – What it means for AI governance
ISO/IEC 42001:2023 explained – What it means for AI governance
By
Artificial intelligence is no longer experimental in regulated industries. It is being used to monitor claims, scan clinical literature, validate labels, screen ingredient risks, predict quality trends, and surface early […] Read More >>

27

Aug 2025

Integrated framework for point-of-care diagnostic validation
Integrated framework for point-of-care diagnostic validation
By
dicentra published a new JALM article (Aug 2025) presenting a staged framework that integrates analytical validity, clinical validity, clinical utility, regulatory strategy, and integrated evidence generation. Regulatory Approved Point-of-Care Diagnostics Read More >>

06

Jun 2025

FDA’s AI Rollout: What Elsa and CDRH-GPT Mean for Regulatory Submissions in the U.S.
FDA’s AI Rollout: What Elsa and CDRH-GPT Mean for Regulatory Submissions in the U.S.
By
On June 2, 2025, the U.S. Food and Drug Administration (FDA) officially launched Elsa, a generative AI tool designed to assist FDA staff with core functions such as reviewing clinical […] Read More >>

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 >>

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 >>

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