Health Canada Draft Guidance on Significant Changes

Guidance for the Interpretation of Significant Change of a Medical ...

Health Canada does not generally consider the addition of new devices which are within the existing range of device sizes already licensed and are of the same ...

Draft guidance on how to interpret 'significant change' of a medical ...

If you determine that the proposed change to a Class III or IV medical device is a significant change and you wish to market the modified device ...

Health Canada Draft Guidance on Significant Changes: Overview

The article highlights the critical points related to the concept of significant changes in the context of medical devices allowed for marketing and use in ...

Webinar: Draft Guidance on How to Interpret "Significant Change" of ...

Priya Bhutani welcomed attendees to a webinar about Health Canada's draft guidance on interpreting significant changes for medical devices.

Health Canada Draft Guidance on Significant Changes - RegDesk

The new article describes specific types of changes to medical devices in detail and outlines the critical points related to the regulatory status thereof.

Health Canada publishes draft guidance for machine learning ...

On August 30, 2023, Health Canada published draft pre-market guidance for machine learning-enabled ‎medical devices. This Guidance helps ...

Updated and new draft Health Canada guidance documents related ...

Updated and new draft Health Canada guidance documents related to medical devices · Updated examples for MDEL and/or medical device licence ...

Christie Hughes, MPH, MLS(ASCP), RCC-IVDR's Post - LinkedIn

Health Canada (HC) has issued updated draft guidance on how to interpret 'significant change' of a medical device. HC updated the guidance ...

Medical Devices Regulations ( SOR /98-282) - Laws.justice.gc.ca

significant change means a change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of ...

Discussion: View Thread - RAPS Quebec Local Networking Group

Changes to Guidance on Medical Device Establishment Licensing (GUI-0016): In view of the new Policy discussed above, Health Canada will update ...

Guidance Document

... important to note that Health Canada reserves the ... Draft Health Canada IMDRF table of contents for medical device application guidance.

Predetermined Change Control Plans for Medical Devices - FDA

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft ...

Proposed Changes to the Guidance on Recognized Standards for ...

Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the ...

Health Canada Revised Significant Change Interpretation Guidance ...

The list for significant and non-significant changes includes: changes in manufacturing processes, facility or equipment; changes in design; ...

Health Canada releases draft pre-market guidance for machine ...

For example, Health Canada has requested feedback whether it should add or remove any information that manufacturers would be required to ...

Health Canada Draft Revised Guidance Documents on Post-NOC ...

In light of these substantial changes, Health Canada has opened a consultation period to solicit comments from industry stakeholders, who may ...

2023 Year in Review—Canada's Top 10 Drug and Medical Device ...

The 2021 Amendments also expanded Health Canada's authority to compel information from DEL holders so that Health Canada can assess the reasons ...

Pharma in brief - Health Canada releases for consultation Draft ...

The draft guidance document outlines the conditions and procedures by which Health Canada administratively processes a change in manufacturer name and/or ...

Finally! Health Canada's New Guidance on the Distinction Between ...

Other Notable Changes · A health product manufacturer does not sponsor only specific portions of the agenda that are product-related; · The agenda ...

SOR/2024-136 - Gazette du Canada

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product ...