Global Medtech Guidance Tracker: July 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.

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Twenty-nine guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’sGuidance Tracker in the past month.

The updated tracker includes a draft guideline by Health Canada on using standards to support compliance with the Medical Device Regulations.

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FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Global Medtech Guidance Tracker: April 2025

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.

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‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 

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Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 

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