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Global Medtech Guidance Tracker: January 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Guidance Documents Europe

Global Medtech Guidance Tracker: December 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Regulation Guidance Documents

Global Medtech Guidance Tracker: November 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Shattered Glass Or Broken Ladder: Is the Medtech Industry Becoming More Equal For Women?

Medtech promotes more women to managerial roles than other industries, but senior leadership positions see a significant drop in women representation, indicating a "broken rung" higher up in the leadership ladder.

EU North America

FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts

Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.

FDA Standards

El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

El Salvador Policy

Turkey Notches Up Two Notified Bodies Under EU’s Medical Device Regulation In Two Weeks

There are now 41 notified bodies in total under the EU’s Medical Device Regulation.

Europe EU

Global Medtech Guidance Tracker: October 2023

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

Guidance Documents Regulation

FDA Publishes 5 PCCP Principles For ML Devices In Collaboration With Canada And UK

Five guiding principles for PCCPs for ML devices exemplify international harmonization efforts from regulators.

Artificial Intelligence Regulation

Global Medtech Guidance Tracker: September 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Guidance Documents International

Global Medtech Guidance Tracker: August 2023

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

Guidance Documents Regulation

Canada Updates 18-Year-Old Guide On What Constitutes Advertising

Keeping press releases about a product on the manufacturer's website landing page for more than a year may be considered to be promotional, according to Health Canada's update guidance that includes myriad revisions, including a new section on using social media.

Canada Advertising, Marketing & Sales

Supreme Court Decision Makes Partnerships With International Manufacturers More Crucial For US Firms

Supreme Court finds presumption against extraterritorial reach of US laws, saying Congress never “affirmatively and unmistakably instructed” Lanham Act provisions apply to foreign conduct. Contracting with manufacturers abroad is potential pitfall for protecting trademarks, along with licensing brands to foreign marketers.

Consumer Legal Issues

Global Medtech Guidance Tracker: July 2023

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

Guidance Documents Regulation

News We’re Watching: Quidel Recall, Partnerships For Teladoc And Lifebit, Alaris Cybersecurity Issues

This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.

Commercial Regulation

Global Medtech Guidance Tracker: June 2023

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

Guidance Documents Regulation
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