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Global Medtech Guidance Tracker: April 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.
News We’re Watching: Lung Preservation System Goes National, De Novo For MMI, Brazil’s ANVISA To Recognize Overseas Approvals
This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.
New UAE Regulator Calls On Drug and Device Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.
Global Medtech Guidance Tracker: February 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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