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The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

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

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.

Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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