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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.

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.

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

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. Forty-three documents have been posted on the tracker since its last update.

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.