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International Initiative Tackles Paucity Of Rare Disease Devices

What is the importance of medtech in diagnosing and treating rare diseases? This is among the key questions that an international working group aims to address through a collection of articles in the Orphanet Journal of Rare Diseases.

EU United Kingdom

FDA Partners With Health Canada On E-Submission Pilot

The pilot will allow manufacturers to use the same digital application format for regulatory consideration by both agencies. 

Regulation Review Pathway

Global Medtech Guidance Tracker: December 2022

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

Guidance Documents International

Global Medtech Guidance Tracker: November 2022

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

Guidance Documents Regulation

Global Medtech Guidance Tracker: October 2022

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

Guidance Documents Regulation

Global Medtech Guidance Tracker: September 2022

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

Guidance Documents Regulation

Global Medtech Guidance Tracker: August 2022

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

Brazilian Medtechs Leave Gloomy 2021 Far Behind As Exports Hit New High

Brazil's ABIMO medtech industry association reports newly-buoyant levels of export activity, as normal business routines crystalize further in the post-COVID phase. Meanwhile, member companies of the Brazil Health Devices initiative are outperforming industry averages.

Brazil Policy

Global Medtech Guidance Tracker: July 2022

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

Guidance Documents Regulation

Brazil's President Eases Compulsory Licensing Law On Pandemic-Related Products

Companies in Brazil will not have to provide know-how and other detailed information on patents that are subject to compulsory licenses during national or international emergencies, although other provisions of a law passed last year to ease the compulsory licensing process remain in place.

Regulation Intellectual Property

Global Medtech Guidance Tracker: June 2022

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

Guidance Documents Regulation

Medtech Procurement A Victim Of Turkey’s Ongoing Economic Troubles

The devaluation of the Turkish Lira since May is making imports of medical devices more expensive and putting hospital procurement under renewed pressure. The local medtech industry associations TUMDEF and ARTED describe the problems  ̶  and the solutions  ̶  to Medtech Insight.

Turkey Medical Device
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