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Global Medtech Guidance Tracker: April 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.

Guidance Documents Regulation

English, Canadian and US HTA Bodies Team Up On Unpublished Clinical Data Transparency Drive

NICE, CADTH and ICER say they have taken a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies.

Policy United Kingdom

How Authorities Should Communicate Globally About Device Threats

Only those countries signed up to the International Medical Device Regulators Forum are automatic members of the new global communication system for risky devices and IVDs.

International Europe

Global Medtech Guidance Tracker: March 2023

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

Guidance Documents Regulation

Canada Consults On Policy Changes For Registering Clinical Trials And Disclosing Results

Health Canada is taking steps to improve transparency on authorized clinical trials and is creating a new trials search portal.

Clinical Trials Guidance Documents

Global Medtech Guidance Tracker: February 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

Global Medtech Guidance Tracker: January 2023

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

Guidance Documents Regulation

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
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