Other Countries

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.

Supreme Court finds presumption against extraterritorial reach of US laws, saying Congress never “affirmatively and unmistakably instructed” Lanham Act provisions apply to foreign conduct. Contracting with manufacturers abroad is potential pitfall for protecting trademarks, along with licensing brands to foreign marketers.

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

This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.

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.

This week, North Carolina health secretary Mandy Cohen was named the new head of the CDC; Congress debated PAHPA reauthorization; Cala Health launched a Parkinson’s Disease wearable; and IHealth.io was fined for consumer privacy violations.

The Canadian government says stakeholders are “poised for action” to improve the collective response to medical product shortages and has come up with some questions and possible answers as to how best to go about it.

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.

NICE, CADTH and ICER say they have taken a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies.

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.

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.

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

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.

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.

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.