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Global Medtech Guidance Tracker: July 2021

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

Guidance Documents Regulation

Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips

Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.

Regulation Respiratory

MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief

The fragility of start-ups belies their value in medtech innovation, and they do not need unnecessary regulatory complications.

Europe Regulation

Global Medtech Guidance Tracker: June 2021

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

European Regulatory Roundup, June 2021: Medtech Goes Into Document & Decision Overdrive

Keeping up with the huge volume of work coming out from European bodies intended to support the implementation of the Medical Device and IVD Regulations is industry’s latest challenge.

EU Europe

US Treasury: Devices To Fight COVID-19 Can Be Shipped To Sanctioned Nations Under New Directive

The exemptions allow for face masks, diagnostics and oxygen tanks, among others, to be shipped to Iran, Syria and Venezuela without specific permission.

Coronavirus COVID-19 Policy

One Hurdle After Another: Safely Aligned With EU MDR, Turkish Medtechs Brace For New Efforts On Domestic Front

Alignment with the MDR gave Turkish medtech access to the EU market, but in domestic pricing, costs, reimbursement and payment of hospital debts, industry might feel it is barely at the starting line.

Turkey Policy

Global Medtech Guidance Tracker: May 2021

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

International Europe

Global Medtech Guidance Tracker: April 2021

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

International Europe

Good News For Medtech Regulation In The EU As Turkxit Is Avoided

Turkey and the EU have avoided the equivalent of a Brexit, or Swixit. Medtech trade will continue unhindered now it has been established that the EU/Turkey Customs Union will remain.

Europe EU

Exec Chat: Focus On Protecting Cybersecurity Vulnerabilities That Are Exploitable, Sternum CEO Says

Sternum recently announced a partnership with Medtronic to protect its legacy devices from cybersecurity threats. Medtech Insight chatted with its CEO Natali Tshuva about how her product works.

Exec Chat Regulation

Turkish Medtechs Face The Constant Challenge Of Sailing In Stormy Seas

The pandemic has exacerbated the problems of the Turkish medical device industry, which was already struggling for survival and growth in a hostile policy environment. Local blood bag manufacturer Kansuk Laboratory talked to Medtech Insight about the difficulties it faces.

Turkey Policy
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