The new Australian regulatory framework for in vitro diagnostics has been published into law and will apply from 1 July. It provides a four-year transition period for IVDs under the current regulatory framework to comply with the new requirements ...

The European Commission has issued a document clarifying certain legal obligations arising from the Customs Union Agreement that was signed between Turkey and the European Community for medical devices 1 ,2 . Specifically, the "interpretative ...

India's regulatory agency for devices and drugs is seeking feedback on a draft guideline that explains the submission format for obtaining licences to import medical devices into the country 1 . The draft document from the Central Drugs Standard ...

The medtech industry has expressed concern over draft proposals from the US Food and Drug Administration to disclose to public information on medical devices and drugs that have not yet been approved 1 . Disclosing information on pending device ...

In a move that promises to improve the quality of communication of medical information and images via so-called fourth-generation mobile technology, the European Commission has adopted a decision establishing harmonised technical rules for member ...

A new industry association comprised of Turkey’s top medtech companies is in the process of creating a robust code of ethics and pushing for regulatory updates. Altay Akbulut of Eczacibaşi-Baxter Hospital Supply spoke at the 2010 international ...

The Irish Medicines Board , having found no takers for a new service it started last year to offer formal scientific advice on the drug component of drug/device combination products, is planning to charge a reduced fee for the job 1 ,2 . Reacting to ...

The Human Fertilisation and Embryology Act 2008 came into force in the UK on 1 October 1 ,2 . The law ensures that all human embryos outside the body – whatever process used in their creation – are subject to regulation, said the Department of ...

The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to address the issue 1 . In addition to requiring ...

The new Australian regulatory framework for in vitro diagnostics has been published into law and will apply from 1 July. It provides a four-year transition period for IVDs under the current regulatory framework to comply with the new requirements ...

The European Commission has issued a document clarifying certain legal obligations arising from the Customs Union Agreement that was signed between Turkey and the European Community for medical devices 1 ,2 . Specifically, the "interpretative ...

India's regulatory agency for devices and drugs is seeking feedback on a draft guideline that explains the submission format for obtaining licences to import medical devices into the country 1 . The draft document from the Central Drugs Standard ...

The medtech industry has expressed concern over draft proposals from the US Food and Drug Administration to disclose to public information on medical devices and drugs that have not yet been approved 1 . Disclosing information on pending device ...

A new industry association comprised of Turkey’s top medtech companies is in the process of creating a robust code of ethics and pushing for regulatory updates. Altay Akbulut of Eczacibaşi-Baxter Hospital Supply spoke at the 2010 international ...

The European Commission , in its exploratory process on the future of medical devices, has revealed a consensus among stakeholders that there is a need to develop new tools and mechanisms to evaluate the impact of innovation on the sector 1 ,2 . In ...

The European Commission , along with authorities in China, has upgraded an existing online platform that lists technical standards being used in the medical device and other sectors in the two markets 1 . The upgraded platform is expected to ...

US healthcare facilities and manufacturers are being warned about the risks to patients if flexible endoscopes and their accessories are not properly processed. In a safety communication, the Food and Drug Administration , the Centers for Disease ...

US biotech companies are worried that recommendations of a government task force on gene patenting and licensing, if implemented, could restrict the ability to obtain, or undermine the enforceability of, patents and exclusive licences with respect ...

European companies operating in China remain concerned that confidential data submitted by them during patent filing, product registration and other stages of business development are leaked to their Chinese competitors 1 ,2 . While China has taken ...

The US Patent and Trade Mark Office has withdrawn controversial rules issued by the previous administration that sought to limit the size of patent applications 1 . The rules were published in a Federal Register notice in August 2007; they were ...

Member states of the World Intellectual Property Organization have agreed to streamline and simplify the existing international registration system for industrial designs from 2010 1 ,2 . The Hague Agreement Concerning the International Deposit of ...