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  • KEEP YOUR 510(K) APPLICATION ON TRACK: 3 QUESTIONS TO ENSURE UDI COMPLIANCE

    Posted on Jun 11, 2015
    The phase-in of the Universal Device Identifier (UDI) program by the US FDA begins its second phase this September, marking a grey area for manufacturers of Class II medical devices. UDI labels allow manufacturers and regulatory bodies to effectively mark and identify medical devices through a globally harmonized system for improved traceability and patient safety. The United States introduced the law, which will be implemented over seven years, in 2013.

    It is sometimes unclear, however, when and how medical and IVD device manufacturers should conform to UDI. Some large companies have been using the UDI system for years, but many smaller companies have not. Under new regulations, 510(k) applications submitted with non-UDI labelling may be delayed during the 510(k) review if the UDI due date for the device type becomes a requirement during the 510(k) review.

    Manufacturers with Class II devices should ask three questions... Continue reading
  • COUNTRY AT A GLANCE: BRAZIL

    Posted on May 28, 2015
    As both the fifth largest and fifth most populous country in the world, Brazil covers 8.5 million square kilometres and is home to 203 million people. Though per capita spending is low due to a concentration on spending in urban areas, the country’s large population means that its healthcare market – Latin America’s largest – is already of major significance and has huge potential for further growth.

    As a result, Brazil’s medical device market was estimated to be worth USD $5.6 billion by Espicom in 2013 and is expected to grow at a CAGR of 13.3% between 2013 and 2018, reaching an estimated USD $10.6 billion. Continue reading
  • 5 QUESTIONS & ANSWERS: THE CANADA-EU COMPREHENSIVE ECONOMIC AND TRADE AGREEMENT (CETA) & THE MEDTECH INDUSTRY

    Posted on Apr 16, 2015
    An interview with Josh Smith, Manager with International Trade Policy at the Government of British Columbia, Canada. CETA refers to the Canada-EU Comprehensive Economic and Trade Agreement (CETA), which is Canada’s most ambitious trade initiative to date and has a scope that is broader than the historic North American Free Trade Agreement (NAFTA). When it comes into force, Canada will be the only G7 country to have preferential access to... Continue reading
  • COUNTRY AT A GLANCE: SPAIN

    Posted on Apr 16, 2015
    The Kingdom of Spain, a constitutional monarchy and member of the European Union, is located in southwestern Europe along the Mediterranean Sea and the Atlantic Ocean and bordered by Portugal, France, and Andorra. Spain is the second largest country in the European Union and has the fifth largest economy. Famous for its mountains, coastlines, rivers, and vibrant culture, Spain's population of 46.6 million enjoys one of the highest life expectancies in the eurozone.

    Spain has the fifth largest medical device market in Western Europe and the 12th largest market worldwide, valued by Espicom at USD $4.9 billion in 2013. Three quarters of medical devices are... Continue reading
  • 5 THINGS TO KNOW ABOUT UPCOMING FDA GUDID REQUIREMENTS

    Posted on Mar 26, 2015
    An interview with Raymond Kelly, Chief Regulatory officer at Arazy Group Consultants Inc., on upcoming requirements for the US FDA GUDID program. The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the U.S. Food and Drug Administration (US FDA) that serves as a reference catalog for every device with an identifier. Identifiers are intended to support post-market activities such as reporting, monitoring, analyzing adverse event reports, and recalls. The UDI law is being introduced based on device risk classification with the highest risk (Class III) devices required to comply by September 24, 2014 and the lowest risk devices by... Continue reading
  • COUNTRY AT A GLANCE: TAJIKISTAN

    Posted on Mar 26, 2015
    Located in Central Asia, the Republic of Tajikistan is a mountainous, landlocked country, bordered by Afghanistan, Uzbekistan, Kyrgyzstan and China. A presidential republic comprising four provinces, it spans over 140 000 km2 and is home to more than 8 million people. The population of Tajikistan is young and growing rapidly, with more than half of the country below 25 years old. Such demographic shifts are dictating the direction of the government, which is focused on reforming the critical agriculture sector, reducing poverty, creating jobs, and improving public services such as healthcare. Continue reading
  • COUNTRY AT A GLANCE: FRANCE

    Posted on Mar 12, 2015
    France has one of the top five largest medical device markets in the world, according to a report from Espicom, and the market is estimated to be worth USD $14.4 billion in 2013. The French government is attempting to curtail spending on medical devices in line with Europe’s trend towards austerity in the wake of the global financial crisis; however... Continue reading
  • COUNTRY AT A GLANCE: AUSTRALIA

    Posted on Feb 12, 2015
    The Commonwealth of Australia is one of the largest countries in the world, comprising one large landmass and several small islands located in the Pacific and Indian oceans. Australians spent approximately USD $133.8 billion on healthcare in 2015 (9.1% of GDP), most of which was spent by the federal and state/territory governments (according to the Medical Technology Association of Australia’s report). Per capita spending, set at USD $5663 in 2014, has doubled in the last ten years. The local medical device manufacturing market is significant, with over 500... Continue reading
  • LICENSALE.COM™ RECOGNIZED AS GAME-CHANGING INNOVATION BY FROST & SULLIVAN

    Posted on Feb 12, 2015
    Arazy Group is proud to announce two prestigious Frost & Sullivan awards earned by our company this week. Read more for an interview with Jeff Moad, Research Director & Executive Editor at Frost & Sullivan, on why Arazy Group was recognized, including in the most prestigious category of the night... Continue reading
  • COUNTRY AT A GLANCE: MEXICO

    Posted on Jan 29, 2015
    With a population of over 122 million, Mexico is the second most populous country in Latin America and the eleventh most populous in the world. The country is a federal republic composed of thirty one states and spanning nearly two million square kilometres. Economically, Mexico is a major player on the world stage; in 2013, their GDP was estimated at $1260 billion USD, or 2.0% of the world economy, with an annual growth rate of... Continue reading
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