Articles

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  • 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
  • CASE STUDY: HOW ONE MEDTECH COMPANY IS GAINING ACCESS TO SIX NEW MARKETS WITH ONE UNIVERSAL SOLUTION

    Posted on Dec 11, 2014
    Luminex Corporation is a biotechnology company based in Austin, Texas, USA with offices in Madison, WI, , Canada, China, Japan, and the Netherlands. Luminex develops, manufactures, and markets products like the Multi-Analyte Profiling (xMAP) technology, which allows simultaneous analysis of up to 500 bioassays from a small sample volume and is being used within various segments of the life sciences industry, including the fields of drug discovery and development, clinical diagnostics, genetic analysis, bio-defense, food safety, and biomedical research.
    With USA FDA clearance, CE Mark, Health Canada approval, PMDA notification, and CFDA approval, Luminex was looking to expand their business into new markets. Their sales team developed a strategic plan for a set of target countries. The regulatory department was tasked with evaluating partners for registration of their high-class in vitro diagnostic devices... Continue reading
  • COUNTRY AT A GLANCE: ETHIOPIA

    Posted on Oct 30, 2014
    The Federal Democratic Republic of Ethiopia, situated in the Horn of Africa between Eritrea, Djibouti, Somalia, Sudan, South Sudan, and Kenya, has the second highest population in Sub-Saharan Africa estimated at nearly 88.8 million people in 2014. Its ecosystem is diverse, ranging from mountains to jungle to hot lowlands, to the banks of the Nile and many rivers. Ethiopia is a founding member of the United Nations and is actively involved in the African Union.

    Ethiopia’s economy has grown in recent years after decades of low rankings in the global economy; it now has the largest economy in East and Central Africa. Government reforms across a broad range of institutions and structures have paid off with significant reductions in poverty rates, improved health and education indicators, increased agricultural infrastructure and production, and more. In 2013, Ethiopia’s GDP continued to grow at more than twice the regional average rate (10.4%)... Continue reading
  • 510(k) PERFORMANCE: 11 CLEARED DEVICES IN 16 MONTHS WITH LICENSALE.COM™

    Posted on Sep 30, 2014
    The summer of 2014 marked an important milestone for LICENSALE.COM™, Arazy Group’s product registration system. Hanin Medical’s SAAD patient monitor, the first Saudi designed and manufactured device of its kind to be cleared for sale in the EU and USA, received its 510(k) clearance in August 2014. Although this was an achievement on its own, it was the latest in an unbroken period of 11 successful 510(k) clearances submitted between 2013 and 2014.

    Read more for the stories of six of the eleven MedTech manufacturers who discovered how LICENSALE.COM™ could get their products to market faster and at lower cost through three key strategies... Continue reading
  • COUNTRY AT A GLANCE: CHILE

    Posted on Sep 18, 2014
    The Republic of Chile is situated along the Andes mountains on the Pacific Coast, bordering Peru, Bolivia, and Argentina. With a population of over 17.6 million people, its geography ranges from mineral-rich desert in the north, metropolitan cities in the centre, and forests, valleys, volcanoes, islands, and lakes in the south. One of Latin America’s leading nations in economic, social, political, and environmental measures, Chile was the first South American country to join the OECD.

    In 2012, the WHO reported total health expenditure at 7.2% of the GDP or USD $1606 per capita, ranking Chile as one of South America's top spenders on healthcare and the highest per capita spender in Latin America. According to a 2009 report from the government of Switzerland, 43% of medical devices in Chile are... Continue reading
latest news
  • Jul 17 2017
    REGULATORY UPDATE - XERIDIEM

    UAE: Xeridiems' Entuit Family was approved for sale with LICENSALE.COM®. ...

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  • Jul 17 2017
    NETHERLANDS TO USE FDA-STYLE UDI SYSTEM FOR MEDICAL DEVICES

    A US-style unique device identification (UDI) coding system for medical devices will be introduced in the Netherlands next year....

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  • Jul 10 2017
    FDA FINALIZES LIST OF CLASS II DEVICES EXEMPT FROM PREMARKET NOTIFICATION

    The US Food and Drug Administration (FDA) has announced a list of 1,003 class II device types that it believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety...

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  • Jun 27 2017
    2017 RAPS REGULATORY CONVERGENCE: BOOTH 300/SEPTEMBER 12 LECTURE, 1.15PM

    MedTech regulatory affairs professionals managing the launch of products in new markets and maintaining market approval globally will benefit from the invaluable insights shared during the ‘Regulatory Strategies & Techniques for Faster Market Access’ sess...

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  • Jun 13 2017
    FDA TO REQUIRE NEW VALIDATION DATA FOR LIST OF REUSABLE MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has unveiled a list of reusable medical devices for which it will require validation data regarding cleaning, disinfection and sterilization as well as validated instructions for use in premarket notification subm...

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