Articles

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  • 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
  • 101 COUNTRIES AND COUNTING: MEDTECH COMPANIES GAIN ACCESS TO GLOBAL MARKETS WITH LICENSALE.COM™

    Posted on Sep 18, 2014
    VANCOUVER, CANADA (SEPTEMBER 2, 2014): In a testament to its rapid adoption and unprecedented success since its official launch 18 months ago, online MedTech registration system LICENSALE.COM™ continues to expand its pre-market approval capabilities into new markets around the world, now totalling 101 countries.

    Tried and tested through complex registrations by multinational MedTech companies like Elekta, Physio Control, Toshiba, SPD, Luminex, FujiFilm Sonosite, P&G, T-DOC/Laborie, C Bard, and many smaller manufacturers and start-up companies, LICENSALE.COM™ is successfully processing thousands of applications for devices of all classes from Latin America to Central Asia, the Middle East, Sub-Saharan Africa, and more. Continue reading

  • COUNTRY AT A GLANCE: BOLIVIA

    Posted on Aug 28, 2014
    The Plurinational State of Bolivia is an ethnically diverse South American country sharing borders with Argentina, Brazil, Chile, Paraguay, and Peru. A democratic republic of 10.5 million people, Bolivia is one of the countries with the highest biodiversity in the world resulting from a diverse geographic landscape ranging from the tropics to desert and Andes mountains to basins and the Amazon Rainforest.

    Though Bolivia has long struggled with high levels of poverty, indicators place the country only behind Peru in economic vibrancy in the region due to the excellent performance of recent years. In the past seven years, the GDP has tripled to USD $30.6 billion in 2013 (up 7%) and the International Monetary Fund (IMF) predicts growth of 5.1% in 2014, attributed to popular and prudent fiscal policies. Global Research and Data Services estimates the growth rate for the medical device market in Bolivia to be among the strongest in the world at... Continue reading
  • COUNTRY AT A GLANCE: KENYA

    Posted on Jul 31, 2014
    The Republic of Kenya is an equatorial East African country sharing borders with Tanzania, Uganda, South Sudan, Ethiopia, and Somalia on the Indian Ocean. Its population of 44 million people constitutes the strongest economic state in Southeast and Central Africa with a diversified economy. Though poverty and a degree of political unrest persist, Kenya has made dramatic progress in reducing key indicators of underdeveloped countries. Major changes in Kenya’s government are ongoing following the election in 2013, which has been accompanied by stable growth overall, particularly economically.

    Espicom estimates the value of Kenya's medical device market at USD $100 million in... Continue reading
  • 4 STEPS TO COMPLY WITH EU DIRECTIVE RoHS 2

    Posted on Jul 31, 2014
    The EU’s new directive regarding the Restriction of use of certain Hazardous Substances (RoHS) in electrical and electronic equipment (EEE) came into effect for medical devices as of July 22 2014.

    RoHS 2, or Directive 2011/65/EU, was intended to improve regulatory conditions through a “simple, effective, and enforceable Directive” that aims to harmonize EEE regulations with other changes to the rest of EU legislation. Since it entered into force in 2011, Member States were required to incorporate it into national law by 2013. July 22nd of this year is the date when the law comes into effect for most medical devices, though some devices are exempt... Continue reading
  • COUNTRY AT A GLANCE: MALAYSIA

    Posted on Jun 25, 2014
    Malaysia is a Southeast Asian country bordering Singapore, Vietnam, Indonesia, Brunei, and the Philippines on the South China Sea. It is separated geographically into Peninsular Malaysia and East Malaysia and the population exceeded thirty million people in 2014 estimates. Malaysia’s equatorial climate spans islands, coastlines, tropical rainforests, and mountainous regions. It is active in regional and international affairs as a founding member of ASEAN (Association of Southeast Asian Nations), among others, and has established numerous free-trade agreements with its neighbours and international partners.

    Medical tourism in Malaysia has grown as the country establishes itself as a top destination for medical services. Government spending in healthcare has increased both to meet the needs of an aging population and in an attempt to address staff shortages and reduced access to care in rural areas. Espicom estimates that the medical device market in Malaysia will grow at a CAGR of 13.5% to USD 2.7 billion by 2018, almost double the size of 2013. Growth has... Continue reading
  • THE CANADIAN ADVANTAGE: INFLUENCERS ON THE GLOBAL REGULATORY STAGE

    Posted on Jun 25, 2014
    Though only about 20% of medical devices in Canada are manufactured domestically (the majority of imports coming from the United States) and the manufacturing sector is fairly small (about 2% of the global industry), Canada ranks as the ninth largest MedTech market in the world. Valued in 2013 at USD $6.8 billion or USD $195 per capita, it is expected to grow at a CAGR of 4% between 2013 and 2018. Continue reading
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