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  • 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
  • COUNTRY AT A GLANCE: YEMEN

    Posted on Jun 05, 2014
    The Republic of Yemen, located in the south of the Arabian Peninsula, has a population of nearly 24 million people. It shares borders with Oman and Saudi Arabia, but through its coasts with the Arabian Sea, the Gulf of Aden, and the Red Sea, Yemen is situated near several other Middle Eastern and African countries on major trade routes.

    Yemen employs a unique three-step registration process for foreign manufacturers registering medical and IVD devices in the country. Firstly, the Appointed Agent... Continue reading
  • COUNTRY AT A GLANCE: HONDURAS

    Posted on May 15, 2014
    The Republic of Honduras is a coastal country in Central America, bordering the Pacific Ocean and the Caribbean Sea. At over eight million people, it is located in a mountainous region but is also home to lowland valleys and subtropical jungles. Its geographic vulnerability to natural disaster such as hurricanes has affected Honduras’ development.

    In general, public hospitals and programs are underfunded and under-supplied, with hospital workers going on strike last year. However, the situation looks to be improving. In particular, an initiative to decentralize the healthcare system has led to improved... Continue reading
  • COUNTRY AT A GLANCE: BELARUS

    Posted on Apr 22, 2014
    The Republic of Belarus, located between Russia, the Ukraine, Poland, Lithuania, and Latvia, is an Eastern European country of nearly 9.5 million people. Classified by the World Bank as an upper middle-income economy, Belarus is a member of the Union State of Belarus and Russia, emphasizing the close relationship between the two nations, as well as a member of the Eurasia Economic Community (EEC) and the Commonwealth of Independent States (CIS), made up of former Soviet countries in the region.

    The medical device market is considered underdeveloped, estimated by Espicom at USD $280.9 million in 2013. The Espicom report also notes that 79% of medical devices... Continue reading
  • 3 MORE WAYS MEDTECH REGISTRATION IN BRAZIL IS IMPROVING

    Posted on Apr 22, 2014
    Changes to ANVISA's Good Manufacturing Practice (GMP) requirements from March 31st 2014 may play a critical role in reducing regulatory burdens for manufacturers. In our October article, 3 Ways Registration in Brazil is Improving, we noted that registration of MedTech products in Brazil was exceptionally expensive and lengthy due, in part, to the GMP requirements that could extend time-to-market three to four times past the published duration. Over the past several years, ANVISA’s inability to meet its own commitments for GMP inspections has resulted in lawsuits as manufacturers wait years for product approval.

    But things are taking a turn for the better. The August release of Brazil's Decree 8.007 created room for ANVISA to be more judicious in the application of the GMP requirement, potentially introducing automatic... Continue reading
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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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