Articles

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  • 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
  • COUNTRY AT A GLANCE: CUBA

    Posted on Mar 27, 2014
    The Republic of Cuba is based on the largest island in the Caribbean, covering over 100 000 km² and comprising of over 11 million people. Its closest neighbours are the United States, the Bahamas, Mexico, the Cayman Islands, Jamaica, Haiti, and the Dominican Republic. Cuba’s political relationships are complex since the Cold War between the United States and the Soviet Union and its communist government has maintained strong ties with China, Venezuela, and Bolivia, which share some of its political and economic philosophies.

    Cuba's public health system (which does not allow for any private care) along with education and sustainable development have produced impressive results. It has the fifth highest life expectancy in the Americas (according to 2013 statistics from the World Health Organization), two spots behind Chile and three behind the United States. Cuba's medical system suffers from a lack of supply of up-to-date technologies and medicines but a high ratio of medical professionals, with the second highest... Continue reading
latest news
  • May 7 2017
    SOUTH AFRICA: ARAZY GROUP LISTS NON ELECTRO-MEDICAL DEVICES ON BEHALF OF MANUFACTURERS

    Arazy Group Consultants Inc. is listing non electro-medical devices with South Africa’s Competent Authority on behalf of manufacturers before the authority’s August 2017 deadline, as well as acting as an Authorized Representative. ...

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  • Apr 24 2017
    70+ CLASS I DEVICES NOW EXEMPT FROM 510(K) REQUIREMENTS

    The US Food and Drug Administration (FDA) has identified a list of over 70 class I devices that are now exempt from premarket notification requirements....

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  • Apr 19 2017
    REGULATORY UPDATE: ETGAR MEDICAL INSTRUMENTS

    USA: Etgar Medical Instruments' Dental Implants System was approved for sale with LICENSALE.COM®. ...

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  • Apr 19 2017
    RUSSIAN REGULATORS ISSUE REQUIREMENTS FOR IVD & MEDICAL DEVICE TECHNICAL FILE SUBMISSIONS

    The Russian Ministry of Health has introduced a new regulation that clarifies the official requirements for in vitro diagnostic (IVD) & medical device technical file submissions. ...

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  • Apr 6 2017
    REMINDER: ARAZY GROUP CAN HELP REGISTER MEDICAL DEVICES IN BRAZIL IN JUST 7-9 MONTHS

    As a member of ABIMED (the Brazilian Association of Industry of High Technology Medical and Hospital Equipments, Products and Suppliers), Arazy Group can help medical device manufacturers register their products in Brazil within seven to nine months. ...

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