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  • 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
  • 5 QUESTIONS & ANSWERS: THE FUTURE OF MEDTECH IN SUB-SAHARAN AFRICA

    Posted on Mar 06, 2014
    A Q&A with Adebiyi Ademeso, Regulatory Expert with Arazy Group in Nigeria, on trends, advantages, and challenges of the medical device market and regulatory landscape in Sub-Saharan Africa.

    Demand for healthcare in Sub-Saharan Africa is on the rise. Throughout the region, the quickly growing middle class is willing to pay for health care and increasingly, governments are allowing the private sector to expand in order to meet the demands. In fact, the International Finance Corporation (IFC), an arm of the World Bank, published a report in 2008 citing that the private sector in Sub-Saharan Africa accounts for 60% of health care expenditures and is critically important to the development of health care services throughout the continent. This is especially true in places like Nigeria, Ghana, and the Ivory Coast... Continue reading
  • COUNTRY AT A GLANCE: GHANA

    Posted on Mar 06, 2014
    The Republic of Ghana is located in West Africa on the coasts of the Atlantic Ocean and the Gulf of Guinea. It shares its borders with Burkina Faso, the Ivory Coast, and Togo. The constitutional republic, the first Sub-Saharan country to declare independence from colonialist powers in 1957, is populated by 25 million people.

    In 2013, Espicom estimated the medical device market in Ghana to be worth USD $94.9 million and expects it to grow to USD $173.4 million in 2018. In March 2013, Ghana released an updated guidance on the... Continue reading
  • JOB POSTING: PRODUCT BUSINESS DEVELOPER - PUBLIC SECTOR

    Posted on Feb 18, 2014
    We are seeking an experienced business developer to lead and execute a strategy of promoting our IT regulatory affairs management solutions to regulatory agencies in the public sector. Our target is governments, global health organizations, regulatory authorities, and notified bodies around the world. A successful candidate must be a polished professional skilled in developing new relationships with high-profile government officials, representatives of global health organizations, and industry influencers. They must be a prime revenue driver, with a focus on increasing top-line growth. Continue reading
  • JOB POSTING: PRODUCT COMPLIANCE SPECIALISTS

    Posted on Feb 18, 2014
    Advance your professional experience with a winning team at Arazy Group Consultants, Inc. We are a global RA/QA consulting organization with immediate openings for qualified consultants in the fields of... Continue reading
  • COUNTRY AT A GLANCE: ARGENTINA

    Posted on Feb 13, 2014
    The Argentine Republic is one of the largest countries in South America, located in the southern part of the continent on the coastline of the South Atlantic Ocean. The population of Argentina numbers over 41 million people, centered in the capital city of Buenos Aires. Buenos Aires, an autonomous port city among 23 provinces, is one of the largest metropolitan areas in the world and the base of nearly half the industries in the country.

    Most medical devices in Argentina are imported. In 2013, the medical device market in Argentina was valued at nearly USD $700 million, one of the largest in South America, and is expected by Espicom to grow over... Continue reading
  • 5 QUESTIONS & ANSWERS: JUST HOW FAST IS MEXICO'S FAST TRACK PROCESS?

    Posted on Feb 13, 2014
    A Q&A with Matias Valero, Regulatory Expert with Arazy Group in Latin America, on changes, advantages, and challenges of Mexico's fast-track for medical device registration. COFEPRIS has three processes for the registration of medical devices: the standard method, the fast-track option, and the recently-introduced... Continue reading
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