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  • 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
  • 5 QUESTIONS & ANSWERS: FINDING SUCCESS IN CHINA

    Posted on Jan 29, 2014
    A Q&A with Eva Chou, Regulatory Expert with Arazy Group in China, on trends and tips for successful registration of medical devices in China. The Chinese market is massive and willing to spend a lot on new medical technologies. There is especially a demand for foreign devices representing advanced technologies, even though these devices are typically more costly than their generic or more traditional counterparts... Continue reading
  • COUNTRY AT A GLANCE: UNITED ARAB EMIRATES

    Posted on Jan 29, 2014
    The United Arab Emirates (UAE) is a federation of seven emirates (Abu Dhabi, Ajman, Dubai, Fujairah, Ras al-Khaimah, Sharjah, and Umm al-Quwain) in the Arabian Peninsula on the Persian Gulf, sharing coastline with the Strait of Hormuz, one of the world’s most important international trade routes. With a population exceeding nine million, the UAE stands out in the world as an international country where less than one fifth of its people born in the UAE.

    Healthcare spending in the economic region, referred to as the Gulf Cooperation Council (GCC), is predicted to triple by 2018 to over... Continue reading
  • COUNTRY AT A GLANCE: PERU

    Posted on Jan 08, 2014
    The Republic of Peru is located on the Pacific coast of South America, sharing borders with five countries including Brazil and Chile. With a population of nearly 30.5 million people, the democratic republic spans large portions of the Andes mountains, the Amazon rainforest, and arid coastlands. Its capital city, Lima, is the fifth largest city in South America with over 9 million residents and is home to the Lima Stock Exchange.

    Espicom estimates the medical device market in Peru to be USD $321.6 million in 2013 (or USD $10.7 per capita). As the economic market remains strong, health insurance programs... Continue reading
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  • Jul 17 2017
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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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