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  • COUNTRY AT A GLANCE: VIETNAM

    Posted on Dec 09, 2013
    The Socialist Republic of Vietnam is a country of over 90 million people and is located on the South China Sea in Southeast Asia, bordering China, Cambodia, and Laos. Since 2000, Vietnam has experienced incredible growth and has been ranked with the highest Global Growth Generators Index among 11 major economies earmarked for investment opportunities by Citigroup.

    Healthcare spending in Vietnam is weighed toward the private sector (at 61.3% of total expenditures in 2012) due to a poor level of care by the public health system, which is currently the focus of international aid and grants. As a result, hundreds of thousands of Vietnamese travel for medical care... Continue reading

  • COUNTRY AT A GLANCE: SOUTH KOREA

    Posted on Nov 27, 2013
    The Republic of Korea, a country with over 50 million people situated in the Korean Peninsula extending from mainland Asia to the east, borders the coasts of the Yellow Sea, East Sea, the Korea Strait, and the East China Sea. Its geography ranges from high mountain ranges and hills to coastal plains, river basins, and valleys to approximately three thousand islands. South Korea is a presidential republic based in the capital, Seoul, which is home to 10 million people making it one of the largest cities in the world. Seoul is a highly advanced technology centre and economic powerhouse with one of the highest standards of the living in the world. It hosts the sixth largest number of Fortune Global 500 companies in the world.

    59% of healthcare in South Korea is funded by the public sector with one of the highest health care expenditures in Asia and a public health insurance system. Healthcare costs are rising as the population ages and the average age nears 40, spurring... Continue reading
  • COUNTRY AT A GLANCE: SOUTH AFRICA

    Posted on Oct 24, 2013
    The Republic of South Africa, located on the coasts of the Atlantic and Indian Oceans at the southern end of the continent, is a constitutional parliamentary republic with a population reaching 53 million in 2013. The World Bank rates South Africa as an upper-middle income emerging economy and it is currently the largest and most developed economy on the continent of Africa with active sectors in mining, agriculture, energy, telecommunications, real estate, tourism, and more.

    While poverty and unemployment remain statistically high (each about 25% of the population according to some estimates), GDP for 2013 is estimated at $608.804 billion (PPP), placing it in the top 30 largest economies in the world. GDP also grew by... Continue reading
  • 3 WAYS MEDTECH REGISTRATION IN BRAZIL IS IMPROVING

    Posted on Oct 24, 2013
    Changes to regulations in Brazil are making room for major progress in easing medical device registration for high-risk devices. Currently, Brazil has the 7th largest economy in the world and the largest medical device market in South America, which is valued at USD $5,981.9 million and expected to reach USD $8 billion in revenue this year.

    Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária or ANVISA) has two tracks for medical device registration: cadastro and registro. The cadastro process is implemented for lower-risk devices, under which most Class I and II products are registered (excepting a published list of specific device types), and registration is usually completed within four to six months. Device registered via registro typically belong to higher-risk classes and regulatory approval can take as long as 24-30 months to obtain. While there are many attractions to the Brazilian market, medical device manufacturers with products that must go through the registro system have faced sometimes-insurmountable challenges when attempting to obtain... Continue reading
  • JOB POSTING: TECHNICAL SALES REPRESENTATIVE

    Posted on Oct 23, 2013
    Responsible for all sales activities related to the promotion of Licensale.com in assigned accounts within specified region(s). Manage quality and consistency of product and service delivery. From time to time, engage in specific marketing activities as related to cultivation and development of new leads (i.e. webinars, trade shows, etc.). Continue reading
  • 5 QUESTIONS & ANSWERS: CHANGING REGULATIONS IN THE DOMINICAN REPUBLIC

    Posted on Oct 09, 2013
    Recently, previous changes to the Dominican Republic’s policy for the sale and marketing of medical devices in their country began to take effect. In April 2011 and August 2012, the list of requirements and timeframes associated with obtaining a license were established and published by CGDF. Certain types of medical devices will have to go through a registration... Continue reading
  • COUNTRY AT A GLANCE: JORDAN

    Posted on Oct 09, 2013
    The Hashemite Kingdom of Jordan is a constitutional monarchy situated in the Middle East on the Jordan River, the Dead Sea, and the Gulf of Aqaba. In 2010, the nearly 90 000 km2 country was ranked as the 19th most expensive country in the world to live for its 6.5 million population. Amman, the capital of Jordan, has been recognized as one of the top 10 best cities in the world to launch a tech start-up by Rachid Sefraoui, the founder of Finaventures, in 2012.

    Reputed for its quality health care system, Jordan has been a center for medical tourism for over forty years, resulting in over USD $1 billion in revenue in 2010 from 250 000 patients from 102 countries. The World Bank rated Jordan as the fifth medical tourism destination in the world. In recent years, new public and private hospitals have... Continue reading
  • COUNTRY AT A GLANCE: MACEDONIA

    Posted on Sep 24, 2013
    The mountainous Republic of Macedonia was formed in 1991 following the fall and separation of Yugoslavia. With just over two million people, the parliamentary democracy is located in Southeastern Europe and aspires to membership in the European Union. Macedonia was officially recognized as an EU Candidate State in 2005. At this time, ascension talks have... Continue reading
  • CASE STUDY: THE REWARDS OF EXPERT REGULATORY NAVIGATION IN KAZAKHSTAN

    Posted on Sep 24, 2013
    The Republic of Kazakhstan is one of the world’s largest countries with a population of over 16 million people. The quickly growing economy in Kazakhstan has seen increased government spending in the health care sector since 2005, though regulations are undergoing changes as the Ministry of Health aims to improve the quality of health care. In 2013, Arazy Group initiated registration for over twenty medical devices in Kazakhstan from manufacturers in Germany, the Netherlands, Sweden, the United Kingdom, and the United States. The registration process in Kazakhstan offers two main challenges. Firstly, Kazakhstan requires that... Continue reading
  • COUNTRY AT A GLANCE: COLOMBIA

    Posted on Jul 31, 2013
    From the heights of the Andes to the rainforest of the Amazon and the coasts of the Pacific Ocean and Caribbean Sea, The Republic of Colombia is one of the largest countries in South America. With 48 million people, its economy is ranked the third largest on the continent and the 28th highest GDP in the world.

    Sweeping health care reform in the 1990s that pledged universal health coverage to Colombians are still underway, with approximately 80% of Colombians... Continue reading
latest news
  • 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....

    Read More
  • 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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  • Apr 4 2017
    ARAZY GROUP OFFERS QMS UPGRADE TO ISO 13485:2016 STANDARD

    In line with its commitment to making safe and effective IVD and medical devices available worldwide, regulatory affairs firm Arazy Group Consultants Inc. is assisting MedTech manufacturers in meeting the deadline to upgrade their quality management syste...

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