Articles

Browse our regulatory articles below or search through our archive.

 


 

  • 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
  • DISCOVER REGULATORY INNOVATION WITH LICENSALE.COM IN 2014

    Posted on Dec 14, 2013
    2013 was a year of heightened challenges for MedTech; between a changing healthcare environment in core markets and the rise of disruptive technologies like 3D printing and mHealth, the industry is demanding innovation and change from all players. Among the challenges faced, medical device regulations were high on the list. This year, MD+DI reported that, "A majority (52%) of device professionals identified regulatory pressures as the most concerning issue they will face in the next five years."

    2013 is also the first full year that... Continue reading
  • 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
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