Arazy Group Blogs and Case Studies
Country at a glance: Australia
The Commonwealth of Australia is one of the largest countries in the world, comprising of one large landmass and several small islands located in the Pacific and Indian oceans. Its massive size is home to a variety of landscapes and climates, with most of the...
read moreCountry at a glance: Malaysia
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...
read more5 questions & answers: finding success in china
Q1: What are some of the main trends concerning product registration in China? EC: In 2013, I have seen the market continue to increase at a high rate. The Chinese market is massive and willing to spend a lot on new medical technologies. There is especially a demand...
read moreCountry at a glance: Vietnam
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...
read moreCountry at a glance: South Korea
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...
read moreThe rewards of expert regulatory navigation in Kazakhstan
THE BACKGROUND 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...
read moreCountry at a glance: Thailand
The Kingdom of Thailand, a country with a population of well over 65 million people, acts as a regional hub in Southeast Asia. Along with countries like Malaysia and Indonesia, it is considered a relatively new hot spot for investment and sale of medical devices....
read moreCase study: finding the golden mean for class iii medical device registration with the USA FDA
BACKGROUND On October 1st, 2012, the USA FDA introduced MDUFA III (Medical Device User Fee Amendments), which implemented new regulations for the registration on medical devices. While it is expected that the FDA will revise regulations at the beginning of the fiscal...
read more5 questions & answers: recent requirements for medical devices in the USA
Q1: I am hearing about changes for the registration and listing of manufacturers with the FDA. How does this impact me? PB: On October 1st, 2012, all medical device manufacturers must report all proprietary names and combination products (device/biological...
read moreCountry at a glance: Russia
The Federation of Russia, spanning nine time zones and sharing borders with 16 countries, is one of the most resource-rich regions in the world. Ranked as the tenth highest economy according to GDP and sixth largest according to PPP, it is considered one of the...
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