Arazy Group Blogs and Case Studies

Country at a glance: Malaysia

by arazygroup | Jun 25, 2014

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...

5 questions & answers: finding success in china

by arazygroup | Jan 29, 2014

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...

Country at a glance: Vietnam

by arazygroup | Dec 9, 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...

Country at a glance: South Korea

by arazygroup | 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...

The rewards of expert regulatory navigation in Kazakhstan

by arazygroup | Sep 24, 2013

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...

Country at a glance: Thailand

by arazygroup | Apr 24, 2013

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....

Case study: finding the golden mean for class iii medical device registration with the USA FDA

by arazygroup | Apr 11, 2013

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...

5 questions & answers: recent requirements for medical devices in the USA

by arazygroup | Mar 23, 2013

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...

Country at a glance: Russia

by arazygroup | Mar 21, 2013

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...