Arazy Group Blogs and Case Studies 

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...

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...

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 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....

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...

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...

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...

Q1: What are the main changes to registration in Malaysia? JG: Currently, medical device registration is under a voluntary scheme. Under the Medical Device Regulations 2012, medical devices will have to undergo a conformity assessment before they are released into the...