Arazy Group Blogs and Case Studies
5 things to know about upcoming FDA guided requirements
Q1: What is the GUDID? RK: The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the U.S. Food and Drug Administration (US FDA) that serves as a reference catalog for every device with an identifier. Identifiers are...
Country at a glance: Tajikistan
Located in Central Asia, the Republic of Tajikistan is a mountainous, landlocked country, bordered by Afghanistan, Uzbekistan, Kyrgyzstan and China. A presidential republic comprising four provinces, it spans over 140 000 km2 and is home to more than 8 million people....
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...
Country 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...
5 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...
Country 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...
Country 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...
The 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...
Country 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....
Case 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...
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