Arazy Group Blogs and Case Studies
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...
5 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...
Country 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...
Country at a glance: 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...
5 questions & answers: medical device registration in Malaysia
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...
Country at a glance: Singapore
The Republic of Singapore, a densely populated country of five million people, has the third highest per capita income in the world. Consistently, Singapore ranks at the top of international lists profiling investment potential, ease of doing business, open economies,...
Arazy Group – One World Process
Inquiry Form
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.
Recent Comments