Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
Diabetes cases are dramatically on the rise in countries throughout Asia. The financially privileged city-dwellers tend to be the ones who have been identified as diabetics. Causes include insufficient exercise, high fat diets that have increasingly incorporated fast food items, genetics and... Read More
In April 2010, various officials of the Drug Administration Agency, Ministry of Health, and drug companies met in Hanoi to have a discussion on the rising cost of drugs in Vietnam. In recent years, there has been growing public outcry against the... Read More
In Vietnam, it was recently discovered that a major US drug company was involved with Ho Chi Minh City (HCMC) doctors promoting two types of drugs in exchange for commission. These doctors allegedly accepted kickbacks to prescribe drugs made by Schering-Plough, which... Read More
Vietnam is currently attracting a great deal of foreign investment, especially from foreign medical device manufacturers that are relocating due to rising wages in coastal and southern China. American and European medical device makers dominate the market, but more and more global... Read More
On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... Read More
Vietnam has recently moved to enhance its medical device regulatory system. While imported medical devices do not need to be registered in Vietnam to be marketed, they do require an import license. First-time device imports that use a novel method of diagnosis... Read More
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
On June 24, 2008, Vietnam and the United States signed a memorandum of understanding (MOU) to enhance the safety of medical devices, drugs, food, and feed traded between the two nations. This MOU is a result of discussions between senior Vietnamese officials... Read More