With more than 600 billion people and a combined GDP of $2.3 trillion, the ten nations that make up the Association of Southeast Asian Nations (ASEAN) are already experiencing dramatic economic growth. This is especially true of the medical device market, which... Read More
Malaysia might not be the first country that comes to mind when medical device manufacturers want to export their products to Asia. However, the nation of 28.8 million has a medical device market of more than $1 billion, which is expected to... Read More
Malaysia will see its medical device market grow from just over US $1 billion to $3.8 billion by 2020, according to a new report. Malaysia’s Ministry of Health (MOH) says that better access to healthcare and an aging population, along with new... Read More
ASEAN (Association of Southeast Asian Nations) recently released a draft of the ASEAN Medical Device Directive (AMDD) for comments in August 2012. This draft aims to enhance and harmonize medical device regulations among member countries. ASEAN plans to implement the Directive by... Read More
The Association of Southeast Asian Nations (ASEAN) is set to introduce the ASEAN Medical Devices Directive (AMDD), a uniform set of regulations that will cover all 10 of its member states. The AMDD will be written based on the Global Harmonization Task... Read More
Recently, the Malaysian government has been trying to implement stricter regulatory control of imported pharmaceutical products. Beginning July 2012, all drugs imported into Malaysia will be required to undergo a strict licensing scheme before entering the country. Companies who wish to import... Read More
Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Bureau (NPCB), the pharmaceutical regulatory body within the Malay Ministry of Health (MOH) recently signed a memorandum of understanding (MOU) on pharmaceutical regulatory matters. This is the first health sector MOU signed... Read More
In the past, Malaysia has not had any medical device regulations, including product registration. In March 2012, Malaysia’s Ministry of Health (MOH) cleared legislation for two acts that will establish a new regulatory agency for medical devices and require mandatory registration of... Read More
The Malaysian drug market, currently valued at about $1.6 billion, is still relatively small but grown quickly. The pharmaceutical market is set to grow at about 7% between 2012 and 2014. Original branded drug sales, through retail pharmacies, comprised over 15% of... Read More
On November 12, 2011, the United States and eight other countries jointly announced the outline for a new Trans-Pacific Partnership (TPP) on trade and investment. This landmark partnership aims to coordinate economic activity, regulatory standards, and tariffs in all trade areas. In... Read More