ASEAN Medical Device Regulatory Update
The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. Read More
The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. Read More
The pharmaceutical market in Malaysia is worth $3.2 billion, about three times the size of Singapore's market. It is growing rapidly, at a pace of 11 percent per year. As Malaysia's economy booms, spending on healthcare is up. The country's 28.9 million... Read More
According to a recent report by IMS Research, Asia will soon lead the world in market revenue growth for diagnostic cardiology devices. From now through 2016, revenue from such devices in Asia is set to more than double. World demand will grow... Read More
Of the worlds 371 million people diagnosed with diabetes, nearly 200 million live in Asia. According to the International Diabetes Federation (IDF), those numbers are set to climb dramatically. By 2030, it is estimated that 522 million people worldwide will have diabetes,... Read More
In a globalized world, many international medical device companies choose to source or manufacture their devices in Asia. Relatively low labor costs, low overhead costs and improving technical capabilities are all reasons for making the move. Labor costs have risen significantly in... Read More
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