By July 2014, almost all medical devices sold in Malaysia will require registration. In addition, all legal representatives of foreign medical device companies must have establishment licenses and certificates for Good Distribution Practices (GDPMD). Under the Medical Device Act 2012, those who... Read More
Malaysia’s Medical Device Authority (MDA) has released final guidelines for the registration of medical devices under the country’s 2012 Medical Device Act. According to the guidelines, all registrations should take place through MeDC@St, the MDA’s Medical Device Centralized Online Application System. An... Read More
In July 2013, Malaysia’s Medical Device Authority (MDA) issued its latest guidance on good distribution practices (GDP) for medical devices sold in Malaysia. This is an update of previous standards, which were released in draft form in November 2010. The new guidance... Read More
Together, the ten countries of the Association of Southeast Asian Nations (ASEAN) have a combined GDP of $2 trillion and a population of more than 600 million. Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Myanmar (Burma), Cambodia, Laos and Vietnam made up... 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