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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

Indonesia's pharmaceutical market is one of the fastest growing in Asia, expanding at an annual rate of 12.5 percent. It is currently worth $4.5 billion, about the same size as Taiwan's pharmaceutical market. But while Taiwan's economy is mature, Indonesia's is still... 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

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

As part of its recent campaign to modernize and expand its national healthcare system, Indonesia has implemented an e-registration system for medical devices. While the documentation requirements are much the same as other ASEAN countries (distribution license and letter of appointment for... Read More

The Indonesian government stepped up implementation of a multibillion dollar plan, proposed in late 2011, that would grant health insurance to all citizens beginning in 2014. Under the current system, called Jamkesmas, only 64% of the Indonesian population has health insurance. The... 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

Korea’s Food and Drug Administration (KFDA) and Indonesia’s National Agency of Drug and Food Control (NADFC) recently signed a memorandum of understanding (MOU) on safety and quality standards.  This is the first inter-country MOU signed by the Indonesian NADFC. Prior to this... Read More