印度尼西亚发布医疗器械配件修订规定,引入电子注册系统
印度尼西亚引入医疗器械电子注册系统,此举是为其于2015年1月融入东南亚国家联盟(ASEAN)法规体系做准备。同时对于医疗器械及相关附件的海关申报也出台了明确规定。 Read More
印度尼西亚引入医疗器械电子注册系统,此举是为其于2015年1月融入东南亚国家联盟(ASEAN)法规体系做准备。同时对于医疗器械及相关附件的海关申报也出台了明确规定。 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
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