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Medical Device Regulatory Updates in Malaysia

The past several months have seen several announcements by the Malaysian Medical Device Authority (MDA). First launched in mid-2013, the online Medical Device Centralized Application System (MEDCAST) was expanded to support in vitro diagnostic (IVD) device submissions in May 2014. The MDA... Read More

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马来西亚的医疗器械法规更新

在过去的几个月,马来西亚医疗器械管理局(MDA)发布了几条消息。2013年年中,首次网上推出,医疗器械集中式应用系统(MEDCAST)。于2014年5 月支持在体外诊断(IVD)仪器的申请。 MDA公布了体外诊断试剂的12步注册程序。 另外2014年5月,MDA的颁布5项新政策,进一步落实医疗器械法: Read More

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Malaysia Pharmaceutical Market Update 2014

Malaysia's pharmaceutical market is valued at over $3 billion and has a double-digit annual growth rate. Thanks to an increasingly affluent and expanding middle class, an aging population, urbanization and higher quality healthcare and medicines, Malaysians spent about $400 per person on... Read More

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Contract Research Organizations in Asia Report 2014

This report on Asian CROs provides a comprehensive list of contract research organizations in Asia. The countries covered include: Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia, Thailand and Vietnam. Included for each CRO are contact information, description of... Read More

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2014 ASEAN Medical Device Update

The ten nations that make up the Association of Southeast Asian Nations (ASEAN) -- Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- together have a population of over 610 million, almost twice the population of the U.S.... Read More

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Malaysia Issues Guidelines for Medical Device Registration

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