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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

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

A country of 15 million people, Cambodia’s 2013 GDP was about $15.5 billion with growth around 7%. As the Cambodian economy develops, healthcare spending has been expanding throughout the country. Though still smaller and more difficult to do business in than many... Read More

Sourcing medical devices in Asia has become a common practice as more companies are taking advantage of the lower overhead, lower labor costs and increasing technical capabilities available in the Asian countries. Medical device companies can buy and manufacture a wide array... Read More

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

It is projected that infectious diseases in South and Southeast Asia will increase in the future, as rapid economic growth has led to rising air travel and urbanization — with growing people-to-people and people-to-animal interactions. SARS, bird flu and swine flu are... Read More

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

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