In late June 2014, the FDA released a draft guidance entitled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. The guidance announced that these types of systems and devices would no longer need to comply with some... Read More
On June 1, 2014, China's amended "Regulations on the Supervision and Administration of Medical Devices" went into effect. Class I medical devices -- domestic and imported -- no longer need to be registered with the China Food and Drug Administration (CFDA). Instead,... Read More
2014年6月1日，中国的修订后的"医疗器械的监督管理办法"正式生效。国产和进口第一类医疗器械不再需要在中国食品药品监督管理局（CFDA）注册。然而，第一类医疗器械必须通知当地的食品药品监督管理局。外国医疗器械制造商应指定一名中国代表代理人提交有关产品的注册材料。 Read More
The Indian medical device market is worth about $4.3 billion dollars. It is expected to grow to about $12 billion dollars by 2022. More and more Western device companies are registering their products in India. For registration renewals, the DCGI is now... Read More
As noted in last month's eNewsletter, China has been working on significant revisions to its medical device laws. On March 31, 2014, the Chinese government released amendments to the "Regulations on the Supervision and Administration of Medical Devices." Read More
上个月我公司的电子通讯报道，近些年中国一直致力于修订其医疗器械法。 2014年3月31日，中国政府发布了重新修订的"医疗器械监督管理管理条例"，该法规将于2014年6月1日生效。本年度，中国食品药品监督管理局（CFDA）还将进一步颁布30多个的补充实施细则。 Read More
On March 31, 2014, the Chinese government released a revised version of the "Regulations on the Supervision and Administration of Medical Devices." These regulations were approved by the State Council on February 13, 2014 and will officially go into effect June 1,... 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
The pharmaceutical market in Thailand had a 2013 value of more than $4.5 billion, almost the same size as the Taiwan market. Already the second largest in Southeast Asia (behind Indonesia). the Thai drug market is projected to double by 2020. Read More
On February 13, 2014, the Chinese State Council approved a revised Medical Devices Regulations, which was first adopted in 2000. The revision of the bill started in 2006, with a draft submitted to the State Council in early 2008. The updated regulation... Read More