South Korea’s Ministry of Food and Drug Safety (MFDS) has announced additional high risk medical device product types that must be tracked post-registration. Since late last year, importers of certain high-risk implantable devices have been required to report on the status of... Read More
By June 30, 2015, foreign medical device manufacturer products must be on Malaysia’s transition list to be sold in Malaysia. In addition, in February of 2015, the Malaysia Medical Device Authority (MDA) published a draft guidance for a proposed system of post-market... Read More
The Taiwan Food and Drug Administration (TFDA) recently announced plans to change the country’s medical device marketing authorization approval system starting July 1, 2015. Applicants will need to submit Quality System Documentation (QSD) Approval letters as part of the initial marketing authorization... Read More
Mandatory Device Registration Coming Soon to Malaysia Read More
China's Pharmaceutical Market Reforms Read More
China Releases Biosimilar Guidelines Read More
马来西亚医疗器械注册马上开始! Read More
印度将对医疗器械不良反应进行监测 Read More
中国颁布生物类似药指导原则 Read More