Multiple countries in the APAC region have been experiencing outbreaks of preventable diseases in 2016. The number of Singapore’s measles cases doubled in the first half of 2016 compared to the same time period in 2015, while Malaysia’s tripled from 2015 to... Read More
The CFDA has required many class II and III medical device distributors to self-assess their facilities by July 15, 2016. This policy was previously applied to drug distributors in order to eliminate bad distributors and has now been expanded to include medical... Read More
Unlike the other Asian countries, in Indonesia, an independent, third party entity in-country cannot register foreign devices. According to Indonesian law, devices can be registered via the foreign company’s Indonesian distributor or the foreign company’s subsidiary operation in Indonesia. To get around... Read More
Vietnam’s over-the-counter (OTC) drug market presents great opportunities for multinational pharmaceutical companies. The growth in Vietnam’s OTC market is being driven by rising household income as well as increased interest in personal health and well-being. Drug categories that show a lot of... Read More
This article was also published on MedTech Intelligence. All medical device companies that are interested in the Japanese medical market need to determine the most effective way to either enter Japan or expand their presence there. However, Western device executives often try... Read More
2015年4月30日，香港公布了医疗器械分销商新的自愿登记制度。分销商提交的登记申请将可在香港医疗器械管理办公室为设备制造商和分销商主办的在线门户网站上搜索到。该网站上登录的医疗设备分销商信息，将使外国医疗器械公司能够更容易地搜索到香港有信誉的经销商。 为了获得资格，设备经销商必须在香港设立当地办事处。另外，经销商必须建立适当的管理程序，以正确地保留销售记录，存储和运送医疗器械，管理产品警报和召回，管理报告不良事件和投诉，跟踪高风险设备，并为所分销的产品提供维修服务。 I类医疗器械的经销商将不包括在新的系统中。 Read More
On April 30, 2015, Hong Kong announced a new voluntary registration system for medical device distributors. Distributors who apply for registration will be listed on a searchable online portal of device manufacturers and distributors, hosted by Hong Kong’s Medical Device Control Office.... Read More
This presentation covers the latest updates on medical device business and regulatory issues in China. View the presentation to learn more about Chinese market trends, distributor search, product registration, manufacturing, and more. To view these presentation slides, please click on 2015 China Medical... Read More
This presentation provides an overview of the Asian medical device markets and covers important regulatory issues for specific Asian countries, including China, Japan, India, Thailand, and Vietnam. To view these presentation slides, please click on Asia Medical Device Markets Overview Presentation ... Read More
Good Distributors: the Key to Successfully Selling Medical Devices in Japan and China Read More