This article was also published on MedTech Intelligence. Out of the 410 million people worldwide who have been diagnosed with diabetes as of 2014, more than 60% of the cases were from Asia, according to the International Diabetes Federation (IDF). Last year China... Read More
This article was also published on ORTHOWORLD BONEZONE. Why Orthopaedics Will Grow in Asia Orthopaedics remains an attractive and growing market, especially in Asia. Multiple factors contribute to the growth of the orthopaedic market in this region. First, the quickly-growing elderly population... Read More
The Asia-Pacific market (including China, Japan, and India) for diabetes-related devices is predicted to reach between US$7 and US$10 billion by the end of the decade. Growth in the glucose monitoring device market is particularly strong, with growth rates estimated at 15%... Read More
This article was also published on MedTech Intelligence As one of the fastest developing regions in the world, Asia’s strong economic growth, coupled with its burgeoning middle class, has led to greater demand for better healthcare service. Over the next five years,... 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
越来越多的西方医疗器械和诊断公司都选择在亚洲国家开展临床试验。这一趋势预计将在未来十年持续增长。西方公司尤其会在日本、中国、韩国和新加坡增加临床试验的操作。 同时，越来越多的医疗器械的临床试验也正在东南亚进行。东盟（ASEAN）10个国家总人口约6.2亿, GDP总和约2500亿美元。东盟国家目前正在协调他们的医疗器械和药品监管框架，这将使多中心的临床试验更容易在东南亚开展。 为什么西方的医疗器械公司都选择在亚洲开展他们的临床试验，原因有很多种。与美国或欧洲相比，在亚洲开展临床试验公司最多可节省50％的费用。亚洲国家通常可以提供较多的病人，且临床试验患者的流失率低，以及可以找到更多初次接受治疗的人群。此外，许多亚洲国家正在不断升级自己的规定，以符合临床试验的国际标准 -美国和欧洲的监管机构也越来越多愿意接受来自亚洲的临床试验数据。 然而，西方的医疗器械公司也在进行中的亚洲临床试验中面临挑战。这些挑战包括语言上的差异，知识产权保护，以及不同的监管框架和要求。此外，这种在亚洲临床试验数目的增长不包括印度，印度的临床试验已经看到了80％的骤降。 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
More and more Western medical device and diagnostics firms are choosing to conduct clinical trials in Asian countries. This trend is expected to grow over the next decade. Western companies are in particular expanding clinical trial operations to Japan, China, South Korea,... Read More
This article was also published on Medical Device Summit An increasing number of Western device companies have been acquiring or entering into joint ventures with Asian medical firms. Acquisitions and joint ventures with Asian medical companies can provide many advantages for Western... 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