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
台湾食品和药物管理局（TFDA）宣布了提高医疗器械注册申请收费，生效日期为2015年7月1日。 I类医疗器械的申请费用略有下降，而对于II类和III类医疗器械的申请费用每项都增加几百美元。第II类医疗器械现在几乎需要1000美元用于注册申请，III类医疗器械将花费大约为1400美元。创新医疗器械的申请费用将更高。 此外，医疗器械进口许可的申请，产品许可证的延续申请，现有医疗器械注册和许可的变更的费用也有所增加 – 如改变产品适应症或生产产地。 尽管有这些小的费用增加，台湾医疗器械注册申请的政府收费，和中国大陆的注册申请费用相比仅为一个零头。 Read More
The Taiwan Food and Drug Administration (TFDA) has announced a registration fee increase that will be effective as of July 1, 2015. Registration fees for Class I devices will decrease slightly, while fees for Class II and III devices will increase by... 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
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
台湾食品和药物管理局（TFDA）日前宣布，计划从2015年7月1日起修改医疗器械上市许可 审批制度。申请人需要提交质量体系文件（QSD）核准通知书作为初始上市许可申请文件的一 部分。目前，TFDA有时允许申请人初次申请文件提交后几个月后提交这些QSD信件。 行政文件的初步审查后，TFDA将对高风险的医疗器械的临床前试验文件和出厂质量控制文件进行评估。安全性、质量和性能将会被特别审查。注册申请费也将上调。 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
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
The developing world is experiencing more Western diseases as they consume more Western products such as fast food, leading to a rise in the cardiology, orthopedics, and cancer rates. This means that the developing world is seeing a growing demand for devices... Read More