此流程图阐明了中国台湾每个医疗器械分类的TFDA认证审批流程,可在法规事务管理平台(RAMS)下载。

Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process.

Classification is arguably one of the most important steps in the US FDA medical device approval process. Understanding how the US FDA classifies devices and the tools available to you is critical for identifying the proper regulatory pathway in the United States.

Download our white paper on European Technical Files For CE Marking Of Medical Devices

Saudi Arabia is one of the world's top 20 global economies. It has close to 29 million people, and about 95% of its market is supplied by imports. Interested in entering this prime market for medical devices? This short video provides an overview of how Saudi Arabia regulates medical devices.

此流程图阐释了哥斯达黎加每个医疗器械分类的MOH注册审批流程,可在法规事务管理平台(RAMS)下载。

此流程图阐明了新加坡每个医疗器械分类的HSA注册和认证审批流程,可在法规事务管理平台(RAMS)下载。

 

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