Medical Device Registration and Approval Process for the Pacific Rim (including India, Japan, China, Singapore, Australia, Taiwan, Hong Kong, and other locations)

    Classification systems differ from that of the United States or European Union in select countries
    Medical devices are classified depending on their risk level
    Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements
    Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia
    The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear.
    In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy.
    And Much More...