Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and the Americas

Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS.

Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms. Learn how prepare the necessary documents and register your product with the Chinese regulatory authorities. As a special administrative region of China, Hong Kong has its own medical device regulations, separate from the mainland. While Hong Kong had little legislative control over the import of medical devices in the past, recent changes to Hong Kong’s medical device registration system have led to stricter requirements. The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered. Registration of medical devices in Japan is complicated, costly, and will generally take between 1-3 years depending on the device classification. In some cases, Japanese regulators require clinical trials in Japan to be conducted, and the costs of these trials can be very high. Product registration in Japan needs to be pursued carefully and only after determining that there is a strong market demand for your product. South Korea’s medical regulatory system can be complicated for Western medical device manufacturers due to its increasingly strict requirements and Korea’s unique business culture. Learn the process and determine the necessary documents and submitting your application to the Singaporean medical device regulatory authorities. The complexity level of Taiwan’s medical device registration process is comparable to that of Japan’s and China’s registration processes, though somewhat simpler. In certain cases, U.S. or EU approvals can be substituted for local requirements. In addition, Taiwan’s government has recently been overhauling the approval system to improve its efficiency. Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA).