Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
Over a 15 year career in the medical device industry, Albert has been responsible for new technology commercialization into Asian markets for large companies such as GE, Medtronic and Philips.
Albert joined Asia Actual to share his knowledge and experience with dynamic clientele covering market assessments, market access, reimbursement, KOL identification and development, trade finance, and regulatory compliance. He brings an infectious positive outlook and impressive seasoned professionalism to projects. Prior to transitioning to medical devices, Albert enjoyed a successful career in the petrochemical industry.
Albert has an undergraduate degree from Diponegoro University in Chemical Engineering and an MBA from the University of Birmingham with specialization in Strategic Management and Finance. A native of Indonesia, Albert has been living in Singapore for over 12 years and speaks fluent Bahasa Indonesia and English. Away from work, Albert is an engaged husband and father, and can often be found on the tennis court.
An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.
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