About Bryan Gilburg
The focus of Bryan’s 20 years in the medical device industry has been to grow sales in Asian markets. Bryan founded Asia Actual in 2015, bringing together the most experienced, professional and results oriented consultants in the region to assist clients with their biggest sales challenges.
Prior to founding Asia Actual, Bryan was the Vice President of Business Development at Emergo Group responsible for establishing and growing the company’s regulatory consulting business in Asia. For 10 year prior to joining Emergo, Bryan provided consulting services related to market assessment, sale channel establishment and sales channel management in Asia and the US for a wide variety of medical device companies. Prior to his consulting career, Bryan managed Asia business for large multi-national medical device companies.
Bryan holds an MBA from the Kellogg School of Management and Hong Kong University of Science and Technology and a BA degree in economics and East Asian Studies from St. Lawrence University. He speaks Japanese and has lived, studied and worked extensively in Japan and China.
Entries by Bryan Gilburg
New Regulations in India Raise the Bar for Many IVD Devices
/in India, Latest Updates/by Bryan GilburgThe new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.
The Philippines FDA Streamlines Amendment Submission Process
/in Latest Updates, Philippines/by Bryan GilburgOn December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.
Philippines Implements New Customs Clearance Procedure for Radiation Devices
/in Latest Updates, Philippines/by Bryan GilburgRadiation-emitting medical devices such as X-ray machines, MRIs, linear accelerators and ultrasound scanners are now subject to a new customs clearance release procedure administered by the Philippine Food and Drug Administration (FDA)
Korea Announces Plans for Unique Device Identification (UDI) Requirements Starting in 2019
/in Latest Updates, South Korea/by Bryan GilburgThe Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.
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