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.
China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.
On February 15th the Thai FDA published significant new guidance governing the classification, technical documentation requirements, fee schedule and transition plan for medical device registration. This much anticipated action harmonizes the Thailand’s Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2) with the ASEAN Medical Devices Directive.
A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.
The Chinese national government has established a special economic zone on Hainan Island with a focus on medical devices and wellness. Medical device manufacturers seeking sales growth in China should be aware of the Boao Hope City development particularly those with new and innovative devices.
The NMPA has continued to stay busy this year, releasing numerous guidance documents and updates to their regulatory requirements. Here are some of the most important updates from the last few months.
As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.
The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China
By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.
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