China to Enact Medical Device Law
On August 28, 2024, China released a draft of the medical device law for public comment on significant regulatory changes.
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.
On August 28, 2024, China released a draft of the medical device law for public comment on significant regulatory changes.
On May 1, 2023, Hainan Province reaffirmed its special access program to for the importation of urgently needed drugs and medical devices.
In March of 2024, the CMDE added 25 devices to the “Guidelines for Deciding Whether to Conduct Clinical Trials on Medical Devices”.
The NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.
On July 4th, 2024, the Hong Kong Department of Health (DH) released an update on the upcoming enhancements to their procurement strategy concerning the registration of Applicable Medical Devices (AMDs).
On June 14th, 2024, the TGA made some amendments (2024 Measures No.2) to Australia’s medical device regulations.
On June 5th, Hong Kong’s Department of Health (DH) announced plans for the establishment of the Centre for Medical Products Regulation (CMPR).
On May 9th, 2024, Australia’s Therapeutic Goods Administration (TGA) updated its guidance for AI Medical Devices and Machine Learning Medical Devices.
In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system, called Sakigake, which is meant to streamline the regulatory pathway for qualifying medical products.
Medical device consultation in Japan is a very involved but essential process in registering a medical device. A significant part of the regulatory process in Japan is consultation meetings with the Pharmaceuticals and Medical Devices Agency (PMDA).
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
116 Changi Road, #04-05