China Releases New List of Standards for Medical Device Registration
The NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.
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.
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).
Beginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Starting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
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