China’s NMPA Begins Issuing Registration Certificates Electronically
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
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 October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.
Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”
Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.
In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.
Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
On June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.
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