Taiwan’s New TCP III in Effect as of January 1, 2022
The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Eric is the General Manager of Asia Actual in Hong Kong, bringing 20 years of regional sales and regulatory experience and a passion for supporting medical device companies with innovative market entry solutions. In 2013, Eric founded Veecare Asia Limited to assist medical device companies with regulatory documentation, quality system implementation and device testing. Prior to establishing Veecare, Eric was global head of regulatory services for the Life Sciences Division of Underwriters Laboratories (UL) and was responsible for establishing the medical device regulatory consulting division to provide regulatory and testing consultancy for food and medical manufacturers. Prior to UL, Eric held key business development positions with 3M, Bristol-Myers-Squibb, Roche Diagnostic and Wyeth.
Eric holds an MBA and BA degree in Business Studies from the City University of Hong Kong. He speaks Cantonese and Mandarin, holds a professional diploma in diagnostic radiology from Hong Kong Polytechnic University and is ISO 13485 Lead Auditor certified.
The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications
Hong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.
The Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice has been in effect since May 1st, 2021.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
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