Medtech Service Provider HuKui Bio raised US$5.5M for US market expansion

The medtech service provider Hukui Bio (互貴興業) announced that it has raised US$5.5 million in Series C funding, led by Yellowstone Holding AG from Switzerland, totalling US$11.8M funding to date.

HuKui Bio will collaborate with venture capital funds in the Bay area, in addition to the biomedical innovation clusters and accelerators in Europe and the US. The New Business Department and the US subsidiary in the Bay area were founded at the beginning of 2021, with the onboarding of Dr IC Jan (詹益鑑) as its Chief Strategy Officer.

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“Made in China” is no longer attractive due to the U.S.-China trade war, suggesting that Taiwan’s CDMO industry for electronic medical devices is going to be more lucrative

A few days ago, I had visited Hukui Biotechnology Co., Ltd. (Hukui Bio) which was founded by John Hsuan with Michael Kuo, the current CEO. We talked about the latest development in the global electronic medical devices market and the evolution of professional electronic medical devices contract development and manufacturing organization (CDMO) industry since the US-China trade war. In recent years, Taiwan has been actively investing in the integration of biomedical and bio-ICT industries. New advancements and changes in CDMO industry will bring forth both major business opportunities and challenges, and it is worth sharing with everybody in this column.

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Cymmetrik and HUKUI Tech Work Together to Take AcuSense BioMedical Entering China Market

“Blood Leakage Detection System”, developed by AcuSense BioMedical Technology Corp. (AcuSense), is a specific medical device designed for kidney disease patient to reduce the risk of dialysis treatment. Through the cooperation with HUKUI Tech, the subsidy of Hukui Biotechnology Co., Ltd., AcuSense is going to expand its business to China. HUKUI Tech integrates product authorization, registration, production and distribution as a CDMO service. The CDMO service is a total solution provided by HUKUI Tech for those companies who are interested in marketing their new developed device. Without factory building by itself, AcuSense could speed up product launching schedule because of cost and time saving. It will help the product time on market.

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HUKUI Bio is Integrating its Network and Arranging Resource for Novel Coronavirus (COVID-19) Diagnostic Kit Supply Chain

In 2020, the epidemic of COVID-19 has spread in the whole world, and COVID-19 diagnostic kit is definitely a purchasing point from the beginning. HUKUI Bio has been authorized by two Taiwan nucleic acid diagnostic kit factories to begin providing COVID-19 diagnostic kit for Europe, ASEAN and South America markets, hoping to satisfy their local medical resources.

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Notes for Registration in China

What are the central authorities in charge of medical devices in various countries? United States  Food and Drug Administration (FDA) Attached to United States Department of Health, Education, and Welfare, is in charge of the administration of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies throughout the country. Taiwan  Taiwan Food…

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Clinical Guidelines in China

Are clinical trials necessary for medical devices to enter China? According to the 2018 announcement on the latest “Catalogue of medical devices exempted from clinical trials” (No. 94, 2018) and “Catalogue of IVD reagents exempted from clinical trials”, when the product description conforms to the medical devices or IVD reagents of the specification on the…

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Policy Guidelines in China

What are the norms for setting up a medical device factory in China? Good Manufacturing Practice for Medical Devices and YY0287-2017-Medical Devices-Quality Management Systems-Requirements for regulatory purposes / ISO 13485:2016 need to be followed. What is the current situation of centralized procurement of medical consumables? In March 2018, China changed the National Health and Family…

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HUKUI Bio Has Obtained Its First In Vitro Diagnostic Device License in China

HuKui Biotechnology Co., Ltd.(HUKUI Bio) announced that its wholly-owned subsidiary HuKui Technology Co., Ltd.(HUKUI Tech), has officially acquired the Class II Medical Device Registration License from Chongqing Municipal Drug Administration in China for two products: blood glucose test strip and uric acid test strip, on January 8th. It is the first time a manufacturer obtaining…

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