Established by the Chairman, John Hsuan, 8 years ago, HKBio has delved into the regulatory services and contract design and manufacturing services for almost a decade. In 2021, HKBio had a record-breaking year due to the rapid growth in Taiwanese corporate rapid testing needs and sales growth in China, achieving more than 6 fold annual revenue growth and quarterly break-even…
Medical device design and development are highly technical and specialized. It is even more challenging for an early stage medical device startup to have the necessary resources to build an end-to-end manufacturing facility, from small scale prototypes to large scale mass production, not to mention the cost of clinical trial and patent maintenance. This is exactly the reason why medical…
A few decades ago, medical device OEMs single-handedly developed and manufactured their medical innovations. The advantage of this kind of operation is the ability to have complete control over design and development, small pilot production, and large scale mass production. However, a large-scale ISO13485 compliant GMP manufacturing facility represents an enormous capital commitment.
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…
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 bytwo 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.
“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…
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.
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…
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…
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…