提供您產品註冊、臨床試驗、 當地代理人與法規調研服務。

理工科技由張印本博士於2000年成立,是亞洲醫療器材的法規諮詢服務與臨床試驗(CRO)公司。自創立開始,理工科技就以誠信正直、多元背景、持續學習、團隊合作的企業文化,經營跨領域的專業團隊,並提供客戶有品質、有效率與一站式的法規諮詢與臨床試驗服務。

我們藉由與每個客戶所建立的堅強夥伴關係,創造了許多優質產品成功進入亞洲新興市場的案例,並在提供法規諮詢品質與解決效率上已建立聲譽。

理工科技 即時消息

Qualtech Will Attend the 46th Beijing International Medical Devices Exhibition​ - September 2025
2025-08-25

AUSTRALIA: Beauty Obsession in AUSTRALIA: Cosmetic Procedures on the Rise – JULY/AUGUST 2025

Australia's aesthetic market is entering a high-growth phase, with nearly 7 million adults considering cosmetic surgery and industry value projected at US$1.5 billion in 2024. Strong demand for injectables and advanced devices, supported by new national standards, offers aesthetic medical device manufacturers strong potential to introduce innovative solutions and capture growth in this dynamic market.

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2025-08-25

QT ACTIVITY: WHY AUSTRALIA IS THE IDEAL PARTNER FOR YOUR NEXT CLINICAL TRIAL WEBINAR RECAP - JULY/AUGUST 2025

On July 21, 2025, Qualtech hosted a webinar featuring Mobius Medical's Co-Founder and Clinical Director, Stefan Czyniewski, on "Accelerating Innovation: Why Australia Is the Ideal Partner for Your Next Clinical Trial". The session emphasized Australia’s speed and cost-efficiency under the Clinical Trial Notification (CTN) scheme, world-class infrastructure, and broad international acceptance of trial data. Key comparisons with the United States highlighted faster start-up timelines, simpler regulatory pathways, and substantial financial incentives such as the R&D Tax Rebate. With its favorable environment for early-phase medical device and diagnostic studies, Australia stands out as a strategic launchpad for global clinical development.

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2025-08-25

CHINA: Announcement of the National Medical Products Administration on Measures to Optimize Whole-Lifecycle Regulation to Support the Innovative Development of High-End Medical Devices (No. 63 of 2025) – JULY/AUGUST 2025

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

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理工科技 您的最佳選擇

Qualtech | 理工科技
醫療器材註冊

我們擁有二十年法規註冊經驗,並且在亞洲十個地區提供產品註冊服務,另在美國、歐洲、日本設立辦公室,提供客戶直接的服務,支持醫療器材製造商佈局亞洲市場。

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Qualtech | 理工科技
臨床試驗

我們是第一家執行且通過台灣衛生福利部GCP醫材臨床查核,也在中國通過多次GCP醫材查核。我們提供臨床試驗、臨床評價報告與上市後臨床追蹤等全方位服務。

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Qualtech | 理工科技
當地代理人

我們可擔任製造廠在當地的產品許可證管理者。協助您處理相關法規與上市後追蹤等活動,並提供即時的法規動態。您能更有效的管理產品許可證,並因應當地法規調整產品策略。

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理工科技 解決方案

多地註冊

多地註冊

我們提供多國註冊解決方案。 您只需要聯繫一個窗口並準備一套申報資料就能在短時間內讓您的產品在多國上市。

註冊臨床試驗整合方案

註冊臨床試驗整合方案

我們熟悉亞洲各地的臨床試驗要求,並根據註冊經驗設計臨床試驗,以滿足當地衛生部門的要求。我們在高風險產品擁有豐富取證經驗。

市場前規劃

市場前規劃

我們可以為您提供當地法規標準研究、市場調研、產品標準評估、經銷商媒合、進出口辦理和當地競品分析服務。