Product Registration, Clinical Trials, Local Representative, and Regulatory Services

Qualtech Consulting Corporation, founded in 2000 by Dr. Yin-Pen Chang, is a regulatory consulting service and clinical trial (CRO) company for medical devices. Operating with a cross-disciplinary team of professionals, integrity, diversity, continuous learning, and teamwork, Qualtech provides clients with effective one-stop solutions.
We have helped over 1,000 clients to gain market access in their desired locations and passed more than 5,000 medical device licenses with precision.

More Contact Us

Qualtech News

Qualtech Will Attend the 46th Beijing International Medical Devices Exhibition​ - September 2025
2025-09-12

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

Qualtech will participate in the 46th Beijing International Medical Devices Exhibition on September 17–19, 2025. As one of China's premier MedTech events, the exhibition offers a key platform for engaging with healthcare stakeholders and exploring regional opportunities. Our team will be on-site to provide guidance on regulatory strategy and market access across APAC region.

Book a 1-on-1 session to meet us at the event!​

more
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.

more
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.

more
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.

more

Qualtech Your best choice

Qualtech | 理工科技
Medical Device Registration

Having 20 years of regulatory registration experience, we offer product registration services in 10 Asian countries. Moreover, we set up the sales center in Japan, United State and Europe to provide direct customer service.

More
Qualtech | 理工科技
Clinical Trials

We provide a full range of services including clinical trials, clinical evaluation reports and post-marketing clinical follow-up. We are the first company to implement and pass the GCP by Taiwan FDA. We have also passed many GCP in China.

More
Qualtech | 理工科技
Authorized Representative

We can act as a local product license manager at the manufacturing facility. Help you with such activities as regulations and post-marketing tracking, and provide immediate regulatory updates.

More

Qualtech Solution

Multi-country Submission

Multi-country Submission

Qualtech provides you with multi-country registration solutions. What you need to do is only to contact a single window and prepare a set of documents.

One-Stop Registration

One-Stop Registration

Qualtech conducts clinical trials based on registered experience, which meets the needs of local health authorities; We are familiar with clinical trial requirements in the Asian market.

Market Access Strategy

Market Access Strategy

Qualtech can provide you with multi-regional regulatory research, market research, product standard assessment and competitive product search services

More

We collect your browsing history through cookies to understand how you use our website to analyze and improve your experience. By continuing to use our website, you accept our use of cookies.