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.

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Qualtech News

2026-04-01

Australia: Musculoskeletal Burden and Opportunities for Orthopedic Device Growth – February/March 2026

Musculoskeletal (MSK) conditions are a major health burden in Australia, ranking among the top 5 contributors to overall disease burden in 2024 and affecting nearly 7.3M people. Rising prevalence, aging demographics, and significant healthcare spending are driving growing demand for orthopedic technologies. As advanced solutions such as surgical robotics, smart implants, and regenerative therapies gain adoption, Australia's orthopedic sector continues to expand with increasing demand for innovative medical technologies.

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2026-03-31

NEW ZEALAND: Accessible Medical Device Entry & Growing Healthcare Demand | Qualtech 15th Office Expansion – February/March 2026

Qualtech's expansion into New Zealand, marked by the opening of our 15th office, highlights a market that combines accessible regulatory pathways with growing healthcare demand. With no pre-market approval required and a notification-based system, New Zealand offers an efficient entry route for medical devices. At the same time, increasing healthcare investment, aging population, and infrastructure development are driving demand for advanced medical technologies, positioning the market as a strategic opportunity within APAC.

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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.

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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.

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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.

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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

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