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

Asia Pacific: Aesthetic Devices Market Enters a Defining Growth Phase – September/October 2025
2025-10-27

Asia Pacific: Aesthetic Devices Market Enters a Defining Growth Phase – September/October 2025

The Asia Pacific aesthetic devices market will grow from USD 5.0 billion in 2024 to USD 11.5 billion by 2032, driven by minimally invasive treatments, innovation, and medical tourism. Emerging trends in preventive care, home-use devices, and male aesthetics create diverse opportunities across China, Japan, South Korea, Thailand, and Vietnam. Manufacturers that adapt to local demand and regulations will capture this expanding market.

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2025-10-27

QT ACTIVITY: QUALTECH AT CMEH 2025 BEIJING – EXPLORING NEW PATHWAYS FOR CHINESE MEDTECH GLOBALIZATION – SEPTEMBER 2025

Qualtech participated in the 46th China International Medical Equipment Exhibition (CMEH 2025) in Beijing, engaging with leading domestic manufacturers and industry experts to explore new pathways for Chinese MedTech globalization. The event served as a valuable platform for dialogue on international market expansion, regulatory challenges, and compliance strategies. As a trusted regulatory partner, Qualtech remains dedicated to helping Chinese innovators bring their high-quality medical devices to the global stage.

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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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