Qualtech: Medical Device Consulting

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.

Qualtech News

2024-12-16

QT Promotion: Streamlining Medical Device Registration and Compliance in China with Qualtech – December/January 2025

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.

2024-12-16

Artificial Intelligence (AI) Paves the Way for Proactive Health Management in Korea – December/January 2025

South Korea is transforming healthcare with AI, enabling personalized nutrition, early disease detection, and proactive health management. AI systems, like one that diagnosed lung cancer with 94% accuracy, showcase its potential. The technology also accelerates drug development, opening new opportunities for AI-powered medical device companies.

2024-12-16

Australia: Australia Aligns with US FDA Standards: Faster Market Access for Class IIa and III Devices – December/January 2025

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

2024-12-16

EU: MDCG 2024-13 - Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – December/January 2025

This guidance clarifies the regulatory framework for the use of EtO in sterilizing medical devices and in vitro diagnostic medical devices.

Qualtech Your best choice

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.

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.

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.

Qualtech Solution

E-mail

Obtain Market Access via CER

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

Qualtech News

QT Promotion: Streamlining Medical Device Registration and Compliance in China with Qualtech – December/January 2025

Artificial Intelligence (AI) Paves the Way for Proactive Health Management in Korea – December/January 2025

Australia: Australia Aligns with US FDA Standards: Faster Market Access for Class IIa and III Devices – December/January 2025

EU: MDCG 2024-13 - Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – December/January 2025

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy