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

QT Activity: Medical Device Approval in Australia – What You Need to Know in 2025 Webinar Recap – April/May 2025
2025-04-24

QT Activity: Medical Device Approval in Australia – What You Need to Know in 2025 Webinar Recap – April/May 2025

On March 26, 2025, Qualtech hosted a regulatory webinar exploring the process of medical device approval in Australia. The session covered essential topics including device classification, conformity assessment options, ARTG registration steps, sponsor and manufacturer obligations, post-market surveillance, and upcoming UDI requirements. Practical tips and FAQs helped attendees better prepare for TGA submissions and long-term compliance in the Australian market.

more
2025-04-24

Australia: Breakthrough in Cardiac Transplants: The Future of Artificial Hearts – April/May 2025

The Total Artificial Heart (TAH) project, supported by a hefty AUD50 million investment from the Australian Government, is poised to redefine the future of cardiac care. As it progresses into the stage of human trials, the TAH could potentially serve as a viable long-term solution to heart transplants, thereby establishing Australia as a global leader in the fight against cardiovascular diseases.

more
2025-04-24

Australia: Understanding TGA's New Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal-Origin Substances – April/May 2025

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

more
2025-04-24

Australia: Unique Device Identification (UDI) Requirements: What Medical Device Manufacturers Must Know for Compliance in 2025–2030 – April/May 2025

Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.

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.