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

2026-11-09

Qualtech Webinar: Clinical Evidence Requirements and the Clinical Investigation Landscape to Access the European Market – November 2026

Qualtech invites you to join our free webinar on Thursday, November 26, 2026, with the topic "Clinical Evidence Requirements and the Clinical Investigation Landscape to Access the European Market". In collaboration with Spain-based CRO Iberania, our invited regulatory expert and guest speaker will share practical insights into the clinical evidence requirements under the EU MDR and how to best conduct clinical investigations in Europe, so that successful market access and regulatory compliance can be ensured.

2026-10-27

Australia's Type 1 Diabetes Market: Device Demand, Reimbursement and TGA Regulatory Signals – September/October 2026

Australia's type 1 diabetes market presents opportunities for medical device companies, particularly in continuous glucose monitoring (CGM), as government subsidies support access to diabetes technologies. This article examines market growth, reimbursement arrangements and key Therapeutic Goods Administration (TGA) requirements, including Australian Register of Therapeutic Goods (ARTG) inclusion and unique device identification (UDI) compliance. It also explores opportunities across diabetes device categories and outlines practical considerations for companies planning to enter the Australian market.

2026-10-27

QT Activity: Webinar Recap | JAPAN & SOUTH KOREA: KEY REGULATORY DEVELOPMENTS FOR MEDICAL DEVICES – September/October 2026

Qualtech's webinar on September 17, 2026 reviewed key regulatory developments for medical devices in Japan and South Korea. The Japan session covered how existing biocompatibility reports can support PMDA submissions, including JIS T 0993-1:2020 requirements, material documentation, GLP compliance and the acceptance of overseas test data. The South Korea session outlined the Digital Medical Products Act framework, covering device status determination, classification, regulatory pathways, K-GMP and post-market obligations.

2026-10-27

QT Analysis: Taiwan TFDA Upgrades IVD Regulatory Requirements for CRP and AST Systems – How Should Companies Adjust Their Market Strategy? – September/October 2026

Taiwan's Food and Drug Administration (TFDA) released new guidance in August and September 2026 for C-Reactive Protein (CRP) assays and Antimicrobial Susceptibility Testing (AST) systems, two Class II in vitro diagnostic (IVD) device categories. The updates require CRM470 calibration traceability and additional clinical data for hsCRP cardiovascular risk claims, as well as multi-center accuracy studies for AST systems. This analysis reviews the key changes, their impact on registration timelines and market competition, and the value of an early technical documentation gap analysis.

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

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Obtain Market Access via CER

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

Qualtech News

Qualtech Webinar: Clinical Evidence Requirements and the Clinical Investigation Landscape to Access the European Market – November 2026

Australia's Type 1 Diabetes Market: Device Demand, Reimbursement and TGA Regulatory Signals – September/October 2026

QT Activity: Webinar Recap | JAPAN & SOUTH KOREA: KEY REGULATORY DEVELOPMENTS FOR MEDICAL DEVICES – September/October 2026

QT Analysis: Taiwan TFDA Upgrades IVD Regulatory Requirements for CRP and AST Systems – How Should Companies Adjust Their Market Strategy? – September/October 2026

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy