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

2026-08-25

QUALTECH WEBINAR: JAPAN & SOUTH KOREA – KEY REGULATORY DEVELOPMENTS FOR MEDICAL DEVICES – September 2026

Planning to enter or expand your medical device business in Japan or South Korea? Join Qualtech's free webinar on September 17, 2026, for a focused discussion on key regulatory developments shaping medical device market access in these two important Asian markets.
The session will cover practical considerations for leveraging existing biocompatibility reports for PMDA requirements and navigating South Korea’s evolving framework for digital healthcare products and digital medical devices.

2026-08-25

THAILAND: Thai FDA – Update Change Notification Details on Levels, Processing Timeframes, Assessment Conditions, and Applicable Fees – July/August 2026

Thailand has updated its operational framework for Class 2-4 medical device change notification. Revised processing timelines and fee structures have been established for both standard and expert review pathways. Medical device manufacturers and importers marketing products in Thailand must review the updated criteria, evaluation periods, and associated fees prior to submitting change requests to ensure full regulatory compliance.

2026-08-25

SINGAPORE: HSA EXTENDS PHASE 3 UDI COMPLIANCE DATE TO 31 DECEMBER 2026 – July/August 2026

Singapore's Health Sciences Authority (HSA) has extended the compliance date for Phase 3 implementation of Unique Device Identification (UDI) requirements from 1 November 2026 to 31 December 2026. Class C General medical devices and in vitro diagnostic (IVD) medical devices must therefore carry UDI labelling prior to import and supply in Singapore from 1 January 2027.

2026-08-25

MALAYSIA: Introduction of the Automated Re-Registration Route in MeDC@St 2.0+ for Streamlined Market Access and Continuous Supply of Medical Devices – July/August 2026

The Medical Device Authority (MDA) of Malaysia has announced the new Automated Re-Registration Route within the MeDC@St 2.0+ platform, effective from 13 July 2026. This initiative aims to support continuous product availability, reducing administrative workload, and improving regulatory efficiency while maintaining compliance with existing MDA requirements.

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 CERObtain Market Access via CER

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

Qualtech News

QUALTECH WEBINAR: JAPAN & SOUTH KOREA – KEY REGULATORY DEVELOPMENTS FOR MEDICAL DEVICES – September 2026

THAILAND: Thai FDA – Update Change Notification Details on Levels, Processing Timeframes, Assessment Conditions, and Applicable Fees – July/August 2026

SINGAPORE: HSA EXTENDS PHASE 3 UDI COMPLIANCE DATE TO 31 DECEMBER 2026 – July/August 2026

MALAYSIA: Introduction of the Automated Re-Registration Route in MeDC@St 2.0+ for Streamlined Market Access and Continuous Supply of Medical Devices – July/August 2026

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy