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

2026-07-27

QT Activity: Webinar Recap I Unlocking ANZ Market Access: Australia TGA Updates & New Zealand Entry Made Simple – June/July 2026

Qualtech's recent webinar provided practical insights into medical device market entry in Australia and New Zealand, covering Australia's ARTG inclusion process, post-market obligations, new UDI requirements, and New Zealand's WAND notification framework. The session also highlighted key regulatory updates and practical considerations for manufacturers planning expansion into the ANZ market.

2026-07-27

Singapore: HSA Warns Against Online Purchase of Contact Lenses and Removes Illegal Health Product Listings – May/June 2026

HSA has recently stepped up its efforts to combat illegal and unregistered health products through both consumer advisories and enforcement activities. In its latest announcements, HSA warned against the online purchase of contact lenses and reported the removal of 959 illegal health product listings, with unregistered contact lenses accounting for over 82% of the cases. The authority also reminded sellers that non-compliance may result in enforcement actions, including product seizures, investigations, prosecution, fines and imprisonment. These developments highlight Singapore's continued focus on protecting public health and strengthening oversight of regulated medical devices.

2026-07-27

Philippines: An Overview of the Proposed FDA Guidelines for Variations to Issued Product Authorizations for Medical and Health-Related Devices – June/July 2026

The Philippine FDA has issued a draft Circular proposing a comprehensive risk-based framework for post-approval variations of medical and health-related devices. Key proposed changes include the introduction of risk-based variation classifications, a dedicated variation pathway for medical device software (MDSW), single variation applications for eligible multiple product authorizations, updated submission procedures, and enhanced post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers. The draft also provides guidance on timelines, fees, and regulatory enforcement to support a more standardized variation process.

2026-07-27

MALAYSIA: Revision to the Requirements for Foreign Manufacturer Contact Details in the Requirement for Labelling of Medical Devices (MDA/GD/0026) – June/July 2026

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

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

QT Activity: Webinar Recap I Unlocking ANZ Market Access: Australia TGA Updates & New Zealand Entry Made Simple – June/July 2026

Singapore: HSA Warns Against Online Purchase of Contact Lenses and Removes Illegal Health Product Listings – May/June 2026

Philippines: An Overview of the Proposed FDA Guidelines for Variations to Issued Product Authorizations for Medical and Health-Related Devices – June/July 2026

MALAYSIA: Revision to the Requirements for Foreign Manufacturer Contact Details in the Requirement for Labelling of Medical Devices (MDA/GD/0026) – June/July 2026

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy