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.

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Qualtech News

Australia: Artificial Intelligence (AI) is Transforming Australian Healthcare – October/November 2025
2025-11-26

Australia: Artificial Intelligence (AI) is Transforming Australian Healthcare – October/November 2025

Artificial Intelligence (AI) is rapidly transforming healthcare in Australia, offering innovative solutions to meet the growing demands of an aging population and chronic disease management. With the AI healthcare market projected to reach AUD 1.78 billion by 2030, AI's potential to enhance early diagnosis and optimize treatments is substantial. Despite challenges like data fragmentation and regulatory complexities, AI is set to revolutionize healthcare delivery across the country.

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2025-11-26

QT Activity: Southeast Asia Medical Device Compliance Update 2025 Webinar Recap Part 1: Indonesia, Thailand & Vietnam – October/November 2025

This article summarizes key insights from Qualtech's 2025 ASEAN regulatory webinar, highlighting major updates in Indonesia, Thailand and Vietnam. The recap covers changes in retail rules, procurement, halal enforcement, reliance pathways and registration procedures, reflecting how these markets are streamlining medical device approvals and improving regional market access.

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2025-11-26

Singapore: Health Products Regulatory Conference 2025 in conjunction with SMF MedTech Day – October/November 2025

On 2 October 2025, the Singapore Health Sciences Authority (HSA) conducted the Health Products Regulatory Conference 2025, which was held jointly with the Singapore Manufacturing Federation (SMF) MedTech Day. The event elevated the theme: "Advancing Singapore's Medtech Ecosystem: be connected, collaborative, and future-ready".
During the conference, the HSA's Medical Device Cluster (MDC) shared insights on the evolving regulatory landscape, examining both present developments and anticipated future trends in the field, especially related to digital health products.

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2025-11-21

Malaysia: Amendment Regulations 2025 [P.U. (A) 330] – Class A Change Payment Fee – October/November 2025

The Malaysian Medical Device Authority (MDA) has issued the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], which were gazetted on 11 September 2025. This amendment revises the fee structure for registrations of Class A medical device effective on or after 1 January 2026. Stakeholders are advised to review the changes and plan their submissions accordingly to ensure timely compliance.

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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.

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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.

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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.

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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

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