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Qualtech Consulting Corporation

Increase Your Global Outreach with Asia-Pacific Regulatory Excellence.

2000 - Present (25+ years)

Headquarters: Taipei, Taiwan

About Qualtech Consulting Corporation

Founded in 2000, Qualtech Consulting Corporation is a medical device regulatory consulting service and clinical trial (CRO) company. We provide manufacturers with high-quality services in Product Registration, Local Authorized Representation, Post-Market Activity, and help expand business worldwide with over 20 years of experience and an international network.

Why Choose Qualtech Consulting Corporation?

Over 25 years of experience in the medical device market

Local representation in 13 markets worldwide (Operates Locally through subsidiaries)

Expert Teams with Extensive Experience (one-stop solution)

An Excellent Management System to Ensure Time-efficient Project Handling

Proven Track Record (5000+ devices registered, 2000+ clients)

Specializations

7+ Services

Global Presence

13 Offices

Languages

9 Languages

Markets

13 Regions

Recent Updates

Southeast Asia Medical Device Compliance Update 2025 Webinar Recap Part 1: Indonesia, Thailand & Vietnam

October/November 2025

Regulatory Update

產品註冊

China NMPA

Japan PMDA

Singapore HSA

Indonesia MoH

Philippines FDA

Vietnam MoH

Malaysia MDA

Thailand FDA

Taiwan FDA

HongKong MDD/MDACS

Australia TGA

Korea MFDS

Clinical & Testing

Clinical Trials

Clinical Evaluation Reports (CER)

Pre-clinical tests

Local Services

Local Authorized Representation

Post-Market Surveillance

Import/Export Handling

Strategy

Multi-country Submission

Regulatory Research

Market Access Strategy

Global Office Network

With 13 offices worldwide, Qualtech Consulting Corporation provides local expertise and support across Asia Pacific, Europe, and North America.

Taiwan

China

Japan

Singapore

Hong Kong

Malaysia

Philippines

Vietnam

Australia

Germany

Korea

Thailand

USA

1Fl., No.13, Lane 103, Sec. 1, Sinsheng S. Rd. Taipei City, Da'an Dist., Taiwan 10652

Ready to Get Started?

Contact Qualtech Consulting Corporation today to discuss your regulatory needs across Asia Pacific markets.