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

2026-05-22

MALAYSIA: Joint Announcement for Full Implementation of Medical Devic Regulatory Reliance Programmed Between MDA (Malaysia) and Thai FDA (Thailand) – April/May 2026

The Medical Device Authority (MDA) of Malaysia and the Thailand Food and Drug Administration (Thai FDA) have officially announced the successful completion of a three-month pilot phase, which took place from 1 February 2026 to 30 April 2026. Following this pilot phase, the full implementation of the MDA–Thai FDA Medical Device Regulatory Reliance Programme will now apply to the registration of Class B, Class C, and Class D medical devices.

2026-05-22

QT Activity: Webinar Recap | EU MDR 2026 Update: Practical Insights on Transition, Documentation & Compliance Strategy – April/May 2026

As EU MDR expectations continue to intensify in 2026, manufacturers are facing greater scrutiny across technical documentation, clinical evidence, and lifecycle compliance. Qualtech's webinar recap highlights practical insights on MDR transition planning, Annex XVI obligations, notified body expectations, and key compliance priorities shaping EU market access strategies.

2026-04-28

Malaysia: MDA Regulatory Updates – Publication of Second Edition Guidance on Definition of Medical Device – March/April 2026

The Medical Device Authority (MDA) has published the latest edition of the guidance document Definition of Medical Device which provides additional clarification on the definition and regulatory interpretation of medical devices, including accessories, components, and spare parts. The document is intended to assist industry stakeholders in the proper identification of device classifications and ensuring compliance with the Medical Device Act 2012 (Act 737).

2026-04-28

Malaysia: MDA Regulatory Updates – Publication of First Edition Application for Confirmation Status of Obsolete and Discontinued Medical Device – March/April 2026

The Medical Device Authority (MDA) has published the new guidance document, Application for Confirmation Status of Obsolete and Discontinued Medical Device (MDA/GD/0071). This publication was to assist establishments and healthcare professionals in understanding the applicable regulatory framework and in implementing appropriate control measures for obsolete and discontinued medical devices.

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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