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

2022-04-27

Japan Registration: A Guide on Data Preparation

On March 25th, 2022, Qualtech held an online seminar to introduce Japanese health authorities' requirements on technical data, which can be submitted during PMDA/RCB's approval process.

2022-04-27

USA: FDA's New Classification of the Interoperable Automated Glycemic Controller – April, 2022

The US FDA is classifying the interoperable automated glycemic controller into class II. Also, the codified language for the interoperable automated glycemic controller is taken as a part of the device to the special control.

2022-04-27

TAIWAN: Updates in the Product Registration Guidance for Artificial Intelligent/Machine Learning-Based Software as a Medical Device – April, 2022

Concerning the rapid development of Artificial Intelligent/Machine Learning-Based SaMD, TFDA has updated the related guidance that was initially announced in 2020. The latest requirements are summarzied in this article.

2022-04-27

THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

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

QT Webinar: New CER Requirements in China

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

Qualtech News

Japan Registration: A Guide on Data Preparation

USA: FDA's New Classification of the Interoperable Automated Glycemic Controller – April, 2022

TAIWAN: Updates in the Product Registration Guidance for Artificial Intelligent/Machine Learning-Based Software as a Medical Device – April, 2022

THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy