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

2022-06-30

QT ANALYSIS: Innovative Medical Device Trends To Be Observed in the Upcoming Medical Fairs in the Asia-Pacific Region – June, 2022

Given the return and the increased popularity of in-person medical exhibitions, Qualtech has taken the opportunity to provide you with a sneak peek of the innovative medical device trends to be observed in ASEAN’s upcoming big medical exhibitions and fairs. This includes, among other fields, wearable technology, augmented reality for surgeon training and pre-operation planning, as well as virtual reality surgery with robotic and artificial intelligence assistance.

2022-06-29

USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.

2022-06-29

THAILAND: Thai FDA Introduced an Application Route to Verify Risk Classification and Medical Device Grouping – June, 2022

The termination of Thai FDA's "Pre-Submission" resulted in the establishment of a new route to determine product risk classification and medical device grouping via the E-submission system.

2022-06-29

MALAYSIA: MDA updates the Second Edition Guidance Document MDA/GD/0009: Rules Of Classification For General Medical Devices – June, 2022

The Malaysia Medical Device Authority (MDA) released the 2nd Edition of Guidance on The Rules of Classification for General Medical Devices MDA/GD/0009 on May 9, 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

QT ANALYSIS: Innovative Medical Device Trends To Be Observed in the Upcoming Medical Fairs in the Asia-Pacific Region – June, 2022

USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

THAILAND: Thai FDA Introduced an Application Route to Verify Risk Classification and Medical Device Grouping – June, 2022

MALAYSIA: MDA updates the Second Edition Guidance Document MDA/GD/0009: Rules Of Classification For General Medical Devices – June, 2022

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy