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

2022-07-26

QT ANALYSIS: Shifts in the Chinese Medical Device Market – July 2022

China’s medical device market has continued to increase over the last years due to the rapid pace of technology and innovation, increase on its aging population, and demands for better healthcare services in the wake of the COVID-19 pandemic. Given the said market growth rate, plenty of opportunities are available for foreign companies to grab and make profits from the situation. In this article, the changes in the Chinese medical device market and factors to be considered by foreign manufacturer in entering the market will be explored.

2022-07-26

BNO Promotion: Medical Contract Manufacturing Services for Silicone, Plastic, and Rubber Components by Baron Rubber

As part of the partnership between Qualtech and Australia-based Baron Rubber, we would like to provide our clients and readers with contract manufacturing services for all types of medical silicone, plastic, and rubber components. Therefore, Baron’s expertise and service scope has been summarized in the following article.

2022-07-26

BNO Promotion: Quickly Establishing your UDI Management System via WhaleTeq's UDIBar – A UDI Generator and Label Management System

Given the international trend of more and more authorities requiring the implementation of Unique Device Identification, such as by US FDA, via the new European MDR, as well as by Taiwan FDA, Qualtech would like to share with our readers a useful tool to help you establish your UDI management system. That is, via the UDI Generator and Label Management System called "UDiBar" by WhaleTeq.

2022-07-26

USA: US Medical Device Classification Update: Intravascular Bleed Monitor & The Non-Implanted Electrical Stimulation Devices – July, 2022

According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.

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: Shifts in the Chinese Medical Device Market – July 2022

BNO Promotion: Medical Contract Manufacturing Services for Silicone, Plastic, and Rubber Components by Baron Rubber

BNO Promotion: Quickly Establishing your UDI Management System via WhaleTeq's UDIBar – A UDI Generator and Label Management System

USA: US Medical Device Classification Update: Intravascular Bleed Monitor & The Non-Implanted Electrical Stimulation Devices – July, 2022

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy