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

2020-10-19

THAILAND: Food and Drug Administration Announcement Regarding the Document Preparation for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal – October, 2020

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

2020-10-19

European Union: CE Marking/Certification To Be Valid Until 30 June 2023 in Great Britain – October 2020

Since MDR/IVDR will not automatically apply in UK from 1 January 2021, MHRA has published a new guidance document related to how medical devices will be regulated in the Great Britain after that. According to the guidance, CE marking/certification will be valid until 30 June 2023 for the Great Britain market.

2020-10-15

FAQs for TFDA Good Distribution Practice (GDP)

2020-09-15

VIETNAM: Vietnam submission fees in medical sector are reduced 30% until the end of 2020 – September, 2020

In Vietnam, the fees for processing applications for license to sell and import medical devices will be reduced 30% from July 8th 2020 to December 31th 2020.

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.

Local agent

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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