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

2021-04-20

QT ACTIVITY: 2021年新醫療器材管理法實施重點研討會

衛生福利部食品藥物管理署公告「醫療器材管理法」於110年5月1日正式實施。因應近期多項新法令之要求，理工科技顧問股份有限公司舉辦「2021年新醫療器材管理法實施重點」，協助廠商了解醫療器材新法令之要求及相關規定，並討論因應措施。報名日期自即日起至5月21日，額滿為止，敬請廠商踴躍報名！

2021-05-18

QT Webinar: European MDR - EU Access & PMCF

Qualtechs will be holding a Webinar focusing on EU MDR on May 25, 2021.

We welcome all interested guests to join for free.

2021-04-26

QT ANALYSIS: Dental implants market and registration requirements in Asia

Asia Pacific forms one of the most promising dental device markets in the world. In this edition of QT Analysis, we look into the market size waiting for you to take advantage of and the requirements to register your dental devices in this region.

2021-04-26

TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.

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