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

2021-04-16

QT ANALYSIS: Taiwan Good Distribution Practice (GDP) Inspection Timeline

The latest GDP Inspection Timeline announced by Taiwan FDA is brought to you by Qualtech!

2021-03-29

Qualtech Activity: Qualtech’s Specialists Share Their Expertise at the Online Conference for the ASEAN Healthcare Markets – March, 2021

Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.

2021-03-22

MALAYSIA: Keeping Up with Post-Market Surveillance Requirements in Malaysia – MARCH, 2021

In Malaysia, Post-Market Surveillance and Vigilance (PMSV) is regulated under the Medical Device Act 2012 (Act 737) and Medical Device (Duties and Obligations of Establishment) Regulations 2019. In this edition of QT Analysis, tag along with us to keep updated on the latest PMSV requirements in Malaysia.

2021-03-22

VIETNAM: Instructions For Registration of Imported Medical Equipment Products In Vietnam.

Department of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.

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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