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

2021-10-04

QT ACTIVITY: Qualtech's Japan Webinar Provided a Detailed Overview on the Japanese Regulatory System – SEPTEMBER, 2021

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.

2021-09-30

NMPA's Implementation of Decree No. 47 and Decree No. 739 Bring Major Changes for Medical Device Registration in China:

On July 22, 2021, the China State Administration for Market Regulation has released a new version of the "Administrative Measures for the Registration and Filing of Medical Devices", which will be executed and come into effect on October 1, 2021.

2021-09-28

QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

2021-09-29

MALAYSIA: Import and Distribution of Covid-19 Self-Test Kit through Conditional Approval– September, 2021

MDA wants to advise any organization interested to import and distribute the Covid-19 Self-Test Kit for the Malaysian market to apply through the Conditional Approval Application with MDA.

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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Obtain Market Access via CER

QT Webinar: Japan Medical Device Registration