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

2023-02-23

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

2023-02-23

China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

2023-02-23

EU: MDCG 2023-2 - List of Standard Fees for Notified Bodies – February/March 2023

According to the MDR and the IVDR, notified bodies shall make their standard fees public. In this guidance, the MDCG clarifies the requirements of the list of standard fees and provides the corresponding templates.

2023-02-23

EU: Update - Coverage of Designation Codes by MDR/IVDR Notified Bodies – February/March 2023

The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.

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

E-mail

Obtain Market Access via CER

Product Registration, Clinical Trials, Local Representative, and Regulatory Services

Qualtech News

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

EU: MDCG 2023-2 - List of Standard Fees for Notified Bodies – February/March 2023

EU: Update - Coverage of Designation Codes by MDR/IVDR Notified Bodies – February/March 2023

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy