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

2023-11-20

QT ACTIVITY: KOREA MARKET EXPANSION AND CHINA NMPA UPDATES WEBINAR SUMMARY - NOVEMBER/DECEMBER 2023

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.

2023-11-20

EU: COMMISSION DELEGATED REGULATION (EU) 2023/2197 AS REGARDS THE ASSIGNMENT OF UNIQUE DEVICE IDENTIFIERS FOR CONTACT LENSES - NOVEMBER/DECEMBER 2023

A regulation governing the assignment of Unique Device Identifiers (UDI) for contact lenses has been published.

2023-11-20

EU: MDCG 2023-4 - MEDICAL DEVICE SOFTWARE (MDSW) – HARDWARE COMBINATIONS GUIDANCE ON MDSW INTENDED TO WORK IN COMBINATION WITH HARDWARE OR HARDWARE COMPONENTS – NOVEMBER/DECEMBER 2023

This guidance provides clarifications on which specific regulatory considerations apply when the hardware or hardware component are classified as a medical device or an accessory to a medical device.

2023-11-20

EU: Q&A ON TRANSITIONAL PROVISIONS FOR PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE COVERED BY ANNEX XVI OF THE MDR - NOVEMBER/DECEMBER 2023

This Q&A document answers questions on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR.

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: KOREA MARKET EXPANSION AND CHINA NMPA UPDATES WEBINAR SUMMARY - NOVEMBER/DECEMBER 2023

EU: COMMISSION DELEGATED REGULATION (EU) 2023/2197 AS REGARDS THE ASSIGNMENT OF UNIQUE DEVICE IDENTIFIERS FOR CONTACT LENSES - NOVEMBER/DECEMBER 2023

EU: MDCG 2023-4 - MEDICAL DEVICE SOFTWARE (MDSW) – HARDWARE COMBINATIONS GUIDANCE ON MDSW INTENDED TO WORK IN COMBINATION WITH HARDWARE OR HARDWARE COMPONENTS – NOVEMBER/DECEMBER 2023

EU: Q&A ON TRANSITIONAL PROVISIONS FOR PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE COVERED BY ANNEX XVI OF THE MDR - NOVEMBER/DECEMBER 2023

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy