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

2021-12-27

QT WEBINAR: New CER Requirements in China

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "New CER Requirements in China". Our event is scheduled to be held on January 21st (Friday), 2022.

2021-12-27

PHILIPPINES: PFDA Announced Abridged Route for Medical Device Notification and Registration Applications – November, 2021

PFDA announced that abridged route for processing of Registration and Notification Applications for Medical Devices will commence starting Nov 25. This aims to increase the efficiency of public access to safe, quality, and effective medical devices

2021-12-27

MALAYSIA: MDA Introduces Additional Approval Types To Be Issued by Conformity Assessment Bodies – December, 2021

MDA now recognizes MHRA, UK is now an additional recognized foreign regulatory agency by the MDA and its approval type for Great Britain and Northern Ireland can be used for medical devices to undergo a simplified registration route (by conformity assessment) in Malaysia.

2021-12-27

MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.

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

QT Webinar: New CER Requirements in China

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

Qualtech News

QT WEBINAR: New CER Requirements in China

PHILIPPINES: PFDA Announced Abridged Route for Medical Device Notification and Registration Applications – November, 2021

MALAYSIA: MDA Introduces Additional Approval Types To Be Issued by Conformity Assessment Bodies – December, 2021

MALAYSIA: Conditional Approval for Supply of Covid 19 Self Test Kits – December, 2021

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy