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

2023-01-20

Join our webinar with MDR Expert, limited seats available. Get it quick!

Enter EU market with confidence: Keep updated on MDR Regulation changes! Join Qualtech MDR webinar on 07 Feb 2023 (Tue) at 16:30 – 17:30 p.m. (GMT+8).

A perfect opportunity to prepare for the changes and minimize the impact on you.

2023-01-19

QT ANALYSIS: OVERVIEW OF NEW AND IMPACTING GLOBAL REGULATORY UPDATES – January/February 2023

The development of medical devices is significantly influenced by the rapid pace of technology. While these cutting-edge devices may improve healthcare services, they also pose major risks to public health and safety. Due to this, regulatory agencies throughout the world have been continuously developing and updating their regulations to strengthen their management of product registration and mandate that applicants submit more detailed documentation. This article will cover the recently issued, upcoming, and influential worldwide medical device regulation updates for the year 2023 in various countries.

2023-01-19

QT Activity: Qualtech's Internal Southeast Asian Regulatory Training and End of the Year Party 2022 – January/February 2023

Qualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.

2023-01-19

AUSTRALIA: Effects on Australia Registrations by the EU MDR Transition – January/February 2023

Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.

Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.

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

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Obtain Market Access via CER

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

Qualtech News

Join our webinar with MDR Expert, limited seats available. Get it quick!

QT ANALYSIS: OVERVIEW OF NEW AND IMPACTING GLOBAL REGULATORY UPDATES – January/February 2023

QT Activity: Qualtech's Internal Southeast Asian Regulatory Training and End of the Year Party 2022 – January/February 2023

AUSTRALIA: Effects on Australia Registrations by the EU MDR Transition – January/February 2023

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy