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

2021-11-24

What's New in Line for the ASEAN Medical Device Regulations in 2022 – November, 2021

2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, Thailand, Vietnam and Philippines.

2021-11-24

AUSTRALIA: 2022 Prospective Overview for Regulatory Affairs – November, 2021

2021 saw some new regulations being introduced by the TGA, especially on reclassified medical devices, software and increased effort on safe post market vigilance. Let’s take a look at what awaits the Australia medical device regulatory landscape in 2022.

2021-11-24

MALAYSIA: Covid19 Self-Test Market in Malaysia – November, 2021

In collaboration with the Ministry of Domestic Trade and Consumer Affairs (KPDNHEP), the controls for the expansion of self-test kit sales will be implemented. The Covid-19 self-test kit can only be purchased from licensed community pharmacies and authorized health facilities.

2021-11-24

PHILIPPINES: PFDA to Start Regulating Medical Device Retailers – November, 2021

In an effort to combat the proliferation of unregistered/unnotified medical device products in various establishments and platforms, PFDA released the guidelines on the licensing of retailers of medical devices in the Philippines.

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: Japan Medical Device Registration

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

Qualtech News

What's New in Line for the ASEAN Medical Device Regulations in 2022 – November, 2021

AUSTRALIA: 2022 Prospective Overview for Regulatory Affairs – November, 2021

MALAYSIA: Covid19 Self-Test Market in Malaysia – November, 2021

PHILIPPINES: PFDA to Start Regulating Medical Device Retailers – November, 2021

Qualtech Your best choice

Medical Device Registration

Clinical Trials

Authorized Representative

Qualtech Solution

Multi-country Submission

One-Stop Registration

Market Access Strategy