Market Access Solutions

Entering The Asia-Pacific Market

Navigating the complexities of multi-country medical device listing can be a daunting task for manufacturers. It demands not only comprehensive documentation but also technical skills and adept knowledge to address queries from official reviewers.

At Qualtech - your one-stop solution for tailor-made multi-country registration. With us, you have a single point of contact guiding you through the intricate regulatory landscape, paving your way to the lucrative Asia-Pacific markets. Experience Qualtech’s advantage and make your mark in the global arena!

Markets you may be interested in


One-stop for Entering Multiple Markets

Clinical trials are the lifeblood of medical device innovation. However, they can often be bogged down by various factors, leading to delays and escalating costs.

That’s where Qualtech comes into play. We delve into the specifics of your unique product, enabling us to design a tailor-made clinical study protocol fulfilling targeted countries requirements and implement clinical trials efficiently among high-risk and implantable devices . What’s more, our experienced medical writing team is adept at conducting clinical research evaluations and preparing comprehensive Clinical Evaluation Reports (CER). With Qualtech, you’re not just conducting clinical trials, you’re paving the way for multiple markets registrations simultaneously. Besides, Qualtech’s authorized representative service support post-market surveillance of various products.

Services you may be interested in

Clinical trial services, Product registration services

Develop a Distinctive Market Access Strategy

The language barrier can often pose a formidable challenge for medical device manufacturers. In most Asian countries, crucial regulatory news and updates are delivered exclusively in local languages. This could result in delays in receiving vital market news and hinder timely revisions of business plans in specific regions.

That’s where Qualtech steps in. With our local offices and a team of experts spread across the Asia-Pacific region, we are equipped to craft unique market access strategy for every medical device. We keep you updated with the latest regulatory news, provide local market research, product standard assessments, and competitor search services. With Qualtech, you are always one step ahead in the game!