Multi-market listing registration can be a headache for every medical device company. In addition to connecting with the contact windows of different companies, it is also tiring to cope with the problems raised by local health authorities.
Qualtech provides you with multi-country registration solutions. What you need to do is to contact a single window and prepare a set of documents, then, you will obtain marketing authorizations in multiple countries at the same time, and simultaneously expand the Asian market.
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.
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!