Solution

Market Access Solutions

Entering The Asian Market

Multi-country market listing can be a headache for any medical device company. In addition to the workload of connecting with  different companies, it is also exhausting to deal with the problems raised by local health authorities.

Qualtech provides you with multi-country registration solutions. For our clients, you only need to contact a single window and prepare just one set of documents, then, you will obtain marketing authorizations in multiple countries at the same time, and simultaneously expand the Asian market.

Markets you may be interested in

ChinaJapanVietnamThailandIndonesiaSingaporePhilippinesMalaysiaTaiwanHongKong

Shortened Registration Timeline for High-risk Device

The lengthy process of performing clinical trials will prevent you from keeping up with the rapidly changing market. Sometimes the clinical trial report does not meet the requirements for review and will directly leads to restarting costly clinical trials.

Qualtech conducts clinical trials based on our abundant experiences making sure that the results will meet the requirements of local health authorities. We are familiar with the requirements and procedures in the Asian market, allowing you to use just one clinical trial report for multiple registrations.

Services you may be interested in

Clinical trial services, Product registration services

Exclusive Asian Regulatory Research Reports

Information in most Asian countries is provided in the local language, which prevents many medical device companies interested in entering the market from obtaining real-time information and then formulating a suitable market plan.

Qualtech can provide you with multi-regional regulatory research, market research, product standard assessment and competitive product search services, allowing your company to quickly grasp the environment of the target market, and formulate accurate and efficient market access strategies.