Founded in 2000, Qualtech Consulting Corporation has been providing medical device manufacturers and distributors with high-quality services in Regulatory Consulting, Product Registration, Clinical Trials (CRO), Local Authorised Representatives, and Post-Market Activities.

Recognized widely for our professional knowledge and management excellence, we prepare a strategic market entry proposal customized to your product and individual needs. Having successfully registered over 5000 products and offering to also assist with Clinical Trials, CER Writing, and Distributor Search Services, Qualtech aims to provide our customers with a one-stop solution worldwide.

We specialize in Australia (TGA), China (NMPA), Hong Kong (MDD), Indonesia (MOH), Japan (PMDA), Malaysia (MDA), New Zealand (MEDSAFE), Philippines (PH-FDA), Singapore (HSA), South Korea (MFDS), Taiwan (TFDA), Thailand (Thai-FDA), US (FDA) and Vietnam (MOH). Contact us now!

GlobalRA@qualtechs.com
Taiwan: +886 2 2740 1778

Qualtech Medical Device Consulting

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Qualtech Medical Device Consulting

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