Founded by a team with high regards for integrity, we envision becoming a trusted institution of Health Authorities, clients and regulatory partners worldwide as we perform seamless regulatory procedures and business solutions.
We are catered to provide high-quality regulatory consultancy services and assistance to clients in launching medical device products throughout East Asia and ASEAN countries.
MEDICAL DEVICE REGISTRATION
With over 15 years of experience in medical device registration, our in-house experts are able to provide you with excellent regulatory services by compiling well-organized submission documents and offering feasible solutions to get your products across 9 countries in Asia.
Our local associates are experienced in engaging with legal authorities to ensure that your medical devices successfully pass rigorous import requirements. We also connect you to FDA-accredited distributors that are able to fulfill your needs and expectations.
LOCAL AUTHORIZED REPRESENTATIVE
Qualtech can hold product registration licenses on behalf of foreign manufacturers. This service is expedient for companies planning to market their devices in countries which, by law, require a local establishment to be the license holder.
Having continuously reported strong performances in GCP Inspections in China and Taiwan since our CRO initiation in the year 2008, we take pride on having successfully coordinated various clinical trial projects for high-risk and implantable devices.
A professionally written clinical evaluation report (CER) can help you obtain product approvals smoothly. We have many years of experience in preparing CER that meets all requirements from various regions.
Our professional research assistant team is fully equipped to prepare customized regulatory research reports based on your preference.
Collagen Intradermal Fillers
Collogen Matrix Implant
Proton Therapy System
Diagnosis Imaging Software