The major medical device markets have all have regulatory requirements for listing medical devices. Applicants who want to sell medical products locally need to obtain relevant certificates from local healthy ministry.
Qualtech has more than 20 years of registration experience in Asia and has set up local offices in 11 countries. We can assist your products to be listed smoothly in local markets on demand.
Qualtech provides a one-stop solution for testing and registration, using our regulatory experience to formulate a suitable test plan for your product.
We provide relevant pre-clinical tests, including biocompatibility, immune tests, virus tests, sterility tests, animal tests, electrical safety, software validation and other relevant international standards.
We have a professional and diverse regulatory team that can produce local regulatory research reports according to your needs, helping your company better understand the relevant regulations of the local government on medical devices in order to facilitate market advancement.