For global medical device markets, there are local regulatory requirements for various kinds of devices. Manufacturers must apply for approval from local authorities before sales and marketing in any country.
Qualtech, with more than 20 years of experience, is a medical device registration consulting firm that specializes in helping companies navigate the complex regulations in global markets. Our team of experts, across 13 nations, has a deep understanding of the regulatory environment worldwide and can overcome any barriers to entry with you.
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.
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.