We, Supharm, assist to request registration documents, organize registration documents, submit the registration application, supplement the registration documents to get the registration approval with Taiwan FDA.

  • Medical Devices and QSD regulatory affairs consulting and product registration (& change registration) approval
  • Identify the product category (class I/ II/ III)
  • Medical device registration and QSD registration (change-registration) with Taiwan FDA
  • As per your needs to market for product, Supharm will assist to get the QSD, medical device license approval. Supharm can assist to hold the QSD and medical device license in Taiwan.
  • Price Reimbursement registration for Medical Devices with NHIA Assisting to apply and obtain the price reimbursement as per your needs.
  • Post-market follow to TFDA for ADR report if occurred.
  • Help to hold the QSD and product licenses in Taiwan.