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.
- IVD and QSD regulatory affairs consulting and product registration (& change registration) approval
- Identify the product category (class I/ II/ III)
- IVD registration and QSD registration (change-registration) with Taiwan FDA
- As per your needs to market for product, Supharm will assist to get the QSD and IVD license approval. Supharm can assist to hold the QSD and IVD 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.