PIDC can assist you to request registration documents, organize registration documents, submit the registration application, supplement the registration documents to get the registration approval with Taiwan FDA.
Help to hold the QSD and product licenses in Taiwan.
Medical devices imported into Taiwan must comply with the quality management system that harmonized with ISO 13485, and submit the Quality System Documentation to Taiwan FDA.

According to the country of origin, the Application Pathway can be classified as:
■ US-Abbreviated
■ TCP-Abbreviated (Applicable to E.U.)
■ Japanese-Abbreviated
■ Standard QSD
■ Audit by TFDA in abroad

Although abbreviated pathway seems more convenient, the requirements of the documentation is still varied . Also, the communication with the original manufacturer takes time. PIDC can assist you in preparing the relevant documentation to obtain QSD approval with the highest efficiency.