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Quality System Documentation (QSD)
Under the Medical Devices Act, foreign medical device manufacturers need to get a quality system documentation review by TFDA and a manufacturing license (QSD certificate) to be registered with TFDA.
Foreign manufacturers must submit QSD before registering their devices, except for certain non-sterile, non-measuring Class I devices.
ISO 13485 certification is required as Taiwan's regulations align with it. Simplified QSD review processes are available for eligible manufacturers in the US, EU, Japan, Puerto Rico, Guam, Switzerland, and Liechtenstein.
Certification Timeline
The TFDA review process takes approximately 6 months and the estimated timeline for each step is provided below:
Initial Submission
Initial Phase of TFDA Review
The process takes around 1 to 2 months
1st TFDA Review Feedback
A response is required within 3 months
2nd TFDA Review
The process takes around 1 to 2 months
2nd TFDA Review Feedback
A response is required within 2 months
Appeal Submission
The process takes around 1 to 2 months
Final TFDA Review
The process takes around 2 months
QSD Certificate Issuance
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