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Regulatory Submission Consultation

(1) TFDA Premarket Submission Consultation

  • A FREE appeal can be made to TFDA if a submission is rejected.
  • No additional information will be requested in a re-submission.
  • For re-submission, the average time consumed by TFDA is 4 to 6 months.

(2) FDA Pre-submission (Q-Submission) Consultation

Average pre-submission working time for FDA: 75 to 90 days

  SEQPRO’s Working Time Client’s Working Time Total Working Time
1. Preparation 7 days TBD 7 days + TBD
2. Review 7 days TBD 7 days + TBD
3. Finalization 14 days TBD 14 days + TBD
4. Application 3 days N/A

(3) FDA 510(k) Submission Consultation

  SEQPRO’s Working Time Client’s Working Time Total Working Time
1. Preparation 2 weeks TBD 2 weeks + TBD
2. Draft Review 2 weeks TBD 2 weeks + TBD
3. Documentation 4 weeks TBD 4 weeks + TBD
4. Application 1 week N/A

Address

6F.-3, No.371, Sec. 1, Guangfu Rd., East Dist., Hsinchu City 30074, Taiwan (R.O.C.)

Contact

Tel：+886-3-666-0139
Fax：+886-3-666-0149
Email: services@seqpro.com.tw