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Appoint a License Holder in Taiwan
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Product Classification: Class I (low risk), Class II (medium risk)
Class III (high risk) -
QSD letter
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Product Registration
Medical Device Registration in Taiwan
apply for QSD letter by providing QMS documents. The second step is to
apply for product registration by providing technical documents for review.
These two steps could be applied in parallel. For Class III device, it is necessary
to provide documents in STED (Summary of Technical Documentation) format
according to Guidance published by Global Harmonization Task Force,GHTF.
- Step 1: QSD letter
It is necessary to apply for QSD letter in order to prove that the
physical manufacturer is in compliance with Taiwan GMP
(ISO 13485).You may provide quality system documents
for review instead of onsite inspection. - Step 2: Product approval
Make sure that the product is allowed to be market on the original country
by providing the FSC (or CFG).Provide product dossier to prove that
the device performs as safe and effectiveness as the predicate device.
License Holder
We could be your license holder in Taiwan.
Flow Chart
Submission Package Preparation → Acceptance Review → 1st Review TFDA
(3months) → Additional Information Request (2 months)
→ 2nd Review TFDA (3 months)→ Defense (4 months)
→ Final Review TFDA (3 months)→ Finalized
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We are familiar with US FDA medical device regulation and quality system regulation (QSR)GMP compliance or MDSAP. US FDA medical device premarket notification 510 (k)US FDA medical device premarket approval PMA
CDRH Device Classification Panel 510 (k) Submission: Traditional, Abbreviate, Special PMA Registration and Listing |
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EU CE Marking |
EU Reguation MD Regulation
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Product Classification
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Medical Device Classification | |
Part I | |
Part II | |
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Health Canada |
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List of registrars recognized by Health Canada | |
Latin America | |
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Brazil ANVISA |
Agencia Nacional de Vigilancia Sanitaria | |
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Argentina ANMAT |
National Administration of Drugs, Foodstuffs and Medical Technology | |
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Mexico ANMAT |
Ministry of Health | |
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Colombia IN√IMA |
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Peru DIGEMID |
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CHINA NMPA |
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Japan's Ministry of Health, Labor and Welfare (MHLW) |
Foreign Manufacturer compliance with GMP | |
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