Easy to understand chart describes the medical device registration process with the TFDA in Taiwan.

1. Taiwan
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 09/2016. EmergoGroup.com/taiwan
Medical devices are regulated by the Pharmaceutical Affairs Act and the Regulations for Governing the Management of Medical
Devices, as published by the Taiwan Food and Drug Administration (TFDA).
Determine classification of your device according to the device database.
Taiwan’s classification system is similar to the system used by the US Food and Drug Administration.
Appoint a Taiwan Agent to manage your device registration and interact with the TFDA on your behalf.
Your Taiwan Agent must have a legal entity established in Taiwan, certified with a Pharmaceutical Sales License.
Prepare Quality System Documentation (QSD) application. Provide ISO 13485 certificate.* Submit application to TFDA for review and
pay QSD registration fee. Certain non-sterile Class I devices are exempt from QSD registration; refer to Annex II of the Regulations.
TFDA will review your documentation and upon approval issue a QSD Approval Letter which is valid for three years.
Pay application fee. TFDA reviews application and may request additional information.
Devices which include materials or technologies novel to the Taiwanese market, as well as products which meet the criteria for
‘High Risk Medical Devices’ are subject to a TFDA Medical Device Committee Review.** Clinical trial information will be required
unless the device is Class II and qualifies for the Simplified Application Route noted above.
Upon TFDA approval you will be issued a Medical Device Product License valid for five years.
Renewal documents must be submitted six months before expiration.
Appoint a licensed distributor and have your Taiwan Agent file an authorization application with the TFDA to import your
products. After the distributor receives the approval letter from the TFDA, you may begin marketing your device in Taiwan.
Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG)
proving your device is approved for sale in the country where your company is based.
Prepare registration application for
submission to TFDA. Documents include:
product information such as labeling and
IFU (translated to Chinese) and proof of
QSD application submission (if required).
Prepare registration application and dossier. Documents include copies of labeling
and IFU (translated to Chinese), device information, proof of QSD application
submission, product testing reports, and preclinical testing data (if applicable).
Testing conducted outside Taiwan is usually accepted by the TFDA. (Class I and II
devices approved for sale in the US and Europe qualify for a Simplified Application
Route and do not require a review of preclinical testing results by the TFDA.)
Class I Class II Class III
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The Regulatory Process for Medical Devices
* US manufacturers without ISO 13485 certification may show proof of FDA QSR compliance.
** The TFDA Medical Device Committee Review for novel or high risk devices will add an additional 8 months to the approval timeline. Ask us for details.
This is a simplified overview of the process. The TFDA may choose to audit your submission and request more documents, which will add time to your approval.

2. Taiwan
Notes
1. The time frames shown are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, or medicinal
substances. New or high risk devices will undergo a TFDA Medical Device Committee Review, which will add an additional 8 months to the above timelines.
Your length of approval will depend on the quality and completeness of your technical documentation and how much time you take to address additional
information requests from the TFDA after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.
2. Registrations remain valid for the time specified as long as you do not make changes to the device, intended use, or indications for use. Quality System
Documentation (QSD) approval letters expire after 3 years. Renewal requirements are the same as a new application, and may be filed a year prior to the
certificate’s expiration.
3. We recommend starting the re-registration process no later than the time period specified above. However, please consult with your distributor or
regulatory expert well before this suggested time to avoid any lapse in your registration.
4. Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who
were asked to rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other
markets are compared.
5. Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing,
in-country representation, submission preparation consulting and translation of registration documents but not IFU. Costs assume you already have
approval for your device in the United States, Europe, Canada, or Japan. Not included is the cost of implementing or auditing a quality management system
compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable.
EmergoGroup.com/taiwan
Device classification
category
Class I Class II Class III
How long you should
expect to wait after
submission until
approval is granted1
1-2 months 10-12 months 10-12 months
Validity period for
device registrations
and QSD2
5 years (device)
3 years (QSD)
5 years (device)
3 years (QSD)
5 years (device)
3 years (QSD)
Registration renewal
should be started this
far in advance3
10 months 10 months 10 months
Complexity of the
registration process
for this classification4
Overall cost of gaining
regulatory approval5
5165-0916
Low High
Simple Complex
Low High
Simple Complex
Low High
Simple Complex
© 2016 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 09/2016.
Time, Cost, and Complexity of Registration
This is a simplified overview of the process. The TFDA may choose to audit your submission and request more documents, which will add time to your approval.