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Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs

All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA).

Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs

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All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA). All classes of medical devices require pre-market approval prior to Taiwanese market entry. Download the chart using the form below.

The Taiwan TFDA medical device approval process explained

The chart shown illustrates the TFDA approval process in Taiwan and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

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).

Step 1
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. Classes are divided into Class I, Class II, and Class III.

Step 2
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.

Step 3
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.

Step 4
TFDA will review your documentation and upon approval issue a QSD Approval Letter, which is valid for three years.

Step 5
For Classes II and III, 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.

Step 6
For Class I: Prepare registration application for submission to TFDA. Documents include: product information such as labeling and IFU and QSD Approval Letter (if required).

For Classes II and III: 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 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.)

Step 7
Pay application fee. TFDA reviews application and may request additional information.

Step 8
Devices that include materials or technologies novel to the Taiwanese market (i.e., 'New Devices'), as well as products that 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.

Step 9
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.

Step 10
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.

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.

* US manufacturers without ISO 13485 certification may show proof of FDA QSR compliance. Japanese manufacturers have the option to alternatively provide their inspection report and QMS certification from the PMDA or RCB (as applicable). There is also an on-site audit option available to manufacturers without ISO 13485 certification, though it is subject to a much higher fee.

** 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.

Chart Updated: 07/2019