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TAIWANThe medical device regulatory approval process

* Non-US manufacturers must have ISO 13485 certification prior to submitting QSD registration. ISO 13485-compliant registrants must submit QMS documentation, product manufacturing information and manufacturing facility data. QSD reviews can take up to four months.

© 2013 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 10/2013.

© 2013 Emergo Group Inc. – All Rights Reserved

Determine classification of your device according to the Regulations Governing Management of Medical Devices (Article 2) published by The Taiwan Food and Drug Administration (TFDA). Taiwan’s classification system is based on the system used by the US Food and Drug Administration.

Class I Class II Class III

Appoint a Taiwan Agent Representative (Taiwan Agent) if you have no established business entity in Taiwan. Your Taiwan Agent manages your device registration and interacts with the TFDA on your behalf.

Prepare Quality System Documentation (QSD) application showing compliance with FDA QSR (21 CFR Part 820) or ISO 13485. Submit proof of compliance to TDFA for review. Class I devices that do NOT require QSD are listed in Article 2. Other others require QSD.

TFDA will review your documentation then issue a QSD certificate valid for three years.*

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 your registration application for submission to TFDA.

Prepare your registration application and dossier, including device information, product test reports and clinical testing data (if applicable). Testing conducted outside

Taiwan is usually accepted by TFDA, and product testing in Taiwan is not required.

All documents must be submitted in traditional Chinese or English.Pay application fee. TFDA reviews your registration application, and may request additional information.

5165-1113

Class II and III devices that include materials or technologies novel to the Taiwanese market are subject to a “new device” review including a Technical Committee Review.

If TFDA approves registration of your device, you will be issued a Medical Device Permit License and may begin marketing your device in Taiwan. Registration is valid for five years, and renewal documents must be submitted six months before expiration.

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NOTE: The time frames shown above are typical for the majority of medical device submissions prepared by Emergo Group but assume that your device does not contain animal tissue or medicinal substances. Your length of approval will depend on the quality and completeness of technical documentation used in the submission, additional requirements/questions from the TFDA after submission, and how much time you take to address additional information requests. Also, while many Ministries of Health publish internal goals for registration review time frames, those should generally be viewed as “best case” scenarios and often reflect working days, not calendar days. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.

* Some Class I devices do not require a Quality Systems Documentation (QSD) letter, a required element of the registration process. The TFDA often takes 4-5 months to review QSD documentation.

** New/high risk devices are any Class II or III devices that employ a material, technology or intended use that is unique to Taiwan.

© 2013 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 08/2013.

© 2013 Emergo Group Inc.

Average time from submission of required registration documents until approval is officially granted by the TFDA. 1

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CLASS I EXEMPT*

CLASS I

CLASS II

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NEW/HIGH RISK** ** ** ** ** **

= Period during which approval may occur.

TAIWANTypical approval time frames for imported medical devices