EmergoGroup.com/taiwan Learn more about Taiwan: TAIWAN The 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 [email protected]. 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.