FAQ
Medical Devices

As a general consumer who had difficulty acquiring suitable medical devices in Taiwan for personal medical needs. Is it available to purchase medical devices online from foreign country and import them into Taiwan?

刊登日期:2019-07-11  |  點閱次數 : 100 次 

If a general consumer intends to import medical devices for personal use, they must submit a “Special Import of Medical Device for Personal Use” application to the Taiwan Food and Drug Administration (TFDA). The documents that should be attached to such an application are: 

(1) An Assurance Statement of Medical Device Application for Personal Use(Chinese version only).

(2) A Triplicate Application Form for An Import Certificate(Chinese version only).

(3) A diagnosis certificate and a prescription issued by a doctor:

The prescription should state the following information: (a) name of the disease; (b) an explanatory statement with the following format “the application of medical device xx is required for disease xx. The medical device must come in the quantity xx and specification xx (can be substituted by the product name or model).” A statement indicating that “the medical device does not need to be operated by a doctor or a medical professional” or “the medical device can be operated by the patient” should also be added.

(4) A photocopy of the international parcel claim document or customs claim document:

If the name of the recipient is printed in English on the document, please also provide a copy of a relevant identity document (e.g., a passport photocopy) for name verification purposes.

(5) A copy of the back and front of the applicant’s National Identification Card:

If a family member is making the application on behalf of the applicant, a photocopy of the National Identification Card of both parties or a photocopy of their household certificate is required for relationship verification.

(6) Information about the medical device:

The outer packaging box of the medical device and the package insert or instruction manual (the content of the manual should include name, specification, usage, brand, manufacturer of the device, and other relevant information).   

Please send the attached documents for application to the following address:

Food and Drug Administration, Ministry of Health and Welfare,
No. 161-2, Kunyang Street, Nangang District, Taipei City, 115, Taiwan (R.O.C).

Please click on the following link to download the relevant forms:
Application for personal use importation

For further details, please refer to website for further details:
Precautions and Attachments Related to Application for Medical Devices for Personal Use.

 

(中文版)


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