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The note of “Application for personal use importation” 【發布日期:2018-11-15】 發布單位:醫療器材及化粧品組

According to 「Regulations governing management of samples and gifts」Article 2 Subparagraph 4、Article 6 and Article 14.
Individuals may import a medical device with a prescription from a domestic licensed physician for personal use into the R.O.C., or a foreign citizen may import a medical device with a foreign prescription and diagnosis statement from the original hospital/clinic which identified by the central competent health authority of R.O.C. besides a medical device which should operated by a licensed physician or professionals.
According to 「Regulations governing management of samples and gifts, Article 6 and 14」, the following documents shall be submitted for review:
Article 14:
1. The recipient of International Parcel Claim or customs bill of lading(B/L) is the same as the patient.
2. Package、instructions、labeling or catalog of the product.
3. A “Declaration” which is written with following statement: 「The approval sample will not be sold, transferred and transferred for treatment of other patient.」
4. A prescription from a domestic licensed physician or a foreign prescription and diagnosis statement from the original hospital/clinic which identified by the central competent health authority of R.O.C. (The name, brand, model number and amount of the medical device should be written.)
5. Form of Application for import certificate
6. A copy of personal ID
 

 
The note of “Application for personal use importation”
http://www.fda.gov.tw/TC/siteListContent.aspx?sid=2230&id=25409
I. Medical device consultation hot-line:02-2787-8200, 02-81706008
II. Form of Application for import certificate
1. 「Declaration of medical device importation for personal use」
(1) The name, brand, model number (specification) and amount of the medical device should be written.
(2) The signature, personal ID number, contact number, contact address, the date of signature should be written.
(3) Additional information should be provided with hand-write declaration:
a. The medical device permit license is not approved and issued by MOHW (Ministry of Health and Welfare), R.O.C., the applicant cannot apply for injury relief if there is any adverse event. Please aware and carefully consider that the applicant is responsible for the safety of the medical device (the physician who issued the prescription and the applicant are responsible for the efficacy and safety of the medical device).
b. A guarantee that the medical device is for personal use only.
c. The applicant will not sold, transfer and transfer the medical device for treatment of other patient, and is responsible for the safety of the medical device.
d. The applicant writes down this「Declaration of medical device importation for personal use」, in order to provide above information.
2. 「APPLICATION FOR IMPORT CERTIFICATE」(three copies):
(1) The recipient of International Parcel Claim or customs bill of lading(B/L) is the same as the patient.
(2) The item 8: The name, brand, model number (specification), the manufacture’s name and address of the medical device should be written.
(3) The signature of applicant should be signed on the bottom right corner of the first application form copy.
III. The prescription from a licensed physician for personal use importation should include following information:
1. The name of disease
2. A statement “the applicant has ________(disease name) and needs this medical device﹝information includes the name, brand, model number (specification) and amount of the medical device﹞which no need to be operated by a licensed physician or professionals.
IV. the following documents shall be submitted for review:
1. 「Declaration of medical device importation for personal use」
2. 「APPLICATION FOR IMPORT CERTIFICATE」(three copies):
3. A prescription from a domestic licensed physician or a foreign prescription and diagnosis statement.
4. An international Parcel Claim or customs bill of lading (B/L)
5. A copy of personal ID (front and back)
6. Information of the medical device (in Chinese or English): can be the package, labeling, instruction of use or operation manual ﹝information includes the name, brand, model number (specification) ,amount, the manufacture’s name and address of the medical device﹞.


Please send the all documentations to
No.161-2, Kunyang St, Nangang District, Taipei City 115-61, Taiwan (R.O.C)