WORLD TRADE G/TBT/Notif.97.782
30December 1997
ORGANIZATION
(97-5614)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: THAILAND
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: TheFood andDrug Administration, Ministry ofPublic Health
Agency orauthority designated tohandle comments regarding thenotification shall be
indicated ifdifferent from above: Thai Industrial Standards Institute, Ministry of
Industry
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Implanted silicone breast
prothesis
5. Title, number ofpages andlanguage(s) ofthenotified document: TheNotification of
thePublic Health No.23B.E.2540 (1997) onImplanted Silicone Breast Prothesis
6. Description ofcontent: Implanted silicone breast prothesis isconsidered amedical
device. Manufacturers andimporters ofsuchproduct must submit detailed information
totheMinistry ofPublic Health andtheproducts themselves must beaffixed withthe
labelgiving thefollowing information inThailanguage:
1. Name, category andtypeoftheproduct;
2. name andaddress ofmanufacturers orimporters;
3. volume;
4. batch orlotnumber;
5. manufacturing andexpiry date;
6. record number ofsubmission totheMinistry ofPublic Health;
7. indication ofusage, maintenance instruction;
8. precaution andwarnings, asappropriate;
9. thestatement "Forsingle use"written inredcolour;
10. thestatement "Implanted silicone breast prosthesis must beused bymedical
professional personnel" written inredcolour.
./.G/TBT/Notif.97.782
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7. Objective andrationale, including thenature ofurgent problems where applicable:
Consumer protection
8. Relevant documents: TheMedical Device Act,B.E.2531 (1988)
9. Proposed dateofadoption:
Proposed dateofentry intoforce:30March 1998
10. Final dateforcomments: -
11. Texts available from: National enquiry point [X]oraddress, e-mail andtelefax number
ofother body: