OCTOBER 23
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MDCD Overview
Medical Device Control
in Thailand
Medical Device Law
 


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Medical Device Control in Thailand
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Medical Device Control Division , Thai - Food and Drug Administration, is an organization which regulates and monitors Quality, Standard, Efficiency and Safety of medical devices manufactured, imported and sold in Thailand abide by Medical Device Act B.E. 2531 ( A.D. 1988 ), Ministerial Regulation and Notice of The Ministry of Public Health

Currently, Medical devices in Thailand are classified into 3 groups by following :
I. Licence Medical devices - In this group of medical device, all related entrepreneurs(i.e. manufacturer, importer and seller ) must have their medical devices approved to get licence by Thai - Food and Drug Administration prior to making business in Thailand comply to Ministerial Regulation No. 1 - 3 (B.E. 2533) . Licence Medical devices must follow the quality and standard stated in related Notice of The Ministry of Public Health comprising of
CONDOM
EXAMINATION GLOVE
SURGICAL GLOVE
HYPODEMIC SYRINGE
INSULIN SYRINGE
HIV TEST KIT ( for diagnostic use )
In addition, Licensee must follow to section 29-32 of Medical Device Act B.E. 2531 ( A.D. 1988 ) and Ministerial Regulation No

II. Notification Medical devices - Related entrepreneurs must notify their medical device to Thai - Food and Drug Administration following to Ministerial Regulation No. 4 . This group of medical devices composes of
HIV TEST KIT ( for other purposes )
PHYSICAL THYRAPY PRODUCTS
ALCOHOL DETECTOR
IMPLANTED SILICONE BREAST PROSTHESIS

III. General Medical devices - This group of medical device is excluded from group I and group II. Only Importer must submit certificate of freesale which is issued by Government or approval private organization to get approval by Thai- Food and Drug Administration in order to manifest at Customs process following to Notice of The Ministry of Public Health No. 6 ( B.E. 2532 )





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