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THAILAND: Food and Drug Administration Announcement Regarding Technical Documents Preparation for Inspection Purpose 2020 – November,2020

THAILAND: Food and Drug Administration Announcement Regarding Technical Documents Preparation for Inspection Purpose 2020 – November,2020

  • 2020-11-26 01:31:52

Thailand is currently gearing up a step closer toward the transition of Thailand future regulation from Policy – based Classification to Risk-based Classification as Thailand’s Food and Drug Administration announced that it is mandatory for importer to prepare Technical Documents (CDST Dossier) upon importation by the period as follows : 1) Class 1, 2 and 3: 13 June 2021. 2) Class 4: 11 September 2021. Licensee who fails to comply with ThaiFDA must be sentence to penalty condition is as follows:
1. Licensed and Notified Medical Device: Shall be liable to imprisonment for a term not exceeding 1 year or fine not exceeding 100,000 THB or both.
2. General Medical Device: Shall be liable to imprisonment for a term not exceeding 6 months or fine not exceeding 50,000 THB or both.

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THAILAND: Food and Drug Administration Announcement Regarding the Document Preparation for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal – October, 2020

THAILAND: Food and Drug Administration Announcement Regarding the Document Preparation for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal – October, 2020

  • 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

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THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020

THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020

  • 2020-09-15 08:44:25

Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.

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