Food and Drug Administration has arranged and announced a set of documentation required for Seller's License renewal that will expire on December 31st, 2020. Seller’s Licensee shall refer to this license renewal statement letter and prepare documents accordingly to prevent any mistakes while submitting leading to an efficient submission.
More 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.
Food and Drug Administration urgently announced certain control measures for powdered surgical gloves regarding the technical issues of the powder used in manufacturing process which may cause serious adverse effect to end-users or patients.
More 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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MDCO will conduct a trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conforms with Hong Kong requirement by using marketing approvals obtained from the China Food and Drug Administration.
More On November 16th of 2017, Philippine Food and Drug Administration (FDA) announced that the importation and exportation of radiation devices that can be ionizing and non-ionizing shall not be allowed to enter the country unless a Clearance for Customs Release (CFCR) has been issued by the Center for Device Regulation,
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