The Ministry of Public Health (MOPH) of Thailand issued a draft announcement to specify medical devices that are prohibited from direct selling or direct marketing businesses under the Direct Selling and Direct Marketing Act. The list of medical devices included in this draft announcement is as follows: Ophthalmic Viscosurgical Device
The secretary of the Thailand Food and Drug Administration (TFDA) issued a draft announcement as per the statement mentioned in section 21, paragraph 3 of the Medical Devices Act B.E. 2551, regarding notification of possession, movement, inspection of readiness, and costs of medical devices that require technology assessment. This announcement
On 30 December 2023, the Vietnam Ministry of Health (MoH) issued Dispatch 8329/BYT-HTTB to the Local Health Department, requesting for the review on the implementation of the declaration of applicable standards within the area. This is due to the MoH receiving information that manufacturers or importers of medical devices have
The Philippines Food and Drug Administration (FDA) issued an advisory No. 2024-0009, dated 10 January 2024, regarding Revision in the Process of Application for Certificate of Medical Device Registration (CMDR) / Certificate of Medical Device Notification (CMDN), Initial and Renewal. There are a few key points highlighted in the FDA
Thailand FDA released several announcements related with the medical devices, as follows: 1. Deadline for submitting documents in Full CSDT As of 15 February 2024 onwards, anyone who wishes to submit license applications (for Class 4 or Class D) or notification applications (for Class 2 & 3 or Class B
On 02 January 2024, the Vietnam Ministry of Health issued Decision No. 04/QD-BYT which elaborated that the appraisal of the submitted CSDT (Common Submission Dossier Template) for the purpose of medical device registration, will be conducted by the appointed third-party agencies as follows: For non-in vitro medical devices: Institute of
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