Regulatory updates Archives

Thailand: Draft Announcement on Notification of Possession, Movement, Inspection of Readiness, and Costs of Medical Devices that Require Technology Assessment

January 31, 2024

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

Vietnam: Inspection And Review Of The Declaration Of The Applicable Standard Procedure In Vietnam

January 29, 2024

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

Philippines: Revised Process Of CMDR / CMDN Initial And Renewal Application

January 29, 2024

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: Announcement From Thailand FDA Regarding CSDT Applications, Annual Report Submission And Breathalyzers

January 29, 2024

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

Vietnam: Ministry Of Health Appoints The Units To Appraise The Common Submission Dossier Template (CSDT) According To ASEAN Regulations

January 29, 2024

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

Philippines: PFDA Released Draft Guidelines On The Recall Of Health Products

January 22, 2024

As part of the larger Post Market Surveillance (PMS) activity in the Philippines, the Food and Drug Administration (FDA) issued a draft on the Guideline for The Recall of Health Products. The main goal of the issuance of this draft guideline is to update the previously issued FDA Circular No.

Regulatory Updates

Thailand: Draft Announcement on Notification of Possession, Movement, Inspection of Readiness, and Costs of Medical Devices that Require Technology Assessment

Vietnam: Inspection And Review Of The Declaration Of The Applicable Standard Procedure In Vietnam

Philippines: Revised Process Of CMDR / CMDN Initial And Renewal Application

Thailand: Announcement From Thailand FDA Regarding CSDT Applications, Annual Report Submission And Breathalyzers

Vietnam: Ministry Of Health Appoints The Units To Appraise The Common Submission Dossier Template (CSDT) According To ASEAN Regulations

Philippines: PFDA Released Draft Guidelines On The Recall Of Health Products

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