December 2023

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Malaysia: MDA Issued Two Updated Guidance Documents on Harmonised Classification and Borderline Products in ASEAN 

On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows: MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition. These are the highlights of each regulation: Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062) Harmonised Borderline Products in ASEAN 2nd Edition […]

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Indonesia: List Of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories For Medical Devices And Household Supplies In Indonesia

On 5 December 2023, the General Director of Pharmaceuticals and Medical Devices of the Ministry of Health (MoH) of Indonesia released a circulation letter No: HK.02.02/E/2379/2023 regarding the List of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories for Medical Devices and Household Supplies. SNI itself is an abbreviation of Standar Nasional Indonesia or Indonesian National Standards.

Indonesia: List Of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories For Medical Devices And Household Supplies In Indonesia Read More »

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Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia

On 5 December 2023, the Ministry of Health (MoH) of Indonesia released an announcement letter No: FR.03.01/E.V/2510/2023 regarding the maintenance process of the MoH platform for online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the following changes will be applied:A.

Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia Read More »

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Indonesia: Procedure for the Implementation of Foreign Halal Certificate Registration by The Halal Product Guarantee Administering Agency (BPJPH) in Indonesia

Based on Law No. 33 of 2014 regarding Halal Product Guarantee, all foreign halal products imported into Indonesia do not require to apply for a local halal certificate, if the foreign halal certificate is issued by a foreign halal institution that has collaborated on mutual recognition of halal certificates with The Halal Product Guarantee Administering

Indonesia: Procedure for the Implementation of Foreign Halal Certificate Registration by The Halal Product Guarantee Administering Agency (BPJPH) in Indonesia Read More »

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Indonesia: Draft of Government Regulations concerning the Implementation of Law No. 17 of 2023 concerning Health in Indonesia

A draft of Government Regulations pertaining to the Implementation of Law No. 17 of 2023 concerning Health was uploaded on the Ministry of Health of Indonesia official website. This regulation was derived from Law No. 17 of 2023, in which one of the clauses mentioned that the further implementation of the law will be regulated

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Philippines: PFDA Issued a Draft Guidance Documents on CMDN Initial Application via FDA eServices Portal System

PFDA issued a circular draft for comments regarding the guidelines on the use of the eServices portal system for the initial application of Certificate of Medical Device Notification (CMDN) in line with the PFDA’s goal of delivering efficient government services. Currently, CMDN applications are transacted via the ePortal System. Migrating the mentioned transaction to the

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Singapore: HSA Shares Revisions on Change Notification Guidelines Following EU MDR and IVDR Changes

On November 20, 2023, the Health Sciences Authority (HSA) Singapore revised the guidance document on Change Notification applications due to EU MDR and IVDR-related changes to registered medical devices. The identified changes clarified in this update are the following: Changes to IFU related to clarification of existing content and addition of safety information (GMD and

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Vietnam: Ministry of Health Releases Circular to Repeal Existing Regulations

On 14 November 2023, the Vietnam Ministry of Health released Circular 20/2023/TT-BYT repealing some legal regulations issued by the Ministry of Health. By January 1, 2024, the following regulations will be completely revoked: Regulation Regulation Date Provision Directive No. 06/2008/CT-BYT June 27, 2008 The enhancement of the quality of healthcare personnel training Decision No. 379/2002/QD-BYT

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