November 2023

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Malaysia: Exploring Registration Options: MDA’s Guidelines for IVD Analyzer Registration

On November 16, 2023, the Medical Device Authority of Malaysia (MDA) published an infographicrelated to the medical device registration for In-Vitro Diagnostic (IVD) Medical Devices, where theMDA illustrated the possible ways to register an IVD Analyzer.Based on the infographic, the approaches below can be applied to register an IVD Analyzer:1) IVD AnalyzerThis applies to instruments […]

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Malaysia: MDA’s Medical Device Advertisement Application Transitions to Paperless Starting December 2023

On 8th November 2023, the Medical Device Authority of Malaysia (MDA) published an announcement related with medical device advertisement applications. Commencing December 1st, 2023, the medical device advertisement applications can only be submitted to the MDA via email at advertisement@mda.gov.my. Any hard copies applications will not be processed by MDA. Processing fees shall be paid

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Malaysia: MDA Announces Harmonized QMS Standards for Medical Device Registration in 2024

Based on the Decision from the Mesyuarat Jawatankuasa Teknikal Pendaftaran Umum 2023, the Medical Device Authority of Malaysia (MDA) has established a transition period for specific requirements until December 31, 2023. Starting January 1, 2024, only the recognized Quality Management System (QMS) standards outlined in Table 1 will be accepted for new and re-registration of

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Malaysia: Implementation of the use of Electronic Medical Device Registration Certificate in Malaysia

On 26th October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement on the implementation of the use of electronic medical device registration certificate beginning November 1, 2023. With this move for applications approved after 1 November 2023, only electronic medical device registration certificates will be issued by MDA. Instead, the establishment can

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Malaysia: The MDA To Cease The Issuance Of Certificate Of Free Sale (CFS) For Export Only Medical Device

On 23rd October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement that the Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by the Chief Executive of MDA during MDA High Performance Project on 7th June 2023. With this move, MDA ceases the issuance

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Singapore: Public Comments on Revised Draft of GN-20: Guidance on Clinical Evaluation

The Health Sciences Authority (HSA) Singapore revised Guidance Document: GN-20 Guidance on Clinical Evaluation. The updates reflect their current position on the use of real-world data in medical device clinical evidence as well as clarify related contents with IMDRF guidelines.  The HSA is currently soliciting industry comments for this revision. This drafted document provides major

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Thailand: Guideline for Submission of Application to Import Under Special Access Under Section 27 in Thailand

On October 18th, 2023, the Thai Food and Drugs Administration (FDA) provided more explanation to the registration of medical devices scheme, by issuing a pamphlet that can be accessed here (in Thai language). The pamphlet emphasizes more on the registration process based on the risk classification of the medical devices, in which registration of accessories

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Indonesia: Procedure on Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Medical Devices in the Sectoral e-Catalogue of the Ministry of Health of Indonesia

On October 18, 2023, the Bureau of Goods and Services Procurement (or known as ‘PBJ Bureau’) of the Ministry of Health conducted a socialization on the implementation of Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Medical Devices in the Sectoral e-Catalogue, in an effort to improve and increase the use of

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Vietnam: New Process for the Registration Application of Class C and D Medical Devices

New Process for the Registration Application of Class C and D Medical Devices in Vietnam The Vietnam Ministry of Health posted on the DMEC website on the 10th of October 2023 regarding the new reception and registration process of Class C & D medical devices. Accordingly, the pre-assessment process for Class C and D applications

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Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services

The Philippines Food and Drug Administration held a virtual public consultation on the draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services”, October 27th 2023. The aim of the proposed draft issuance is to rationalize the

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Singapore: New Revision of the Medical Devices Product Classification Guide

On October 2nd, 2023, the Health Sciences Authority of Singapore (HSA) issued a second revision of GL-06: Medical Device Product Classification Guide. This guidance document is applicable to all medical device dealers namely registrants, manufacturers, importers, and distributors. The main highlights of the updated guidance document include the following: To include Eye drops or Eye

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