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Malaysia: First Edition Guidance Document on Importation of Medical Devices for Re-Export (IRE)

On March 11, 2025, the Medical Device Authority (MDA) of Malaysia released the First Edition Guidance Document MDA/GD/0069 titled “Importation of Medical Devices for Re-Export (IRE).” This document provides clarity on the procedures and requirements for importing medical devices into Malaysia for re-export purposes, covering aspects such as approvals, exemptions, and compliance obligations. Key Highlights […]

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Indonesia: Temporary Closure of Licensing System During Eid al-Fitr 1446 H Joint Leave

The Ministry of Health of Indonesia has announced a temporary closure of the medical device and Household Health Device (PKRT) licensing system in observance of the Eid al-Fitr 1446 H holiday and collective Joint Leave. From March 28 to April 7, 2025, the following systems will be temporarily unavailable: Medical Device Licensing System: https://regalkes.kemkes.go.id/ Other

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Philippines: FDA Temporarily Suspends CDRRHR Telephone Lines Due to Facility Maintenance

The Food and Drug Administration (FDA) announces that the telephone numbers for the Center for Device Regulation, Radiation Health, and Research (CDRRHR) are suspended from March 4, 2025, to March 28, 2025, or until the completion of necessary roofing installation at their facilities.  Alternative Contact Methods During this period, stakeholders and the public are advised

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Singapore: Public Consultation on Best Practices Guide for Medical Device Cybersecurity

The Health Sciences Authority (HSA) of Singapore has released a draft guidance document titled Best Practices Guide for Medical Device Cybersecurity for industry stakeholders’ consultation. Key Highlights Scope and Purpose: Intended for medical device manufacturers and healthcare providers. Establishes general cybersecurity principles, particularly advocating for a “Secure by Design” approach during the software development phase.

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Singapore: Missing Safety Alerts for Smartphone-Compatible Diabetes Devices

The Health Sciences Authority (HSA) Singapore has issued an advisory to users of app-enabled medical devices, including continuous glucose monitors (CGMs), insulin pumps, automated insulin dosing systems, and other diabetes devices. This advisory is based on overseas cases where notification alerts failed to activate on users’ smartphones during glucose and/or insulin level fluctuations, potentially leading

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Philippines: Notice of Virtual Public Consultation on Good Storage and Distribution Practices for Medical Devices

On March 27, 2025, the FDA, through the Center for Device Regulation, Radiation Health, and Research (CDRRHR), will hold a Virtual Public Consultation to present the proposed Administrative Order (AO) titled “Guidelines for Good Storage and Distribution Practices for Medical Devices.” The consultation will be conducted via Microsoft Teams and will be open to representatives

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Philippines: New Email Addresses for Health Product Recalls Announced by FDA

On March 3, 2025, the Food and Drug Administration (FDA) issued FDA Advisory No. 2025-0139 announcing new email addresses for submitting notifications and reports on health product recalls. Market Authorization Holders (MAHs) must promptly notify the FDA and submit the necessary reports and information to the Food and Drug Action Center (FDAC) at info@fda.gov.ph. Additionally,

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Philippines: Reiteration of Contact Details and Process for Feedback, Complaints, and Specific Concerns to the Food and Drug Administration

On March 3, 2025, the Food and Drug Administration (FDA) issued Advisory No. 2025-0140, reiterating the official contact details and the process for submitting feedback, complaints, and specific concerns. This aims to ensure that all communications are directed to the appropriate departments for timely and proper responses, as referenced in FDA Circular 2020-2026. Feedback and

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Indonesia: Amendments to the Regulation on Radio Frequency Spectrum Use Under Class Permits

  The Ministry of Communication and Digital has updated the Minister of Communication and Informatics Regulation Number 2 of 2023 concerning the use of radio frequency spectrum based on class permits. The followings are the highlighted amendment: 1. Radiofrequency spectrum based on class permits for a group of telecommunications equipment and/or telecommunication devices. Changes are

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Philippines: Interim Extension of Renewal Application Filing Period for License to Operate (LTO)

The Food and Drug Administration (FDA) of the Philippines has announced an extension to the renewal application filing period for the License to Operate (LTO), as detailed in FDA Advisory No. 2025-0095.  Effective February 17, 2025, stakeholders may submit renewal applications 180 days before their LTO expiration date, replacing the previous 90-day requirement. This interim

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Malaysia: Implementation of Medical Device Regulations on Compounding of Offenses

On January 15, 2025, the Medical Device Authority (MDA) will begin implementing compounding of offenses under the Medical Device Act 2012 (Act 737). This enforcement is based on the authority granted under Section 71 of Act 737 and the Medical Device (Compounding of Offenses) Regulations 2024, which were officially gazetted last year. Key Highlights Objective

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Thailand: New Guidelines for Change Notification of Medical Device Item Addition or Reduction for Notified and Licensed Non-In Vitro Diagnostic Devices

On February 10, 2025, the Thai Food and Drug Administration (FDA) released updated guidelines for submitting change notifications related to the addition or reduction of medical device items for non-in-vitro diagnostic (non-IVD) medical devices. These guidelines outline the required documentation for various types of change requests and took effect on January 15, 2025. Key Highlights

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Philippines: FDA Introduces Over-the-Counter (OTC) Payment System for All Applications and Transactions

On February 10, 2025, the Food and Drug Administration (FDA) of the Philippines implemented an Over-the-Counter (OTC) payment system for all FDA applications and transactions. This initiative aims to streamline the payment process, providing greater convenience for stakeholders. Key Highlights 1. OTC Payment Availability and Appointment Requirement OTC payments will be accepted at the FDA

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Malaysia: Transition to Online Advertising Application Process in Malaysia

The Medical Device Authority (MDA) of Malaysia has announced that, starting March 1, 2025, all medical device advertisement applications must be submitted exclusively online via Google Forms. This transition aims to enhance efficiency, streamline submissions, and improve the applicant experience. Key Changes in the Application Process Mandatory Online Submission Beginning March 1, 2025, all advertisement

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Thailand: New Thai FDA Guidelines for Change Notification in In Vitro Diagnostic (IVD) Medical Devices

On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) issued new Change Notification Guidelines for Notified and Licensed In Vitro Diagnostic (IVD) Medical Devices. These guidelines outline updated regulatory requirements and take effect from January 15, 2025. The full announcement is available on the Thai FDA Official Website (กองควบคุมเครื่องมือแพทย์) [in Thai]. Key

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Thailand: Medical Device Control Division Implements Improved Change Notification System

The Medical Device Control Division has introduced an updated Change Notification System for medical devices in Thailand, effective January 15, 2025. The newly issued guideline regulates the increase or decrease of medical device items within the same medical device group without affecting their category classification. This guideline has been published under the authority of the

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Philippines: Temporary Suspension of Pre-Assessment Fees for Select FDA Applications Amid Implementation of AO No. 2024-0016

On January 24, 2025, the Food and Drug Administration (FDA) of the Philippines announced the temporary suspension of pre-assessment fees for specific applications, as outlined in FDA Advisory No. 2025-0076. This decision aims to address challenges in implementing Administrative Order (AO) No. 2024-0016, which establishes a new schedule of fees and charges. Key Highlights Temporary

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Malaysia: Draft Guidance Document for Public Comments: Importation of Medical Device for Personal Use – Second Edition

On January 22, 2025, the Medical Device Authority (MDA) of Malaysia released a draft guidance document for the second edition of Importation of Medical Device for Personal Use (MDA/GD/0066). This document outlines the procedures for individuals seeking to import unregistered medical devices into Malaysia for personal use. Applicants may request a confirmation letter from the

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Thailand: Thai FDA Releases Draft Announcement on Medical Devices for Personal Use Exempt from Medical Certification

The Thai Food and Drug Administration (Thai FDA) has amended its announcement regarding the importation of medical devices in quantities necessary for personal use, under Section 27(5) of the Medical Device Act B.E. 2551 (2008). The new draft, B.E. 2567 (2024), specifies conditions under which certain medical devices are exempt from requiring a medical certification

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Thailand: Thai FDA Issues Guidelines for Medical Device Sellers

The Thai Food and Drug Administration (Thai FDA) has released new guidelines for medical device sellers operating in Thailand. Effective immediately, these guidelines outline the necessary steps for compliance with regulatory requirements, including obtaining a sale license where applicable. Key Steps for Medical Device Sellers Step 1: Determine Whether a Sale License is RequiredMedical device

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Vietnam: Enterprises Declaring Medical Device Prices at the Ministry of Health

On December 31, 2024, the Vietnam Ministry of Health issued Notice No. 638/TB-HTTB, announcing the list of enterprises declaring medical device prices at the Ministry of Health. The list has been compiled under the provisions of Decree No. 85/2024/ND-CP, dated July 10, 2024, which outlines detailed regulations in the Law on Prices. The updated list

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Vietnam: Extension on Medical Device Import Licenses

On January 1, 2025, the Government of Vietnam issued Decree No. 04/2025/ND-CP, amending and supplementing several articles of Decree No. 98/2021/ND-CP regarding the management of medical devices. The decree extends the validity of medical device import licenses as follows: Import licenses for medical devices issued from January 1, 2018, to December 31, 2021, remain valid

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Indonesia: Expiration of Director General Decree No. 109/2024 on Foreign Test Centre Designation

The Director General of Posts and Information Resources and Equipment Decree No. 109/2024, regarding the recognition of Foreign Test Centres for Telecommunication Device Certification, expired on December 31, 2024. As of January 1, 2025, Test Result Reports issued by these Foreign Test Centres are no longer valid for the Certification Process unless the centres are

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Medical Device Authority (MDA) Shared 2025 Plans via Facebook Live Event on January 14, 2025

The Medical Device Authority (MDA) of Malaysia hosted a Facebook Live event on January 14, 2025, titled “Chief Executive New Year Message: What’s Beyond 2025”. Delivered by the MDA Chief Executive, the session highlighted key regulatory and developmental plans for the coming years. Key Highlights from the Facebook Live Event Development of MedCast 3.0 MedCast

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Indonesia: Implementation of Electronic Catalogue Version 6 for Procurement of Goods and Services

On January 1, 2025, the Republic of Indonesia will officially implement Electronic Catalogue Version 6 for the procurement of goods and services, in accordance with a directive from the President of the Republic of Indonesia. As part of this transition, Electronic Catalogue Version 5 will be deactivated on December 31, 2024, except for specific categories

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Singapore: HSA Introduces Change Management Program (CMP) for SaMD, Including Machine-Learning Enabled SaMD

The Health Sciences Authority (HSA) of Singapore has issued a new guidance document, GN-37-R1 Change Management Program (CMP) for SaMD, Including Machine-Learning Enabled SaMD, effective December 4, 2024. This guidance introduces an optional regulatory pathway designed to streamline regulatory processes for software as a medical device (SaMD) manufacturers, particularly those incorporating machine learning. Key Highlights

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Thailand: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025)

On December 4, 2024, the Thai FDA announced revisions to the regulations governing medical device advertising. These updates, outlined in the “Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025)”, aim to enhance clarity and ensure alignment

Thailand: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License Validity for Medical Device Advertising B.E. 2568 (2025) Read More »

Indonesia: Update on Listing Product Schedule in the Ministry of Health e-Catalogue

The Ministry of Health (MoH) of Indonesia has announced an update regarding the listing of medical device products in the e-Catalogue managed by the National Public Procurement Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah). This update affects stakeholders who sell their medical device products through the government purchasing system. Extended Deadline for Product Listing The

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