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

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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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Singapore

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Our Singapore team is at the forefront of product registration, post-market surveillance, and navigating customs regulations. With proficiency in English and Mandarin, and expertise in ISO 13485 standards, they provide comprehensive support to help clients succeed in a fast-changing regulatory landscape.

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Vietnam

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Our Vietnam team brings extensive expertise in the medical device sector, offering key insights into regulatory changes, product registration, and compliance monitoring. Fluent in Vietnamese, they ensure your business stays competitive and fully compliant in this fast-evolving market.

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Malaysia

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Our Malaysia team consists of regulatory and distribution experts, offering compliance solutions in both Bahasa Malaysia and English. With a proven history of successful product registrations and market launches, they bring deep insights into the local healthcare ecosystem. From consultation to approval, they provide comprehensive support through every stage of the regulatory process.

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Indonesia

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Specialising in product registration, post-market surveillance, and local compliance in Bahasa Indonesia, our local team is able to offer seamless market access minus the fuss. Our team has years of experience and deep understanding of Indonesia’s unique regulatory environment, which helps expedite the approval process and ensure that all regulatory requirements are met accurately and efficiently.

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Vietnam: Issuance of Draft Amendments and Supplements to the Decree on Medical Devices Management

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On December 20, 2024, the Vietnam Ministry of Health (MoH) issued a draft amendment and supplement to several articles of Decree No. 98/2021/ND-CP, dated November 8, 2021, on Medical Devices Management. This draft follows previous amendments introduced by Decree No. 07/2023/ND-CP, dated March 3, 2023. The draft aims to enhance regulatory processes while addressing key

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Indonesia: Notification of Dried Blood Spot Product Classification as a Medical Device

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On December 16, 2024, the Indonesian Ministry of Health issued Notification Letter No. FR.03.01/E.V/2672/2024, classifying Dried Blood Spot as a medical device. This update provides significant regulatory implications for manufacturers, importers, and distributors of the product. Below is a detailed summary of the notification and its key requirements: Details of the Product and Its Classification

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Indonesia: Temporary Closure of Medical Devices Licensing and Online Certification Systems

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The Ministry of Health in Indonesia has announced a temporary closure of its medical devices licensing system and online certification platform for maintenance purposes, as outlined in Announcement No. FR.03.01/E.V/2653/2024, dated December 11, 2024. System Closure Details Medical Device Licensing System The medical device online registration system (REGALKES) available at https://regalkes.kemkes.go.id will be temporarily closed

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Philippines: Implementation Guidelines on the New Schedule of Fees and Charges by the Food and Drug Administration

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The Food and Drug Administration (FDA) has announced the implementation of a new schedule of fees and charges under Administrative Order No. 2024-0016. For over two decades, the FDA’s fees were governed by Administrative Order No. 50 s. 2001. The restructuring of fees aims to align charges with the costs of regulating health products, establishments,

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Philippines: FDA Issues Administrative Order No. 2024-0015 on Updated Regulations for Health Product Establishments

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On November 27, 2024, the Philippine Food and Drug Administration (FDA) released Administrative Order No. 2024-0015, introducing updated regulations on the License to Operate (LTO) requirements for health product establishments. This includes rules for initial applications, renewals, and variations, applicable to medical device distributors (importers, exporters, wholesalers), manufacturers (including packers, repackers, refurbishers, and traders), and

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Philippines: FDA Concludes Pilot Implementation of eServices Portal for CMDN Applications in NCR

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The Philippine Food and Drug Administration (FDA) has concluded the pilot implementation of the Certificate of Medical Device Notification (CMDN) application process through the eServices Portal System. This initiative, outlined in FDA Advisory No. 2024-1089, applied exclusively to applicants within the National Capital Region (NCR). The FDA has issued the following updates for stakeholders and

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Thailand: New Fee Structure for Medical Device Monitoring, Auditing, and Surveillance in 2024

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The Thai Food and Drug Administration (FDA) has officially announced the rates for expenses related to monitoring, auditing, and surveillance activities aimed at ensuring compliance with medical device regulations. This new fee structure, effective from November 13 2024, addresses expenses for document evaluation, testing, facility inspections, and related activities to control the manufacturing, importation, and

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Vietnam: Ministry of Health Requests Information on Medical Devices with Expiring Licenses

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On November 19, 2024, the Infrastructure and Medical Device Administration (IMDA) issued Letter No. 519/HHTB-DKKD, requesting enterprises to provide details about class C and class D medical devices with import licenses that were set to expire on December 31, 2024. The IMDA sought this information to synthesize, report, and propose solutions to the Ministry of

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Malaysia: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities

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Malaysia’s Medical Device Authority (MDA) has issued a draft guidance document for the first edition of Control of Obsolete and Discontinued Medical Devices in Healthcare or Related Facilities. This article provides guidelines on managing medical devices that are obsolete or discontinued to ensure uninterrupted healthcare operations. Obsolete Devices The manufacturer must officially declare a device

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Vietnam: New Circular on Mandatory Price Declaration for Selected Medical Devices

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The Ministry of Health (MOH) in Vietnam issued Circular 29/2024/TT-BYT on November 3, 2024, mandating the price declaration of certain medical devices based on their technical and economic characteristics. This circular specifies the requirements for declaring prices, including the product name and specific model, and will take effect on January 1, 2025: Specific model Detailed

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Indonesia: Deactivation of the Electronic Catalogue System Version 5

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On October 30, 2024, the Deputy for Digital Procurement Transformation at Indonesia’s National Public Procurement Agency (LKPP) issued a decision to deactivate the Electronic Catalogue Version 5, aimed at streamlining the e-Catalogue business process. Key Conditions for Deactivation: Key Conditions for Deactivation: Deactivation of Product Showcase Creation for Local/Sectoral e-Catalogue: Effective immediately, the feature to

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Thailand: Draft Announcement on Medical Device Advertising Licenses by the Thai FDA

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The Thai Food and Drug Administration (FDA) has issued a draft announcement detailing the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. This new draft aims to regulate and control medical device advertisements to ensure accurate, ethical, and culturally appropriate messaging. Key Highlights of the Draft Announcement: Revocation of

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Regulatory Affairs Update: Indonesia

Indonesia: Announcement on International Tender Procurement by Ministry of Health

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On October 10, 2024, Indonesia’s Ministry of Health (MoH) announced the opening of an International Tender Procurement for a project named Strengthening Indonesia’s Healthcare Referral Network (SIHREN). The official announcement is available on the e-Catalogue website in both Indonesian and English. You can access it here. Further details about the procurement process are available in

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