January 2025

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

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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

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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

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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 As of January 1, 2025, Test Result Reports issued by these Foreign Test Centres are no longer valid for the Certification Process unless the centres are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

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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

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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

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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)

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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

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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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Indonesia: Dermal Filler Classified as a Medical Device

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On December 19, 2024, the Indonesian Ministry of Health issued Letter No. FR.03.01/E.V/2728/2024, officially classifying dermal fillers as medical devices. This announcement provides guidance to facilitate the importation of dermal fillers into Indonesia while ensuring compliance with regulatory requirements: Classification of Dermal Fillers Dermal fillers are categorized as medical devices under the General Surgical Equipment

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Welcome to Andaman Medical. We are your trusted partner for regulatory affairs and market access in Southeast Asia. 

Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.
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ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
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ANDAMAN MEDICAL PTE LTD
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653

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