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 […]
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
Malaysia: Transition to Online Advertising Application Process in Malaysia Read More »
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
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
Thailand: Medical Device Control Division Implements Improved Change Notification System Read More »
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
On January 22, 2025, the Medical Device Authority (MDA) of Malaysia released a draft guidance document for the second edition of Importation of Medical Device for Personal Use (MDA/GD/0066).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
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
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
Thailand: Thai FDA Issues Guidelines for Medical Device Sellers Read More »
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
Vietnam: Enterprises Declaring Medical Device Prices at the Ministry of Health Read More »
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
Vietnam: Extension on Medical Device Import Licenses Read More »
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
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
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
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,” which became effective on 4th December 2024. Key Highlights of GN-37-R1 Introduction of the Change Management Program (CMP) The CMP provides a framework for “pre-specified changes” that SaMD manufacturers can implement
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
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
Indonesia: Update on Listing Product Schedule in the Ministry of Health e-Catalogue Read More »
As Cambodia’s regulatory landscape evolves, our Cambodia team provides strategic insights and proactive guidance for market entry and compliance. Fluent in Khmer, with a deep understanding of the local market, they help ensure your business thrives in this emerging region.
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.
Our Philippines team specialises in navigating local regulatory frameworks, providing expertise in product licensing, adverse event reporting, and post-market surveillance. Fluent in Filipino and English, their local presence and industry expertise ensure compliance at every stage.
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.
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.
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.
Melody oversees logistics, ensuring efficient execution of services from market entry to compliance. With a strong grasp of local customs and regulations, she ensures timely deliveries and strict regulatory adherence.
Leading our business development and client relationship efforts, ShouZheng brings extensive experience in medical device market trends across Southeast Asia. Their insights enable teams to stay focused on client needs and regional market demands.
As CEO, Mourad steers the company’s strategic direction, fostering a unified approach across all regions. With [XX] years of industry experience, Mourad provides strong leadership, ensuring each team is equipped to meet client needs effectively.
May spearheads our global marketing strategy, ensuring each region’s distinct value proposition is communicated clearly. Her expertise ensures a cohesive brand presence while customising messages to resonate with local markets.
Paul oversees operational efficiency across all regions, ensuring teams perform at their highest potential. With expertise in operational management, he ensures seamless execution of every project, from product registration to market launch.
As CEO, Mourad steers the company’s strategic direction, fostering a unified approach across all regions. With years of industry experience, Mourad provides strong leadership, ensuring each team is equipped to meet client needs effectively
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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