On January 22, 2025, the Medical Device Authority (MDA) of Malaysia released a draft guidance document for the second edition of Importation of Medical Device for Personal Use (MDA/GD/0066).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
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
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
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 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
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 As of January 1, 2025, Test Result Reports issued by these Foreign Test Centres are no longer valid for the Certification
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