Regulatory updates Archives - Page 13 of 16

Philippines: FDA Advisory No. 2025-0095-A || Lifting of the Advisory on the Interim Extension of Renewal Application Period of LTO Prior to Expiration of Validity Under FDA Advisory No. 2025-0095

July 8, 2025

The Food and Drug Administration (FDA) informs its stakeholders that effective immediately, all applications for renewal of License to Operate (LTO) shall revert to the prescribed renewal period of ninety (90) calendar days prior to its expiration, following Administrative Order 2024-0015, titled “Prescribing the Rules, Requirements and Procedures in the Application

Philippines: FDA Advisory No. 2025-0729 || Guidelines on the Re-issuance of Order of Payment

July 8, 2025

The Food and Drug Administration (FDA) has issued an advisory regarding the Guidelines on the Re-issuance of Order of Payment following the temporary suspension of AO No. 2024-0016. Applications filed during the effectivity of the said AO but not yet paid may request a reissued Order of Payment reflecting the previous (lower) fees.

Indonesia: MoH Extends Product Listing Period for e-Catalogue Version 5

July 3, 2025

The Ministry of Health (MoH) of Indonesia has officially extended the product listing period in the Sectoral Healthcare Facility Showcase on e-Catalogue Version 5. This update follows the recent socialization session conducted on June 25, 2025. Read the Announcement (Indonesian): Updated Schedule – e-Catalogue V5 Listing Extension Please note: The

Vietnam: MOH Announces Preparatory Steps for 2025 Medical Device Dialogue Conference

June 30, 2025

The Vietnam Ministry of Health (MOH) has released Notification No. 3776/BYT-HTTB, announcing the upcoming 2025 Dialogue Conference between the MOH and medical device businesses. The event is scheduled to take place in early August 2025 in Nha Trang City, Khanh Hoa Province. This annual dialogue offers stakeholders an important platform

Malaysia: New Login Feature via MyDigital ID

June 25, 2025

The Medical Device Authority (MDA) informed all users that, starting 23 June 2025, a new login feature via MyDigital ID will be supported in MedC@St 2.0+. This enhancement aims to strengthen account security, protect user access, and reduce the risk of identity fraud. To log in or view the system,

Malaysia: MDA Releases Third Edition of ASEAN Harmonised Medical Device Classification Guidance (MDA/GD/0062)

June 20, 2025

The Medical Device Authority (MDA) has issued the Third Edition of the Guidance Document MDA/GD/0062: Harmonised Classification of Medical Devices in ASEAN. This document supersedes previous editions and provides an updated list of harmonised risk classifications for general and in-vitro diagnostic (IVD) medical devices, as agreed by the ASEAN Medical

Regulatory Updates

Philippines: FDA Advisory No. 2025-0095-A || Lifting of the Advisory on the Interim Extension of Renewal Application Period of LTO Prior to Expiration of Validity Under FDA Advisory No. 2025-0095

Philippines: FDA Advisory No. 2025-0729 || Guidelines on the Re-issuance of Order of Payment

Indonesia: MoH Extends Product Listing Period for e-Catalogue Version 5

Vietnam: MOH Announces Preparatory Steps for 2025 Medical Device Dialogue Conference

Malaysia: New Login Feature via MyDigital ID

Malaysia: MDA Releases Third Edition of ASEAN Harmonised Medical Device Classification Guidance (MDA/GD/0062)

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