Regulatory updates Archives

Malaysia: MDA Announces Transition to Online Product Classification Application & Implementation of Validity Period for Product Classification Letter

April 21, 2025

On April 8, 2025, the Medical Device Authority (MDA) of Malaysia released two important regulatory updates to enhance efficiency, strengthen compliance, and improve the overall submission process for product classification. These updates are effective starting May 1, 2025. The first update mandates the full transition to online submission for product

Thailand: (Draft) Criteria, Methods, and Conditions on Labeling and Documentation (IFU) for Medical Devices

April 18, 2025

On March 18, 2025, the Ministry of Public Health (MoPH) of Thailand released a draft notification to amend its 2020 regulation on the criteria, methods, and conditions for labeling and documentation of medical devices (B.E. 2563), in alignment with the Medical Device Act B.E. 2551 (2008) and its 2019 amendment.

Indonesia: Update in the Listing of Healthcare Facilities in the Ministry of Health’s Sectoral Showcase

April 11, 2025

On March 21, 2025, the Ministry of Health announced an update regarding the listing of healthcare facilities in the Sectoral Showcase of the Electronic Catalogue Version 5. This follows the issuance of Circular Letter Number 6432/KA/03/2025, which outlines the transition process for medical device commodities in the procurement system. According

Indonesia: Follow-Up Notification on the Electronic Catalogue Transition to Version 6

April 11, 2025

On March 20, 2025, the Indonesian government issued a follow-up notification in accordance with Circular Letter No. 9 of 2024 regarding the transition from Electronic Catalogue Version 5 to Version 6. The updated guidance outlines the deactivation of certain commodities from Version 5 and introduces a phased migration to the

Philippines: Draft for Comments || Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration

April 7, 2025

On March 31, 2025, the Food and Drug Administration (FDA) of the Philippines released a draft circular titled “Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration”. The draft circular aims to establish effective recall procedures for authorized health products regulated by the FDA

Philippines: FDA Advisory No. 2025-0368 on Operating Periods of FDA ePortal

March 28, 2025

Register your medical device in the Philippines On March 21, 2025, the Food and Drug Administration (FDA) of the Philippines issued FDA Advisory No. 2025-0368, notifying stakeholders of updates to the operating periods of the FDA ePortal system. This change is part of ongoing system maintenance and upgrades aimed at

Regulatory Updates

Regulatory Updates

Malaysia: MDA Announces Transition to Online Product Classification Application & Implementation of Validity Period for Product Classification Letter

Thailand: (Draft) Criteria, Methods, and Conditions on Labeling and Documentation (IFU) for Medical Devices

Indonesia: Update in the Listing of Healthcare Facilities in the Ministry of Health’s Sectoral Showcase

Indonesia: Follow-Up Notification on the Electronic Catalogue Transition to Version 6

Philippines: Draft for Comments || Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration

Philippines: FDA Advisory No. 2025-0368 on Operating Periods of FDA ePortal

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Main Pages

Address

E-mail Address

Phone Number

Regulatory Updates

Regulatory Updates

Malaysia: MDA Announces Transition to Online Product Classification Application & Implementation of Validity Period for Product Classification Letter

Thailand: (Draft) Criteria, Methods, and Conditions on Labeling and Documentation (IFU) for Medical Devices

Indonesia: Update in the Listing of Healthcare Facilities in the Ministry of Health’s Sectoral Showcase

Indonesia: Follow-Up Notification on the Electronic Catalogue Transition to Version 6

Philippines: Draft for Comments || Guidelines on the Recall of Authorized Health Products Regulated by the Food and Drug Administration

Philippines: FDA Advisory No. 2025-0368 on Operating Periods of FDA ePortal

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Main Pages

Address

E-mail Address

Phone Number

Don’t miss a single regulatory shift in Southeast Asia!