Malaysia MDA, Issuance of the 2nd edition of the guideline for the placement of HIV-Self Test (HIVST) Kit in Malaysia Market

On January 31, 2025, the Medical Device Authority (MDA) of Malaysia issued the 2nd edition of the guidelines (MDA/GD/0065) to guide companies on the requirements for pre-market, placement in the market and post-market activities for HIV self-testing kits (HIVST) in the Malaysian market.  The key updated contents of the guidelines are as follows: 1) Regulatory requirements for facilities handling..

On February 7, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea announced the partial revision of the Enforcement Rules of the Cosmetics Act (Presidential Decree No.2012) following the amendment of the Cosmetics Act (Law No. 20248, promulgated on February 6, 2024, and effective from February 7, 2025).  The main revisions, which include improvements and supplements to address some..

On January 24, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea established the guideline for the approval and review of standalone digital medical device software utilizing usability in accordance with the implementation of the Digital Medical Products Act.  The guideline was created to clearly explain the scope and criteria for usability evaluation when approving or reviewing standal..

On January 6, 2025, the Central Drugs Standard Control Organistion (CDSCO) of India released a draft updating on existing risk-based medical device classification list. This update includes reclassification and new classifications for the following categories:1. Interventional Radiology2. Radiotherapy3. Oncology4. Class A (Non-Sterile and Non-measuring) medical devices The updated guideline in I..

According to the amendment of Regulation EC No. 1223/2009, revised on April 3, 2024, the use of Vitamin A, Alpha-Arbutin, Arbutin, and certain substances with potential endocrine-disrupting properties in cosmetics will be restricted in the European market starting from February 2025. The key amendments are as follows: * Addition to Annex III (Restricted Substances): Among the eight substances, G..

On December 17, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a partial revision of the medical device standard specifications. The revision was made to align with international standards, aiming to enhance the safety and quality levels of medical devices distributed domestically and to prevent potential health risks to the public.  The revisions made to align the medic..

On January 2, 2025, the Indonesia BPOM (Badan Pengawas Obat dan Makanan) launched the cosmetic notification system, Notifkos 3.0.  1. The main features of the system are as follows: 1Cosmetic Distribution Permit- New products- Export-only products- Product clustering2Cosmetic Notification Updates- Product updates- Cosmetic kit updates- Updates for export products3Company Changes/Change Notificat..

December 13, 2024, The Therapeutic Goods Administration (TGA) of Australia has announced the publication of the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.3) 2024, which reflects transitional measures for IVD products. This determination allows manufacturers to register IVD products in Australia to meet product regist..