The Singapore Health Sciences Authority (HSA) has released Revision 15 of GN-15: Guidance on Medical Device Product Registration, introducing a new Premarket Submission Checklist as a mandatory component of selected medical device registration applications. The update strengthens HSA’s focus on dossier completeness and submission readiness before applications proceed to technical
The Philippine Food and Drug Administration (FDA) has released a draft circular proposing the adoption of Philippine National Standard (PNS) ISO 13485:2019 as the official Good Manufacturing Practices (GMP) guideline for medical device and in-vitro diagnostic (IVD) manufacturing establishments in the Philippines. The proposed requirements would apply to manufacturers, packers,
The Medical Device Authority (MDA) of Malaysia is planning to introduce a hologram-based product authentication measure for selected medical device categories. Based on the latest information shared following discussions between the Malaysia Medical Device Association (MMDA) and MDA, several aspects of the proposed implementation are still being developed and remain
The Halal Product Assurance Organizing Agency (BPJPH) has prepared draft guidelines on the implementation of the Halal Product Assurance System for medical devices and household health products. The draft provides proposed criteria for determining which medical devices would be subject to halal certification, together with requirements relating to materials, halal
The Ministry of Health of the Republic of Indonesia has issued Decree No. HK.01.07/MENKES/951/2026, introducing technical guidelines for the product licensing of software-based medical devices distributed within Indonesia. The guideline sets out requirements and procedures for obtaining a Medical Device Product License for software-based medical devices, with the aim of
On 30 June 2026, the Ministry of Science and Technology issued Circular 36/2026/TT-BKHCN, specifying the list of products and goods with medium and high risks under the management of the Ministry of Science and Technology (MOST), together with their corresponding HS codes aligned with Vietnam’s List of Exported and Imported
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