Indonesia Perpres 6/2023 requires Halal certification for drugs, biological products, and medical devices containing animal-derived materials. BPJPH issues the certificates, while foreign Halal certificates from bodies with an MRA are accepted after registration. Phased compliance is based on risk class: Class A by 2026, B by 2029, C by 2034, and D/biological products by 2039. Non-animal-based devices are exempt unless containing prohibited ingredients, which must be clearly labeled as non-Halal.

Australia’s TGA 2026 guidance clarifies AI medical software regulation, specifying when AI qualifies as a medical device. Manufacturers must assess intended use, risk class, and compliance with international standards like IEC 62304 and ISO 14971. Post-market monitoring, usability, and cybersecurity requirements ensure safe and effective deployment. Following TGA guidance helps developers streamline ARTG submissions and maintain compliance across the software lifecycle.

Commission Implementing Decision (EU) 2026/193 updates EU harmonised standards supporting the Medical Device Regulation (EU) 2017/745. Revised ISO standards now cover neurosurgical implants, biological and clinical evaluation, sterilisation, non-active surgical implants, breathing gas pathways, and small-bore connectors. Manufacturers should assess gaps, update technical documentation, and align conformity strategies to maintain MDR compliance.

Swissmedic published the results of its 2025 market surveillance focus campaign on medical device importers on 30 January 2026. Inspections of 30 importers and 232 devices identified deficiencies in 22% of devices, with higher non-compliance among legacy MDD devices than MDR devices. Key issues included importer labelling, product verification, and storage and transport conditions, highlighting the continued need for compliance improvements.

The UK MHRA updated its medical device registration guidance on 16 January 2026, introducing new annual registration fees effective from 1 April 2026. Fees will be charged at approximately £300 per year per Level 2 GMDN® Category, replacing the current one-off fee model. Manufacturers must review GMDN® classifications, budget for recurring fees, and ensure all registrations and payments are managed through DORS.

The US FDA updated Compliance Program CP 7382.850 on 2 February 2026, expanding inspections to a Total Product Life Cycle (TPLC) approach. The program aligns with QMSR (21 CFR 820) incorporating ISO 13485:2016 and emphasizes UDI, labeling, tracking, reporting, and postmarket surveillance. Manufacturers and importers must review quality systems, registration, and TPLC compliance to meet inspection and enforcement expectations.

Malaysia’s Medical Device (Designated Medical Device) Order 2026 designates certain aesthetic devices—such as medical lasers, HIFU, and liposuction systems—as medical devices under Act 737. Effective 1 June 2026, these devices must comply with MDA registration and intended-use requirements. The Order clarifies regulatory obligations for manufacturers, importers, and clinics, reinforcing patient safety and regulatory oversight in Malaysia’s aesthetic medical sector.

Singapore HSA’s GL-04 Revision 4 updates regulatory guidance for Software as a Medical Device (SaMD) and Machine Learning-enabled Medical Devices (MLMD). Key changes include expanded scope for ML functions, lifecycle governance, enhanced cybersecurity requirements, structured change management via CMP, and alignment with IMDRF/ISO standards. Manufacturers must strengthen lifecycle oversight, post-market monitoring, and ML model documentation to comply with the updated framework.

ANVISA’s 2025 manual clarifies how medical devices and Software as a Medical Device (SaMD) must be regularized in Brazil. It explains regulatory pathways, risk classification, documentation requirements, and registration or notification steps. By aligning with Brazil’s current regulatory framework, the guidance improves transparency and consistency for manufacturers, importers, and legal representatives seeking ANVISA market authorization.