On 28 November 2025 , Russia implemented significant changes to its medical device regulatory oversight system managed by the Federal Service for Surveillance in Healthcare (Roszdravnadzor). Roszdravnadzor updated its approach to compliance inspection and market surveillance by introducing a risk-based model with preventive visits and formal remote supervision requirements. This regulatory shift marks a departure from routine scheduled inspections in favour of a more targete

In a major regulatory development, Ukraine’s Ministry of Health officially approved the Guidelines on Health Technology Assessment (HTA) for Medical Devices (Order No. 1771) on 21 November 2025 . This marks the first time Ukraine has adopted a dedicated methodological framework for HTA of medical devices, enabling practical implementation of policy mandates that were previously difficult to operationalise. Health Technology Assessment is an evidence-based evaluation process

Kazakhstan has introduced significant regulatory changes to its medical device and pharmaceutical registration framework as the country continues to align with wider Eurasian Economic Union (EAEU) requirements. These developments impact manufacturers, authorised representatives, and importers seeking market access in Kazakhstan and across the EAEU. Amendments to Registration Procedures (Nov 2025) On 18 November 2025 , Kazakhstan’s Ministry of Health issued amendments to the r

On 1 December 2025 , the Medical Device Authority (MDA) of Malaysia announced an update to the enforcement timeline for the country’s Medical Device Import Permit requirement. The enforcement, originally scheduled to take effect on January 2, 2026, has now been postponed to July 1, 2027. This extension gives industry stakeholders additional time to prepare for full compliance with the new import control framework under the Customs (Prohibition of Import) Order 2023. The

On 12 December 2025, the United Kingdom and Singapore announced a landmark regulatory collaboration aimed at accelerating patient access to breakthrough health technologies. The initiative, known as the Regulatory Innovation Corridor, brings together the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore’s Health Sciences Authority (HSA) in a first-of-its-kind coordinated fast-track pathway. This new framework allows developers of high-impact healt

South Korea has taken another major step toward shaping the future of digital health regulation. In late November 2025, the Ministry of Food and Drug Safety (MFDS) released an updated guidance document providing clearer, more structured expectations for the development, approval, and lifecycle management of AI-enabled and software-based medical devices. As artificial intelligence continues to transform diagnostics, treatment planning, and patient monitoring, regulatory autho

South Africa has taken a significant step forward in strengthening its medical device regulatory framework. On 9 September 2025 , the South African Health Products Regulatory Authority (SAHPRA) published the Guidelines on Clinical Evaluation of Medical Devices (SAHPGL-MD-16_v1). This long-anticipated update brings more clarity, structure, and global alignment to how manufacturers must demonstrate clinical evidence. This updated guideline is designed to modernise South Africa’

Malaysia has achieved a significant milestone in global medical device regulation. The Medical Device Authority (MDA), a ministry of the Ministry of Health Malaysia, has announced that its Chief Executive Officer, Dr Muralitharan Paramasua , has been elected as the Chair of the Global Harmonisation Working Party (GHWP) for the 2026–2028 term. The appointment was confirmed during the 29th GHWP Annual Meeting, held from December 1 to 4, 2025, in Bangkok, Thailand . Dr Muralit

On 4 December 2025 , the Medical Device Authority (MDA) of Malaysia published a draft guidance document titled “ Definitions of Medical Devices” and opened a public comment period from 4 to 18 December 2025. This draft guidance aims to clarify the classification of medical devices, including what constitutes a “device,” as well as definitions for accessories, components and spare parts areas that have often caused uncertainty in regulatory submissions. This is a significant