top of page
Search


Hong Kong Moves Toward Regulatory Reform: The Road to CMPR
Hong Kong is taking a decisive step toward strengthening its healthcare regulatory landscape with the planned establishment of the Centre for Medical Products Regulation (CMPR). This move signals a significant shift in how drugs and medical devices will be regulated in the city, reinforcing Hong Kong’s ambition to become a leading international hub for medical innovation. Why CMPR Matters Currently, Hong Kong regulates pharmaceuticals and medical devices through different a
ARQon
13 hours ago2 min read


Malaysia Gazettes New Controls for Aesthetic Medical Devices Effective June 2026
Cyberjaya, January 2026 , Malaysia has taken a significant step toward strengthening patient safety in the aesthetic and beauty sector. The Medical Device Authority (MDA) has officially gazetted the Medical Device (Prescribed Medical Devices) Order 2026, which will come into force on 1 June 2026. This new order expands regulatory oversight over specific medical devices commonly used in aesthetic and cosmetic treatments, reinforcing Malaysia’s commitment to safe, ethical, and
ARQon
3 days ago2 min read


Russia Shifts to Risk-Based Medical Device Oversight with New Roszdravnadzor Model
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
ARQon
Jan 73 min read


Ukraine Approves First National HTA Guidelines for Medical Devices
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
ARQon
Jan 52 min read
bottom of page
.png)