PART 1

Enhanced Regulatory Mutual Recognition: Accelerated Cross-Border Cooperation, Improved Market Access Efficiency

Malaysia and Thailand Launch Regulatory Trust Program, Facilitating ASEAN Market Access

At the 29th GHWP annual meeting, the Malaysian MDA and the Thai FDA signed a confidentiality agreement, officially launching a pilot program for medical device regulatory trust. This cooperation marks a new stage in regulatory integration between the two countries, providing companies targeting the ASEAN market with faster approval speeds and lower compliance costs, helping them seize market opportunities earlier.

Australian and Indonesian Drug Regulatory Agencies Listed by WHO, Expanding Global Mutual Recognition Network

The World Health Organization officially recognized the Australian Therapeutic Goods Administration (TGA) and the Indonesian National Agency of Drug and Food Control (BPOM) as "WHO Listed Regulatory Authorities." The regulatory systems of both countries meet the highest international standards of the WHO in pharmaceutical product regulation. With their inclusion, the global WLA network now covers 41 regulatory agencies in 39 countries, significantly improving its inclusiveness and representativeness. Through the WLA framework, other regulatory agencies, international organizations, and procurement entities can directly accept WLA's review conclusions, effectively reducing redundant reviews, alleviating supply bottlenecks, and strengthening regional supply chain resilience.

PART 2

Stronger Regulation in Specialized Fields: Focusing on High-Risk Scenarios, Building a Solid Safety Barrier

New Malaysian Regulations for Aesthetic Medical Devices Effective in June, Operators Require Qualification Certificates

The "Medical Devices (Specified Medical Devices) Order 2026" issued by the Malaysian MDA will come into full effect on June 1, 2026, bringing high-risk aesthetic medical devices such as laser treatment devices, HIFU ultrasound devices, and liposuction-related devices under strict regulation. The core requirement of the new regulations is that all operators must hold government-recognized qualification certificates, eliminating risks such as unlicensed operation and insufficient skills from the source and ensuring consumer safety.

Australian UDI System Implemented in Stages, High-Risk Implantable Devices Traced First

On December 17, 2025, the Australian TGA officially implemented the Unique Device Identification (UDI) system, enabling full-process traceability of medical devices through globally unified coding. From July 1, 2026, high-risk implantable devices will be included first, followed by a gradual expansion to all categories. UDI information will be simultaneously included in recall notices and patient implant cards. Medical institutions need to integrate UDI into their procurement and treatment record systems, and relevant parties can obtain implementation guidelines through TGA's dedicated channels.

PART.3

Optimized Classification and Regulation: Relaxing Regulations in Low-Risk Areas and Encouraging Industry Innovation

US FDA Relaxes Regulation of Health-Related Wearable Devices, Clarifying the Red Line for "Medical-Grade" Claims

The US FDA has released the latest guidance document, relaxing the regulation of health and lifestyle wearable devices and related software. Low-risk products such as fitness apps and activity trackers, if they only provide general health information and do not involve disease diagnosis and treatment claims, will be classified as non-medical devices and exempted from strict regulation. However, regulators have clearly defined the red line: companies are not allowed to make "medical-grade" claims (such as measuring blood pressure and other medical indicators) to prevent users from adjusting their medication without authorization. This move strikes a balance between encouraging innovation and protecting public health, providing more product iteration space for the relevant industries.

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