Malaysia’s Medical Device Authority (MDA) and China’s NMPA have launched the Pilot Phase I of their 2025 Regulatory Reliance Programme, enabling expedited market access for in-vitro diagnostic (IVD) devices. Running from 30 July to 30 September 2025, this bilateral initiative allows qualified manufacturers in both countries to streamline approvals under mutual recognition.

Brazil’s new RDC 982/2025 introduces a risk-based approach to Good Manufacturing and Distribution Practices, tying certification to product risk, compliance history, and recognized international audits. This shift streamlines ANVISA approvals, shortens timelines, and reduces redundant inspections for qualified companies.

Brazil’s Siscomex system is introducing new Product Catalog requirements under Import Announcement No. 070/2025, with updates that directly affect how medical device import data must be described, classified, and aligned with ANVISA records. Starting in 2026, inconsistent or incomplete catalog entries could lead to customs delays, regulatory scrutiny, or even penalties.

The Philippines FDA has temporarily suspended its steep 2025 medical device registration fee hike, reverting to much lower legacy rates for 60 days starting June 10. This brief window offers manufacturers a chance to register at prices more than 10 times cheaper, making it a critical opportunity for cost savings and market entry.

Malaysia and China have signed a landmark mutual recognition agreement to fast-track medical device approvals between the two countries, effective 30 July 2025. The 2025 Regulatory Reliance Programme enables Malaysian IVDs to access China’s Green Channel and allows Chinese devices to enter Malaysia via an accelerated 30-day review.

Singapore’s HSA has updated its 2025 guidelines on SaMD and CDSS, aligning terminology with global standards and clarifying key classification rules. The revision helps developers determine if their software qualifies as a regulated medical device and what risk class applies, especially for AI-based or mobile platforms.

The EU has released new guidance clarifying how the Artificial Intelligence Act (AIA) applies to AI-enabled medical devices already regulated under MDR and IVDR. MDCG 2025-6 outlines what qualifies as high-risk Medical Device AI (MDAI) and how manufacturers can integrate AIA requirements—such as bias mitigation, transparency, and cybersecurity—into existing quality systems.

Mexico’s updated Acuerdo Dispositivos Médicos Julio 2025 introduces major changes to the classification, registration, and exemption rules for low-risk medical devices. With new annexes, timelines, and GMP requirements now in effect, manufacturers must reassess their regulatory strategy to maintain market access.

Singapore’s revised GN-21 guidance streamlines medical device change notification by expanding exemptions, clarifying pathways for machine learning-enabled devices, and introducing new UDI data requirements. These updates reduce regulatory burden while reinforcing oversight of post-market changes.