China’s National Medical Products Administration (NMPA) released two draft announcements for public consultation on September 25, 2025 , outlining plans to expand the Unique Device Identification (UDI) system to nearly all classes of medical devices. This proposed expansion marks a significant step in China’s ongoing effort to enhance post-market surveillance, traceability, and regulatory transparency within the medical device sector. Strengthening Device Traceability and Pa

In a move to further strengthen Singapore’s position as a regional hub for medical technology innovation, the Health Sciences Authority (HSA) and the Singapore Manufacturing Federation – Medical Technology Industry Group (SMF MTIG) have launched a new collaborative initiative aimed at supporting medical technology (MedTech) companies with early regulatory guidance and market access readiness. Announced on 2 October 2025 , this partnership builds on Singapore’s broader strat

The Medical Device Authority (MDA) of Malaysia has released the first edition draft guidance document titled “𝘈𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘊𝘰𝘯𝘧𝘪𝘳𝘮𝘢𝘵𝘪𝘰𝘯 𝘚𝘵𝘢𝘵𝘶𝘴 𝘰𝘧 𝘖𝘳𝘱𝘩𝘢𝘯𝘦𝘥 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦”. It is inviting industry stakeholders to provide feedback. This document is a significant step toward managing legacy medical devices that remain in healthcare facilities without active manufacturer or Authorised Representative (AR) oversight, ensur

The Philippine medical device market has opened a crucial window of opportunity for manufacturers preparing their market entry or renewals. On September 5, 2025 , the Philippines Food and Drug Administration (FDA) issued Department Circular No. 2025-0382, announcing the extension of the temporary suspension on medical device registration fees. This follows the initial suspension granted earlier in the year and underscores the agency’s continued commitment to balancing regu

India’s medical device sector is undergoing a significant transformation as the government intensifies efforts to harmonize local...

Indonesia has unveiled an ambitious, multi-decade roadmap to transform its domestic medical device landscape, aiming for full...

In a powerful display of commitment to global harmonization and regulatory efficiency, Malaysia’s Medical Device Authority (MDA) has...

On 5 September 2025, the National Medical Products Administration (NMPA) announced an update to the Medical Device Classification...

On 1 September 2025 , Singapore’s Health Sciences Authority (HSA) and Malaysia’s Medical Device Authority (MDA) launched a six-month...

On 17 September 2025 , the National Pharmaceutical Regulatory Agency (NPRA) released a safety signal alert concerning the anticonvulsant...

On 3 July 2025, the Philippines Food and Drug Administration (FDA) issued Circular No. 2025-003, officially adopting the Codex Guidelines...

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a Route B notification pilot, a key step in...

The Thai Food and Drug Administration (FDA) recently announced new regulations to streamline the process of renewing licenses for medical...

The National Public Procurement Agency of Indonesia (LKPP) officially announced the deactivation of Version 5 of the E-Catalogue for...

22 August 2025 marked a milestone moment for the medical device industry in Southeast Asia, as the Medical Device Authority (MDA) and the...

As part of its ongoing efforts to streamline regulatory processes and ensure better clarity for applicants, the Health Sciences Authority...

On 28 July 2025, the National Medical Products Administration (NMPA) officially issued two new information standards that will come into...

Since 1 November 2023, Hong Kong has embraced the “1+ mechanism” , a progressive pathway for registering new drugs. Under this system,...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been officially designated as a WHO-Listed Authority (WLA)  by...

In a landmark move for international medical device regulation, the Medical Device Authority (MDA) and National Medical Products...