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On 4 December 2025 , the Medical Device Authority (MDA) of Malaysia published a draft guidance document titled “ Definitions of Medical Devices” and opened a public comment period from 4 to 18 December 2025. This draft guidance aims to clarify the classification of medical devices, including what constitutes a “device,” as well as definitions for accessories, components and spare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

Vietnam’s Ministry of Health (MOH) issued a new draft Circular in November 2025, proposing significant updates to administrative procedures for medical device regulation. This move reflects Vietnam’s ongoing efforts to enhance regulatory efficiency, improve transparency, and ensure alignment with global standards as the country's healthcare market continues to expand rapidly. This draft Circular consolidates and updates procedures across multiple regulatory areas, signalling

China has taken a major step forward in strengthening its medical device regulatory framework. On 7 November 2025, the National Medical Products Administration (NMPA) officially released the revised Good Manufacturing Practice for Medical Devices (GMP), replacing the decade-old version issued in 2014. The new GMP will come into full effect on 1 November 2026 , giving the industry one year to transition. This revision marks a significant shift toward globalised standards, en

On 22 September 2025 , the Medical Device Authority (MDA) led a key stakeholder engagement session with the Association of Malaysian Medical Industries (AMMI) in Penang , held at the Iconic Marjorie Hotel. The session, attended by 51 industry participants, focused on strategic discussions regarding regulatory sandboxes for high-tech medical devices, particularly AI-enabled medical devices, and the Medical Device Single Audit Program (MDSAP). These focus areas reflect MDA’s

Indonesia continues strengthening its regulatory landscape with the release of the Regulation of the Minister of Health (Permenkes) No. 11/2025 , issued on 12 November 2025. This regulation introduces updated Business and Product Service Standards for risk-based licensing in the health sub-sector, marking an important step in enhancing service quality, safety, and transparency across the country’s health ecosystem. This new framework aligns with Indonesia’s national effort t

Australia’s Therapeutic Goods Administration (TGA) has introduced major regulatory changes aimed at improving patient safety and reinforcing the traceability of medical devices nationwide. These new requirements, taking effect from 21 March 2026, represent a significant shift in how hospitals, manufacturers, and distributors manage device safety and post-market monitoring. Mandatory Reporting of Device-Related Injuries Under the new regulations, all hospitals in Australia

In the ever-evolving world of medical device regulation, staying ahead of the curve is crucial, especially when entering rapidly growing markets like Malaysia. The newly released Second Edition of MDA/GD/0070 from Malaysia’s Medical Device Authority (MDA) brings clarity and structure to the registration process, especially for manufacturers and authorised representatives who opt for conformity assessment by way of the verification route. Here’s what you need to know and how t

In recent years, the field of regenerative medicine has garnered significant attention worldwide for its potential to revolutionise healthcare by repairing or replacing damaged tissues and organs. Taiwan, with its robust healthcare system and flourishing biomedical sector, is taking proactive steps to enhance its regulatory framework in this innovative field. Understanding the Dual-Track Framework Taiwan's dual-track framework is designed to balance both regulatory oversight

31 October 2025 – Cyberjaya, Malaysia The Medical Device Authority (MDA), under the Ministry of Health (MOH), has issued a media statement to reinforce regulatory control and monitoring of influenza test kits currently available in the Malaysian market. The announcement clarifies that all influenza test kits are classified as In Vitro Diagnostic (IVD) Medical Devices intended strictly for use by trained healthcare professionals. This means these test kits are not approved for

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