China continues to play a central role in the global medical technology market. As innovation in medical devices accelerates, the country’s regulatory framework overseen by the National Medical Products Administration (NMPA) has evolved to ensure that products entering the market meet strict safety, quality, and performance standards. For manufacturers seeking access to the Chinese market, understanding the medical device registration process is essential. The regulatory path

Vietnam is preparing a significant regulatory update for the cosmetics sector. The country’s Ministry of Health has released a draft decree aimed at strengthening oversight of cosmetic products and modernising the existing regulatory framework. If adopted, the new decree would replace current regulations governing cosmetic management and introduce clearer responsibilities for manufacturers, importers, and distributors operating in Vietnam’s rapidly growing beauty and personal

Singapore’s Health Sciences Authority (HSA) has released Revision 4 of its Guidance on Software Medical Devices (GL-04), introducing updated regulatory expectations for Software as a Medical Device (SaMD), including artificial intelligence (AI) and machine learning (ML)-enabled technologies. The revised guidance reflects the rapid growth of digital health solutions and aims to ensure that regulatory oversight keeps pace with emerging software-driven medical technologies. Wit

In January 2026, the U.S. Food and Drug Administration (FDA) finalised its updated Real-World Evidence (RWE) Framework, reinforcing the agency’s commitment to integrating real-world data into regulatory decision-making. The framework strengthens how RWE may be used to support approvals, label expansions, post-market surveillance, and lifecycle management for medical devices and medicinal products. As healthcare systems generate increasing volumes of real-world data, regulator

In February 2026, Malaysia’s Medical Device Authority (MDA) and the Thai Food and Drug Administration (Thai FDA) formally launched a pilot Regulatory Reliance Programme for medical devices. This initiative marks a significant step toward deeper regulatory collaboration within ASEAN and reflects a broader global shift toward reliance-based assessment models. What Is the Regulatory Reliance Pilot? The pilot programme enables Malaysia and Thailand to leverage each other’s regula

In early 2026, India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO) , issued a new draft guidance document aimed at simplifying and clarifying the regulatory requirements for importing In-Vitro Diagnostic (IVD) medical devices into the Indian market. The draft guidance, officially titled “ Guidance for Import of In-Vitro Diagnostic Medical Device” (No. CDSCO/IVD/GD/DRAFT/IMP/01/2026), was released for public feedback in January 2026 and invites co

Taiwan continues to reinforce its position in global medical device regulation, as the Taiwan Food and Drug Administration (TFDA) has been re-elected to chair Working Group 3 (Pre-market: Software as a Medical Device – SaMD) under the Global Harmonisation Working Party (GHWP). This re-election is more than symbolic. It reflects sustained international confidence in Taiwan’s regulatory expertise, particularly in one of the most dynamic and technically complex areas of medical

Indonesia’s Central Statistics Agency (BPS) has officially released the Indonesian Standard Industrial Classification (KBLI) 2025, marking a significant update to the business activity classification framework that underpins licensing, compliance, and economic reporting across the country. The new KBLI was promulgated through BPS Regulation No. 7 of 2025 on 18 December 2025, replacing the previous KBLI 2020 and taking effect immediately. KBLI serves as the authoritative cla

In early 2026, Australia’s Therapeutic Goods Administration (TGA) was formally recognised by the World Health Organisation (WHO) as a WHO Listed Authority (WLA) for the regulation of medical products. This designation confirms that Australia’s regulatory system meets the highest global standards for oversight of medicines, vaccines, biologics, and medical devices. More importantly, it signals a continued shift toward regulatory reliance and international harmonisation. What I

Hong Kong is taking another step toward strengthening regulatory oversight of medical devices, this time through procurement controls. Recent developments under the Medical Device Administrative Control System (MDACS) indicate that medical devices must now meet specific registration requirements before being eligible for procurement by public healthcare institutions. While MDACS has historically operated as a voluntary listing system, its practical role in procurement is beco

On 4 January 2026, China’s National Medical Products Administration (NMPA) issued an important regulatory announcement adjusting parts of the Medical Device Classification Catalogue (Announcement No. 132 of 2025). The update introduces targeted changes to the classification and technical descriptions for 31 categories of medical devices, effective immediately. These revisions reflect the NMPA’s continued effort to modernise regulatory oversight by aligning product categori

Vietnam’s Ministry of Health has introduced an important regulatory development for medical devices with the issuance of Circular No. 57/2025/TT-BYT on 31 December 2025. This guidance provides a structured classification framework for medical devices in the context of procurement, clarifying how devices should be grouped based on technical standards and quality requirements. The new rules will take effect on 15 February 2026, with classification requirements applying from