• 2026-04-23 09:11:50

Singapore's Health Sciences Authority (HSA) has achieved the World Health Organization (WHO) Maturity Level 4 for medical device regulatory systems, the highest classification under WHO's global benchmarking framework. The recognition, announced on 10 March 2026 during the International Medical Device Regulators Forum (IMDRF) 29th session in Singapore, strengthens Singapore's position in global medical device regulation as a trusted reference authority for other regulators.

• 2026-04-23 07:36:58

The webinar hosted by Qualtech in March takes a closer look at how medical device studies are conducted in the United States. Covering US FDA classification, IDE and IRB pathways, and study design, it connects regulatory frameworks with their practical application in study execution. This recap highlights key considerations shaping how studies are structured and managed in the US context.

• 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

• 2026-02-25 04:14:57

The Ministry of Food and Drug Safety (MFDS) has amended the Regulation on Permission, Notification, Review, Etc. of Medical Devices, effective 26 January 2026. The revision expands acceptable clinical documentation, integrates Class II certification responsibilities, refines the regulatory framework for innovative medical devices, clarifies technical documentation requirements, and strengthens cybersecurity submission obligations for connected devices. These updates aim to enhance regulatory clarity, align with international standards, and improve the efficiency of approval and certification procedures in South Korea.

• 2026-01-30 03:45:43

The NMPA issued revised regulation on the administration of export sales certificates of medical devices, effective May 1, 2026.

• 2025-09-24 08:22:59

The Medica Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore officially launched a 6-month pilot of the Medical Device Regulatory Reliance Programme to streamline approvals for Class B–D devices. The main purpose are to fast-track market access, cutting cost, reducing duplication and enhanced patient care.

• 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

• 2025-08-25 03:35:27

The Ministry of Health Malaysia (MOH) has announced an international regulatory collaboration with China National Medical Products Administration (NMPA). This collaboration aims for accelerate pre-market approvals, quicker market access, reduced costs and enhanced patient care while strengthens Malaysia's role as regional regulatory hub.

• 2025-07-10 09:14:07

The Health Science Agency (HSA) are pleased to announce the launch of SHARE (Singapore Health Product Access and Regulatory E-System). This new system will replace the existing MEDICS system for medical device product registrations and license submissions.
SHARE was first time introduced to the stakeholders during an Industry Briefing on May 21, 2025. During the session, HSA highlighted key changes implemented for medical devices on SHARE, demonstrated the user interface and key features, and outlined the timeline for the full transition from MEDICS to SHARE, effective July 14, 2025.

• 2025-06-03 07:01:37

On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India’s regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.