• 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.

• 2025-11-26 06:54:12

On 2 October 2025, the Singapore Health Sciences Authority (HSA) conducted the Health Products Regulatory Conference 2025, which was held jointly with the Singapore Manufacturing Federation (SMF) MedTech Day. The event elevated the theme: "Advancing Singapore's Medtech Ecosystem: be connected, collaborative, and future-ready".
During the conference, the HSA's Medical Device Cluster (MDC) shared insights on the evolving regulatory landscape, examining both present developments and anticipated future trends in the field, especially related to digital health products.

• 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 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.

• 2025-04-11 02:14:00

Join Qualtech Consulting Corporation on April 24th for an insightful webinar, "Navigating India’s Medical Device Regulatory Landscape: A Comprehensive Guide." This session is tailored for both newcomers and seasoned professionals seeking to demystify India's evolving medical device approval process

• 2024-12-16 08:47:55

This guidance clarifies the regulatory framework for the use of EtO in sterilizing medical devices and in vitro diagnostic medical devices.

• 2024-10-08 05:56:39

Join Qualtech's Webinar on India's Medical Device Market and Regulations