During Medical Taiwan 2025, Qualtech engaged with manufacturers and distributors seeking trusted support for regulatory navigation and market expansion across the APAC region. With growing opportunities throughout this dynamic market, Qualtech continues to serve as a trusted partner for global medical device manufacturers expanding across Asia.
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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.
Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.
More 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.
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On April 28, the National Medical Products Administration (NMPA) issued the Guidelines for Quality Management of Online Sales of Medical Devices, which will come into effect on October 1, 2025.
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Join Qualtech at Medical Taiwan 2025. Connect with regulatory experts for guidance on medical device registration, local representation, and compliance in the Asia-Pacific markets.
More Stay ahead in China's evolving medical device regulations! Join our FREE webinar to master NMPA registration, technical reviews, and post-market compliance. Gain expert strategies to accelerate approvals and avoid risks—whether entering the market or optimizing compliance. Secure your spot now!
More On March 26, 2025, Qualtech hosted a regulatory webinar exploring the process of medical device approval in Australia. The session covered essential topics including device classification, conformity assessment options, ARTG registration steps, sponsor and manufacturer obligations, post-market surveillance, and upcoming UDI requirements. Practical tips and FAQs helped attendees better prepare for TGA submissions and long-term compliance in the Australian market.
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The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.
More Australia’s implementation of the Unique Device Identification (UDI) system marks a major advancement in medical device traceability and regulatory oversight. This article provides medical device manufacturers with essential guidance on the TGA’s UDI requirements, timelines, and compliance obligations from 2025 through 2030. It also outlines key roles, exemptions, and actionable strategies to support successful market access and patient safety.
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