Qualtech will be exhibiting at BIO Asia–Taiwan 2026, taking place from 16–19 July 2026 at the Taipei Nangang Exhibition Center, Taiwan. Visit us at Booth N1007 to connect with our regulatory and business development specialists and discuss medical device registration, regulatory compliance and market access opportunities across Asia Pacific.
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Effective May 15, 2026, Decree No. 90/2026/ND-CP replaces Decree No. 117/2020/ND-CP, strengthening administrative sanctions and compliance control in Vietnam’s medical device sector. Non-compliance may result in higher fines, product circulation restrictions and temporary business suspension, which may affect supply chains and hospital tenders. To maintain smooth operations, companies are recommended to review classifications, verify localized labeling and align workflows with applicable regulatory timelines.
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The FDA's Electronic Medical Device Reporting (eMDR) program requires medical device manufacturers and importers to submit Medical Device Reports (MDRs) electronically for adverse events, malfunctions, and other reportable incidents. The eMDR system improves the efficiency, accuracy, and timeliness of post-market surveillance by enabling electronic submission, processing, and tracking of reports through FDA systems. Manufacturers should establish robust procedures to ensure compliance with eMDR requirements and maintain effective post-market monitoring of device safety and performance.
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Recent Philippine Food and Drug Administration (PFDA) enforcement actions involving unregistered injectable products highlight the importance of regulatory compliance in the Philippines. This article shares Qualtech's insights on the critical need for strict compliance when expanding into overseas markets, particularly for manufacturers of dermal fillers and other aesthetic injectable products.
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Join Qualtech's free webinar on June 18, 2026, to explore the latest regulatory developments and market access considerations for Australia and New Zealand. This session will provide practical insights into Australia TGA application pathways, key TGA updates in 2026, and the current regulatory framework in New Zealand, helping medical device manufacturers better prepare their ANZ market entry strategies.
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On 20 April 2026, Singapore's Health Sciences Authority (HSA) and Japan's Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation (MOC) in Tokyo to enhance bilateral regulatory collaboration. The press release (issued on 21 April 2026) notes that the MOC aims to promote reliance for health products, establish mutual reliance for Good Manufacturing Practice (GMP) inspections, and support information exchange on emerging technologies.
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The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.
More Effective May 6, 2026, Administrative Order No. 2025-0030 establishes a mandatory Post-Marketing Alert System (PMAS) for medical devices in the Philippines, aligning national policy with the ASEAN Medical Device Directive. The order requires manufacturers, traders, and distributors to maintain strict traceability records, report adverse events within 48 hours to 30 days, and implement Field Safety Corrective Actions to mitigate risks. A one-year transition period for industry compliance has officially commenced.
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As EU MDR expectations continue to intensify in 2026, manufacturers are facing greater scrutiny across technical documentation, clinical evidence, and lifecycle compliance. Qualtech's webinar recap highlights practical insights on MDR transition planning, Annex XVI obligations, notified body expectations, and key compliance priorities shaping EU market access strategies.
More The Medical Device Authority (MDA) has published the latest edition of the guidance document Definition of Medical Device which provides additional clarification on the definition and regulatory interpretation of medical devices, including accessories, components, and spare parts. The document is intended to assist industry stakeholders in the proper identification of device classifications and ensuring compliance with the Medical Device Act 2012 (Act 737).
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