• 2026-07-28 02:39:21

Starting July 2026, the Australian Therapeutic Goods Administration (TGA) will implement an overall increase in regulatory fees and annual charges for medical devices and in vitro diagnostic (IVD) devices. This article provides a detailed 2025 versus 2026 fee comparison, highlighting an upward adjustment of approximately 4.7% to 6.3% across various submission and maintenance categories. It also includes strategic insights from Qualtech on leveraging overseas approvals and managing hidden compliance costs to optimize long-term operational budgets and market access strategies

• 2026-07-27 03:42:33

The Philippine FDA has issued a draft Circular proposing a comprehensive risk-based framework for post-approval variations of medical and health-related devices. Key proposed changes include the introduction of risk-based variation classifications, a dedicated variation pathway for medical device software (MDSW), single variation applications for eligible multiple product authorizations, updated submission procedures, and enhanced post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers. The draft also provides guidance on timelines, fees, and regulatory enforcement to support a more standardized variation process.

• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 2026-06-26 06:37:19

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.

• 2026-06-26 06:18:15

On 4 June 2026, the Taiwan Food and Drug Administration (TFDA) announced the Good Machine Learning Practice (GMLP): Development and Management Principles for Artificial Intelligence Medical Devices, providing a lifecycle management framework for AI-enabled medical devices. The guidance outlines 10 key principles covering product design, data quality, clinical evaluation, human oversight, cybersecurity, and post-market monitoring, while further aligning Taiwan's regulatory expectations with international AI medical device frameworks.

• 2026-06-26 06:09:06

On 20 May 2026, HSA held a virtual industry briefing to present regulatory updates and support initiatives for medical devices and in vitro diagnostics (IVDs). The session covered revised guidance for software medical devices, updated Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0), audit reporting requirements, regulatory reliance with Malaysia's Medical Device Authority (MDA), reclassification of COVID‑19 IVDs, restructuring of IVD cluster grouping and a registration support initiative for unregistered devices.

• 2026-06-26 05:47:17

The Medical Device Authority (MDA) of Malaysia has published a new guidance document, Change Management for Registered Medical Devices (MDA/GD/0072). The guidance document will replace the current guidance document, Change Notification for Registered Medical Devices (MDA/GD/0020) and will be implemented following the official launch of MedCAST 3.0. Until such implementation takes effect, the current guidance document, MDA/GD/0020, shall remain applicable and in force.

• 2026-06-26 05:27:53

Commission Implementing Regulation (EU) 2026/977 establishes uniform quality management and procedural requirements for notified bodies designated under MDR (EU) 2017/745 and IVDR (EU) 2017/746. The Regulation aims to harmonize conformity assessment practices, improve transparency and predictability, and ensure consistent treatment of manufacturers across the European Union.

• 2026-05-28 01:39:58

Thai FDA has published the guideline for registration of custom-made dental medical devices, allowing manufacturers to rely on raw material technical evidence, rather than submitting finished product performance evidence for each individual custom-made device.

• 2026-05-27 01:54:19

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.