• 2026-10-26 09:03:49

Australia's Therapeutic Goods Administration (TGA) updated its application audit selection criteria guidance, placing heightened pre-market focus on gynaecological curettes under Criterion 3 (Post-market signals). This article outlines how active post-market signals directly trigger non-mandatory application audits for medical devices, details the mandatory audit conditions under Regulation 5.3, and provides practical submission strategies for sponsors seeking Australian Register of Therapeutic Goods (ARTG) inclusion.

• 2026-09-21 02:28:25

Australia's Therapeutic Goods Administration (TGA) updated its application audit selection criteria guidance, placing heightened pre-market focus on gynaecological curettes under Criterion 3 (Post-market signals). This article outlines how active post-market signals directly trigger non-mandatory application audits for medical devices, details the mandatory audit conditions under Regulation 5.3, and provides practical submission strategies for sponsors seeking Australian Register of Therapeutic Goods (ARTG) inclusion.

• 2026-08-25 08:32:41

Singapore's Health Sciences Authority (HSA) has extended the compliance date for Phase 3 implementation of Unique Device Identification (UDI) requirements from 1 November 2026 to 31 December 2026. Class C General medical devices and in vitro diagnostic (IVD) medical devices must therefore carry UDI labelling prior to import and supply in Singapore from 1 January 2027.

• 2026-06-26 04:47:11

Australia's Unique Device Identification (UDI) system is moving from concept to reality, with the first mandatory compliance deadlines commencing in July 2026. Designed to strengthen patient safety, device traceability, and post-market surveillance, the phased implementation will introduce new obligations for both manufacturers and sponsors. This article explores how UDI works, key TGA compliance milestones, and what medical device companies should do to prepare.

• 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

• 2025-10-27 02:53:36

The Malaysian Medical Device Authority (MDA) has been recognized as an Affiliate Member of the Medical Device Single Audit Program (MDSAP). MDA will now accept MDSAP audit reports and certificates as evidence of QMS compliance, streamlining device registration and reducing audit duplication for manufacturers.

• 2025-04-24 06:13:27

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.

• 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

• 2025-01-22 07:16:29

This guidance provides detailed instructions on assigning Master Unique Device Identification Device Identifiers (Master UDI-DIs) to contact lenses.