• 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.

• 2025-01-22 03:51:46

Medical Device Cluster (MDC) is rolling out the pilot run for the Change Management Program (CMP) for Software as Medical Device (SaMD), also known as a Standalone medical mobile application, including Machine Learning-Enabled SaMD. The program is voluntary and incorporated into HSA's existing Premarket Product Registration and Change Notification process. With effect from 4 December 2024, HSA also published new guidance document (GN-37) for the program.

• 2025-01-22 03:25:25

The US FDA has released a minor update of its final guidance, Global Unique Device Identification Database (GUDID) – Guidance for Industry and FDA Staff. This update incorporates forthcoming changes to the Global Medical Device Nomenclature (GMDN) field within the GUDID, along with other minor clarifications.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 2023-10-20 06:18:18

The previously-announced 3-stage timeframe for UDI system implementation on Class II and Class III medical devices has now taken full effect in Taiwan. Qualtech reminds all partners to take note of the related UDI requirements.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.

• 2023-06-28 09:59:48

Qualtech's big topic for this month's edition provides an overview of the Unique Device Identification (UDI) system implemented by territories serviced by Qualtech for medical devices. The UDI system aims to improve patient safety, traceability, and identification of medical devices on the market. The implementation of the UDI system offers benefits such as faster traceability, standardized post-market safety activities, and improved buying and waste disposal policies.

• 2023-03-27 10:02:31

The UDI of specific categories of class II medical devices is going to be implanted. In this announcement, the list of medical devices which require a UDI is provided and the relevant progress and requirements are announced.

• 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.