• 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 07:00:59

This guidance provides instructions for sponsors on submitting clinical investigation reports and their summaries to Member States' competent authorities when EUDAMED is not fully functional.

• 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.

• 2024-12-16 08:47:55

This guidance clarifies the regulatory framework for the use of EtO in sterilizing medical devices and in vitro diagnostic medical devices.

• 2024-12-16 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

• 2024-10-10 09:23:31

The Medical Device Authority (MDA) announced the outcomes and implementation plan for the MDA-CAB 2023 Workshop held on December 6–7, 2023, as well as the current MDA-CAB 2024 Workshop Series I scheduled for March 1, 2024.

• 2024-10-10 08:46:48

HSA's Medical Devices Cluster has released a draft of Guidance on Change Management Program (CMP) for stakeholders with consultation period from 26 August 2024 to 21 October 2024. The new optional regulatory pathway aims to accommodate the rapid iterative nature of SaMD changes. This guidance explains on the CMP definition, scope, eligibility, requirements, and process. The guidance also introduces the concept of 'Pre-specified' changes. Feedback on the guidance draft can be sent to HSA through email by using prescribed feedback form.

• 2024-09-17 05:23:25

This guidance offers instructions on the clinical evaluation of orphan devices under the MDR.

• 2024-05-08 01:49:59

In April 2024, Hong Kong Medical Device Division has introduced the new Medical Device Information System, a one-stop e-service that allows online Medical Device Administrative Control System listing applications for medical devices and traders. It is highly recommended to familiarize with the new e-services, as we transition out of paper-based submissions.

• 2024-09-17 02:45:43

Medical devices often undergo numerous iterations to enhance the product based on real-world experience and feedback. These changes result in rebranded new products called Next Generation Medical Devices (NextGen MD). Health Sciences Authority (HSA) in Singapore has taken a proactive step by introducing the NextGen MD Initiative to facilitate the registration of next generation devices by streamlining the registration process to allow applicants to leverage data that has been submitted to HSA for registered devices.