• 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 06:50:55

This document offers a detailed Q&A guide on the progressive implementation of Eudamed, focusing on the gradual roll-out of Eudamed, obligations related to supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic medical devices.

• 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.

• 2025-01-22 03:13:13

On January 1st, 2025, the Vietnam Ministry of Health issued Decree No. 04/2025/NĐ-CP, extending the validity of import licenses for medical devices until June 30, 2025. This decree updates Clause 2, 3, and 4 of Article 76 in Decree No. 98/2021/ND-CP, as amended by Decree No. 07/2023/ND-CP. These changes aim to allow businesses to continue operations without interruption and ensure smooth operations in medical device management.

• 2024-12-16 10:35:14

Qualtech simplifies medical device registration and post-market compliance in China by addressing NMPA requirements with personalized guidance and localized expertise. From ensuring submission-ready dossiers to managing regulatory feedback and proactive surveillance, their support streamlines compliance, safeguards product reliability, and enhances market success.

• 2024-12-16 09:42:20

South Korea is transforming healthcare with AI, enabling personalized nutrition, early disease detection, and proactive health management. AI systems, like one that diagnosed lung cancer with 94% accuracy, showcase its potential. The technology also accelerates drug development, opening new opportunities for AI-powered medical device companies.

• 2024-12-16 09:17:34

The updated Therapeutic Goods regulations in Australia, effective October 19, 2024, introduce streamlined documentation for medical devices assessed by the US FDA. By aligning with international standards, the changes simplify compliance for Class IIa and Class III devices, reducing burdens while ensuring safety and quality, offering manufacturers faster market access.

• 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 08:32:04

Following the Industry Consultation held from 25 January to 10 March 2023 and Sandbox Phase conducted from October 2023 to July 2024, the CSA, in collaboration with MoH, HSA, and Synapse launches the Cybersecurity Labelling Scheme for Medical Device [CLS(MD)] for public applications along with a set of publications as guidelines for the applicants. The program opens for voluntary enrollment on 16 October 2024 as part of Singapore's effort to enhance cybersecurity awareness.

Manufacturers who wish to pursue one of the 4 cybersecurity levels should apply to Cybersecurity Certification Centre (CCC) through GoBusiness Licensing Portal https://www.gobusiness.gov.sg while inquiries can be sent to email: cls_md@csa.gov.sg.