• 2025-09-24 07:40:52

PMDA has revised the approach to biological safety evaluation and abolished the previous notification issued on Jan 6, 2020. The revised approach focuses on providing practical instructions for preparing regulatory submissions.

• 2025-07-10 09:45:06

The Japanese Ministry of Health, Labour and Welfare is enforcing the implementation of the new JIS standard for Electromagnetic Compatibility (EMI/EMC) (JIS T 0601-1-2:2023) as of February 25, 2026.

• 2025-05-29 09:42:50

Malaysia Medical Device Authority (MDA) authority issues the new guidance documents of Importation of Medical Device for Re-export (IRE), MDA/GD/0069 in March 2025. This guidance document outlines the procedure for importing medical devices into Malaysia for re-export purposes. It is particularly beneficial for importers and manufacturers by providing clear regulatory steps, approval requirements, and compliance guidelines to facilitate smooth procedure.

• 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 03:25:25

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.

• 2024-12-16 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.

• 2024-11-04 05:15:38

The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices. It advises manufacturers to use targeted analytical techniques to identify and quantify chemical constituents, focusing on both device material composition and potential patient exposure.

• 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.

• 2024-10-10 08:07:48

The FDA launched the Voluntary Malfunction Summary Reporting (VMSR) program in 2018 to streamline the malfunction reporting process for medical device manufacturers. This initiative enhances the FDA's capacity to effectively monitor a diverse array of devices.