• 2026-05-27 09:53:25

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.

• 2026-04-28 08:33:22

The Medical Device Authority (MDA) has published the latest edition of the guidance document Definition of Medical Device which provides additional clarification on the definition and regulatory interpretation of medical devices, including accessories, components, and spare parts. The document is intended to assist industry stakeholders in the proper identification of device classifications and ensuring compliance with the Medical Device Act 2012 (Act 737).

• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.

• 2026-01-30 04:29:37

The European Union has established post-market surveillance (PMS) requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure the continuous safety and performance of medical devices and IVDs placed on the market. This framework emphasizes proactive monitoring, data collection, and lifecycle-based compliance to promptly identify and address potential risks.

• 2025-12-26 03:50:42

The Thai FDA has issued new Clinical Evaluation Report (CER) guidance that fully adopts the IMDRF framework without modification. As a result, IMDRF-compliant CERs can be used for Thai submissions with minimal administrative adjustment, supporting regulatory harmonization and reduced duplication.

• 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.