• 2024-03-01 08:59:50

The CMDE has compiled the medical device registration review guideline catalog published from 2007 to 2023.

• 2024-03-01 07:14:04

The Medical Device Authority (MDA) published the Second edition Guidance Document, "Guidance on General Medical Device", on January 30, 2024. This guidance document provides aims to help determine the appropriate grouping for medical devices in the medical device registration application. This document applies to all products that fall within the definition of medical device that has been specified in the Guidance Document: Definition of Medical Device (MDA/GD/0006) excluding In-vitro Diagnostic Medical Device.

• 2024-01-26 07:14:49

The NMPA has revised the Quality Management Standards for Medical Device Operation. This article summarized the critical points of the revision.

• 2024-01-26 07:08:51

A regulation on the management of emergency use of medical devices (trial) is issued.

• 2024-01-26 06:44:31

“Guidance Notes (GN-10) on Changes for Listed Medical Devices” has been issued by Hong Kong MDD on 30th November 2023 which aim to assist the Local Responsible Persons (LRP) in categorizing, managing and reporting changes of listed medical devices. This guidance has been effective since 1st January 2024.

• 2024-01-26 06:28:31

Telecommunication technologies or devices in Indonesia, including telecommunication medical devices, should apply for Certificate of Telecommunication Device. In order to comply with this requirement at this moment, Indonesia MoH encourages manufacturer of medical devices with Bluetooth and RFID feature to voluntarily submit either Certificate of Telecommunication Device or Declaration Letter confirming the proposed product will apply for this certification during pre-market application.

• 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

• 2024-01-26 04:02:59

HSA is issuing Safety Alerts for all medical devices employing 5G modem due to the arising 5Ghoul Cybersecurity Vulnerabilities.

• 2024-01-26 03:40:25

The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.

• 2023-12-26 03:54:32

Starting 1st December 2023, advertisement applications received in hard copy will not be accepted as all completed advertisement applications shall be sent via email to MDA.