• 2022-11-29 03:04:45

As based on Japan's Ministry of Health, Labor and Welfare notice from September 20, 2022 the Essential Principles for certain Class II medical devices are amended.

• 2022-10-25 07:05:56

This document provides borderline cases and classification cases, for which the competent authorities of the Member States find difficulty regarding the uniform application of the regulations.

• 2022-10-25 06:38:16

The MDA published the First Edition of the Guidance Document of the "Harmonized Classification of Medical Devices in ASEAN" (MDA/GD/0062) on September 5, 2022. This guidance document provides the harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices, based on their intended use or purpose as claimed by the manufacturer.

• 2022-10-25 03:34:27

To provide a better understanding of the classification of medical-related software devices, TFDA has updated the existing guidance with some examples of SaMD and non-SaMD software. This article provides you with a quick insight into defining medical-related software devices.

• 2022-09-27 08:40:58

Matters concerning the filing of Class I medical devices (including Class I IVDs) are announced. The relevant documents are attached as well.

• 2022-07-26 11:26:52

According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.

• 2022-06-29 02:17:39

In April 2020, the Medical Device Authority (MDA) has issued a new Guidance Document regarding the classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices (MDA/GD/0061). This document guides the manufacturers and authorised representatives on classifying rehabilitation, physiotherapy, and speech therapy as medical devices.

• 2022-04-27 11:34:25

The US FDA is classifying the interoperable automated glycemic controller into class II. Also, the codified language for the interoperable automated glycemic controller is taken as a part of the device to the special control.

• 2022-02-18 09:29:35

Since January 18th, 2022, FDA formally classified the electrocardiograph software for over-the-counter use as class II (special controls).

• 2022-02-18 08:16:14

Hong Kong's MDD has announced a few changes in the trial schemes on the acceptance of some reference agencies approval. MDD also announced the regularization of the expedited approval scheme for Class II/III/IV General Medical Devices.