• 2022-06-29 02:24:35

The Malaysia Medical Device Authority (MDA) released the 2nd Edition of Guidance on The Rules of Classification for General Medical Devices MDA/GD/0009 on May 9, 2022.

• 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.

• 2022-06-29 02:14:40

MDCG 2022-6 provides clarifications on the concept of ‘significant changes in the design and intended purposes’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26th May 2022 during the transition period.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2022-04-27 11:32:12

Concerning the rapid development of Artificial Intelligent/Machine Learning-Based SaMD, TFDA has updated the related guidance that was initially announced in 2020. The latest requirements are summarzied in this article.

• 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

• 2022-03-25 11:49:26

The Medical Device Authority (MDA) produced this new Guidance Document to assist the medical device industry and healthcare practitioners in complying with the Medical Device Act (Act 737) and its regulations.

• 2022-01-26 10:39:04

Malaysia's Medical Device Authority (MDA) has published the Fourth Edition of its Guidance Document on Medical Device Labelling Requirements. This guidance document is beneficial in informing stakeholders about the additional requirements and materials that must be included in medical device labelling marketed in Malaysia.

• 2021-09-29 00:33:56

HSA recently issued updates to some pre-market registration-related guidance documents and technical reference documents. Specifically, the GN-15, GN-17, GN-18, TR-01, and TR-02 were updated. The changes mainly deal with the addition of cybersecurity requirements for medical devices. This is a very important update since it is imperative to protect devices that are used in the healthcare industry from hackers and other cyberthreats.

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.