• 2022-10-25 03:47:11

The OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.

• 2022-10-25 07:32:01

In Australia, the “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)” and the “Reduction of Assessment Fees for Medical Devices Guideline”, both outline specific situations in which the assessment procedures and the assessment costs for medical devices may be reduced.
The guideline provides details on the criteria and the eligibility for TGA to determine whether the process can be reduced for application audit assessments and conformity assessments involving medical devices (including IVDs).

• 2022-10-25 07:28:38

NMPA decided to start using electronic payment for drug and medical device registration fees.

• 2022-10-25 07:24:41

Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.

• 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 06:47:43

MDCG 2022-14 is aimed to propose solutions to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.

• 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 03:59:10

PFDA announced that alcohol swab product registrations will be transferred to the Center for Drug Regulation Research (CDRR). In the same month, PFDA also published a circular that aims to provide guidelines on the use of the FDA eServices Portal System for LTO applications of retailers of Medical Devices.

• 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.

• 2022-10-24 09:56:11

TFDA has recently announced a specific product registration guidance for AI/ML-based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software. Through the application of AI and ML-based technologies in detective or diagnostic medical devices, these kinds of products could be essential for medical personnel by decreasing required reading time with better diagnostic performance.