• 2023-06-28 09:59:48

Qualtech's big topic for this month's edition provides an overview of the Unique Device Identification (UDI) system implemented by territories serviced by Qualtech for medical devices. The UDI system aims to improve patient safety, traceability, and identification of medical devices on the market. The implementation of the UDI system offers benefits such as faster traceability, standardized post-market safety activities, and improved buying and waste disposal policies.

• 2023-06-28 09:52:24

The Therapeutic Goods Administration (TGA) created a plan to help Australian medical device sponsors and stakeholders transition to the new EU Medical Device Regulation (MDR). The EU then extended the transition period, so the TGA reviewed its original plan. An updated strategy guideline has been published by the TGA regarding the transition and reclassification of certain medical devices.

• 2023-06-28 09:46:17

Correction action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.

• 2023-06-28 09:43:30

Center for medical device evaluation (CMDE) revised "Guidance for Registration of Intense Pulsed Light Equipment" and "Guidance for Registration of Ophthalmic Optical Instrument".

• 2023-06-28 09:38:06

This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

• 2023-06-28 07:48:07

This guidance aims to provide a clear understanding of what changes to design or intended purpose would be considered 'significant'. It also provides several flowcharts in order to facilitate a harmonised judgement of the significance of a change.

• 2023-06-28 07:35:36

HSA would like to consult the industry/stakeholders regarding updates and revisions of GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (R3). The key update includes clarification notes on the classification of control materials and software, also clarifications to the risk classification rules 1-5. The consultation period is open from 2-30 May 2023 through email to HSA.

• 2023-06-28 07:24:11

The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices

• 2023-06-28 07:14:09

The Circular 10/2023/TT-BYT was issued on May 11, 2023, amending some templates of the Circular 19/2021/TT-BYT, which was combined with the Decree 98/2021/ND-CP.

• 2023-05-30 02:10:17

1. Qualtech is Part of Your Team

Given the constantly changing medical device regulatory environment, Qualtech is ready to be an essential part of your RA team. That is, we provide you with one-stop services to navigate you through the different global markets and to expedite your regulatory approvals in your target countries.