• 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 08:34:44

This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices

• 2024-03-01 08:29:27

Starting from 1 January 2024, Hong Kong Medical Device Division (MDD) has accepted on a regular basis marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and National Medical Products Administration (NMPA) of Mainland China to support the listing application of medical devices in Hong Kong.

• 2024-03-01 08:09:48

With Indonesia currently strengthening their regulations on Telecommunication Equipment Testing and Certification (including telecommunication medical devices), a Decree from the Head of BBPPT No. 36/2024 has been published concerning the Guidelines for Testing Services conducted at BBPPT (en: Telecommunication Device Testing Center)

• 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.

• 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

• 2024-03-01 05:58:09

Decision No. 04/QD-BYT dated January 2, 2024 of the Vietnam Ministry of Health assigning Conformity Assessment Bodies for evaluation of Common Submission Dossier Template.

• 2024-01-26 07:26:23

Reflecting on 2023, Qualtech experienced a dynamic and transformative year marked by regulatory webinars and the establishment of a new office in Korea. Amid challenges and celebrations, we fortified our commitment to excellence, setting the stage for continued growth and even greater achievements in the future. Join us in revisiting the highlights that shaped our journey.

• 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.