• 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.

• 2024-01-26 06:58:53

This guidance explains the qualification and classification of products without an intended medical purpose listed in Annex XVI of the MDR.

• 2024-01-26 06:51:35

This guidance provides demonstration of equivalence for products without an intended medical purpose listed in Annex XVI of the MDR.

• 2024-01-26 06:44:31

“Guidance Notes (GN-10) on Changes for Listed Medical Devices” has been issued by Hong Kong MDD on 30th November 2023 which aim to assist the Local Responsible Persons (LRP) in categorizing, managing and reporting changes of listed medical devices. This guidance has been effective since 1st January 2024.

• 2024-01-26 06:28:31

Telecommunication technologies or devices in Indonesia, including telecommunication medical devices, should apply for Certificate of Telecommunication Device. In order to comply with this requirement at this moment, Indonesia MoH encourages manufacturer of medical devices with Bluetooth and RFID feature to voluntarily submit either Certificate of Telecommunication Device or Declaration Letter confirming the proposed product will apply for this certification during pre-market application.

• 2024-01-26 05:18:26

The Medical Device Authority (MDA) published a second edition guidance document on “Guidance on Harmonised Borderline Product in ASEAN" on December 23, 2023. This guidance document provides a list of borderline products, whether they are medical devices or non-medical devices, based on their intended purpose as claimed by the manufacturer, which is harmonised in ASEAN. This guidance document will be updated on a yearly basis to reflect the latest decisions of the ASEAN Medical Device Committee (AMDC).