• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

• 2023-07-21 03:58:08

Qualtech hosted a talk by Dr. Huang Wen-Chien on the evolution of minimally invasive lung cancer treatment. The advancements discussed included surgical tools, non-surgical techniques, and video-assistive technology. Qualtech also offers comprehensive Clinical Evaluation Report (CER) services to assist with medical device registration, drawing upon expertise in biomedical engineering and molecular biology to deliver high-quality reports for various regions.

• 2023-07-21 03:49:06

The Therapeutic Goods Administration (TGA) will no longer accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices after May 26, 2023. Only approved IVD medical devices supported by ISO 13485 certificates will remain valid until the certificate expires.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.

• 2023-07-21 03:04:45

The information regarding the qualified institutes for the testing according to GB 9706.1-2020 and YY 9706.102-2021.

• 2023-07-21 02:49:56

Hong Kong's Department of Health will adopt a new strategy taking effect on 21 June 2023, to give preference to medical devices (MD) listed under the Medical Device Administrative Control System (MDACS) in the procurement of all applicable medical devices.

• 2023-07-21 02:46:26

The Medical Device Authority (MDA) published the Third Edition Guidance Document, "On Guidance on Medical Face Mask and Respirator", on May 19, 2023. This document is intended to give clarity on medical face masks and respirators regulated by the Medical Device Act (Act 737). This document applies to establishments, healthcare facilities, and the general public who deal with medical face masks and respirators.

• 2023-07-21 02:38:16

The MDA announced a transition period for the implementation of electronic medical device registration certificates on May 22nd, 2023. This announcement is intended to provide information on the use of Electronic Medical Device Registration certificates, which will be fully implemented on January 1st, 2024, and no more physical medical device registration certificates will be issued by MDA.

• 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

• 2023-07-21 02:14:29

The US FDA recently issued an updated guidance aimed at providing comprehensive information on the recommended documentation for premarket submissions. The purpose of this guidance is to assist the FDA in evaluating the safety and effectiveness of device software functions.