The US FDA issued a draft guidance for medical devices that have relation to Weight Loss. The purpose of this guidance is to provides recommendations for both clinical and non-clinical testing to support premarket submissions.
More NMPA revised the Catalog of Medical Devices Exempt from Clinical Evaluation (2021) and published the Catalog of Medical Devices Exempt from Clinical Evaluation (2023).
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Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.
More The Australian government has extended medical device reform deadlines due to the EU MDR transition, enabling manufacturers to obtain EU MDR certificates and sponsors to engage with the TGA under the new regulations until July 1, 2029. This adjustment aligns with the EU MDR transition's conclusion on December 31, 2028.
More The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.
More 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.
More 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.
More 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>.
More 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.
More 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.
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