“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.
More 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.
More HSA is issuing Safety Alerts for all medical devices employing 5G modem due to the arising 5Ghoul Cybersecurity Vulnerabilities.
More The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.
More Following the industrial consultation earlier this year, Cyber Security Agency (CSA) of Singapore is launching Sandbox as a voluntary trial program for Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)). This program started on 20th October 2023 and will be held for 9 months. CSA is inviting medical device manufacturers to participate in Sandbox to have a first-mover advantage in enhancing the security of their products.
The Sandbox allows all parties involved to test out and give feedback on the requirements and application process for the CLS(MD) ahead of the scheme’s launch. Along with the launch of Sandbox program, CSA also published intensive set of regulations related to the requirements and implementation of CLS(MD).
Advancements in digital health technologies include the integration of AI and Machine Learning. These technologies are rapidly evolving and have a significant impact on the healthcare industry. The US FDA has released an update regarding the draft guidance they introduced on Predetermined Change Control Plans (PCCP).
More The TGA is launching an initiative known as the Medical Devices Vigilance Program (MDVP). This program will kick off with a 12-month pilot phase, strategically crafted to assist medical device sponsors in adhering to regulations and assuring the Australian public that sponsors are fulfilling their obligations.
More In September 2023, a circular letter issued by Indonesia’s Ministry of Health recommended that distributor license owners conduct post-market testing independently on circulated products. Products with submitted independent post-market test results which are within qualifications will receive a priority benefit in the e-Katalog system.
More Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.
More 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.
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