This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.
More Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.
More The Indonesian Ministry of Health recently issued guidelines to regulate the use of Medical Devices and Household Health Supplies through electronic systems. These guidelines, signed on 5 April 2024, offer crucial information for business actors, manufacturers, and distributors in the healthcare sector seeking to market their products in electronic systems.
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This article provides a comprehensive guide on TGA sponsors, a critical partner for medical device companies seeking to enter the Australian market. It explains the role of the Therapeutic Goods Administration (TGA) and how a TGA sponsor acts as a liaison, navigating the complex regulatory process to ensure compliance.
More The TGA is streamlining therapeutic goods recalls with phase two of its Recall Reforms. This initiative aims to achieve a dual benefit: reducing the regulatory burden on sponsors and strengthening public safety.
Sponsors will experience a simplified and more flexible reporting process, while the "Early Advice" program, allowing proactive communication with the TGA, will see enhanced communication protocols.
To promote consistent advertising practices across the medical industry, the TGA updated its guidelines for promoting cosmetic injectables.
More CMDE has issued a new notice, supplementing previous recommendations with updated clinical evaluation paths for specific medical devices, aiming to guide registration applicants effectively in navigating the regulatory process.
More This guidance provides detailed instructions to assist sponsors in preparing plans that fulfill regulatory expectations and streamline the assessment process by competent authorities.
More The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.
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