The article describes in detail the approach to be applied with respect to clinical evidence the parties responsible for medical devices are expected to provide when applying for marketing approval.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for submissions related to in vitro diagnostic (IVD) medical devices intended to be marketed and used in the country.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The document describes the use of ASEAN CSDT with respect to IVD products and highlights the key points to be considered.
The scope of the guidance covers, inter alia, the aspects related to clinical evidence, including its robustness and trustworthiness.
Clinical Evidence: Overview
First of all, the authority states that the clinical evaluation of medical devices is vitally important for ensuring their safety and proper performance.
Such evaluations can emerge from a systematic review of existing bibliography, clinical experiences related to the same or similar devices, or by conducting a clinical investigation.
It is also important to mention that devices with a higher risk or those new to the market often require more rigorous clinical investigations.
Use of Existing Bibliography
In accordance with the applicable regulatory requirements, medical device manufacturers may rely on literature studies when preparing evidence to support the relevant claims on safety and efficiency.
These references, presented chronologically, should be recent and pertinent.
Clinical evidence, be it derived from local explorations or international studies or sourced from peer-reviewed scientific literature, must be submitted with precision. This involves an in-depth description of objectives, methodology, and results, followed by an exhaustive discussion and conclusion.
In summary, the present HSA guidance outlines the requirements to be taken into consideration by the parties responsible for medical devices with respect to the clinical evidence they are expected to provide in order to support the relevant claims. The document outlines the scope of evidence to be provided, and also outlines the key aspects associated thereto.
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