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Want to learn how to get your medical devices to market faster and with fewer risks? In this article we cover 6 software solutions by RegDesk that address the most common challenges faced by regulatory affairs teams and reveal how most companies are making the medical...
Asia
The present article describes in detail a new resolution issued in Jordan, by the virtue of which the authority describes the medical device license renewal procedure. Table of Contents Jordan has adopted a new circular resolution establishing the...
China
Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the classification of general medical devices. The document describes in detail the applicable classification rules...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed...
Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
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