The article highlights the critical points related to the regulatory requirements for quality management system audits and certification.
RegDesk Regulatory Roundup
The article highlights the critical points of the new classification approach to spinal implantable medical devices.
The article highlights the key points related to the regulatory status of boundary products in Australia.
The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including in vitro diagnostic ones) for abridgement of TGA conformity assessments and as information required for applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...