Asia
The Directorate General of Pharmaceutical Affairs and Drug Control, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements related to the registration of high-risk medical...
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to infusion pumps. The guidance highlights matters related to performance testing. It is important to...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to infusion pumps and regulatory matters associated thereto. The document addresses the most important...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control. The document covers the regulatory matters related to design verification and...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document on design control for medical devices. The document provides additional clarifications and recommendations to be...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to recalls. The document provides general information about recalls and also a detailed description of the main phases of the recall...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
