Asia
The new article highlights the aspects related to the specific provisions of the current legislation by the device of which the reliance mechanism is implemented into the existing regulatory framework. The article also describes the main principles to be followed when...
Asia
The new article addresses the aspects related to possible changes to an existing license, including the transferring local representative, renewal, and manufacturer acquisition. Table Of Contents: The National Health Regulatory Authority (NHRA), a Bahrain’s agency...
EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
FDA
The article provides an overview of the regulatory requirements related to the actions to be taken by the authority and/or applicant in the context of premarket notification, and the effect such actions will have on the review timelines. Table Of Contents: The Food...
Saudi Arabia
The new article addresses the aspects related to the quality management system in the context of medical devices based on innovative technologies. Table of Contents The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of healthcare...
Asia
The article highlights the key points related to the regulatory requirements for the online importation approval process. Table Of Contents: The National Health Regulatory Authority (NHRA), Bahrain’s regulatory agency in the sphere of healthcare products, has...
