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The NITI Aayog on Indian Medical Device Regulations
Indian policy thinktank NITI Aayog has not denied proposals to classify medical devices under the Central Drugs Standard Control Organization (CSDCO), but pushes instead for the implementation of new laws to regulate...
Slovenia Implements New Packaging Requirements
The new regulation adopted in Slovenia implements the labelling requirements set forth in the Commission Delegated Regulations 2016/161/EC supplementing Directive 2001/83/EC. The regulation provides detailed rules on...
CDRH Implements Surveys on Medical Device Shortages
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on...