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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...
MFDS Amended Submission Requirements
The Ministry of Food and Drug Safety (MFDS), Korea’s national authority responsible for medical device regulation (previously known as Korea Food and Drug Administration or KFDA) issued an update to the requirements...
EC MDCG Issues Notified Body Assessment Form
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued a final version of the assessment form intended to be used by designated authorities to select a notified body. Notified Bodies and...