Top Industry News
- FDA Electronic Submission Template for Medical Device 510(k) Submissions
- Malaysia’s MDA Updates Guide to Re-registering Medical Devices
- ANVISA Administrative Documents Must be Sent Through the SEI System
- ANSM Publishes New Rules for Good Preparation Practices
- FDA How to Obtain a Covered Product Authorization
- MHRA Notify the MHRA About a Clinical Investigation for a Medical Device
- FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
- MDCG Guidance on Appropriate Surveillance Regarding the Transitional Provisions Under Article 110 of the IVDR (September 2022)