The purpose of this IMDRF guidance is to harmonize the documentation and procedures that are 60 used to assess whether a medical device conforms to the regulations that apply in each jurisdiction. The worldwide adoption of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.
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- ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
- Guiding principles on the use of large language models in regulatory science and for medicines regulatory activities
- IMDRF Document Implementation Report
- Acceptable Media for Electronic Product User Manuals
- FDA final guidance on ‘Electronic Submission Template for Medical Device De Novo Requests’
- Cyber security in the health and medicine sector: a study on available evidence of patient health consequences resulting from cyber incidents in healthcare settings
- ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms – Scientific guideline
- EUDAMED user guide NRDs (Custom made and Old devices) for the Vigilance module