Top Industry News
- SFDA- Guidance to Implement a Medical Devices Standard “Quality Management System" Regulatory Requirement (ISO 13485:2016)
- TGA- Labelling Changes: Information for Health Professionals
- FDA- Compliance Policy for Combination Product Postmarketing Safety Reporting
- FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions
- European Parliament Evens Scales for Generics Makers With New SPC Waivers
- FDA Finalizes Guidance on Convenience Kit UDI Marking
- FDA- Surgical Staplers and Staples for Internal Use - Labeling Recommendations