Top Industry News
- EMA- First Guidance on New Rules for Certain Medical Devices
- Health Canada- Master Files (MFs) - Procedures and Administrative Requirements
- Swissmedic- Correction of the new eCTD specification documents Swiss M1 Specification and Swiss eCTD Validation Criteria (Update)
- TGA- Transition to ISO 13485:2016 Comes to an End
- Health Canada- Notice - Mandatory use of the Electronic Common Technical Document (eCTD) format
- Health Canada-Draft Health Canada IMDRF Table of Contents for Medical Device Applications Guidance
- EMA- Procedural Update on Submission of Type I variations to EMA in March, April and May 2019
- TFDA- The Cosmetic Hygiene and Safety Act Creates a New Era of Cosmetics Management
- FDA- Refuse to Accept Policy for 510(k)s
- DMA- New EU Report on Big Data Paves the Way for Action
- FDA- Quality Considerations for Continuous Manufacturing
- MHRA- In Vitro Diagnostic Medical Devices: Guidance on Legislation
- FDA Finalizes Guidance on 503B Bulks List
- MHRA- Medical Devices: How to Comply with the Legal Requirements