Connect.raps.org

Meet the Authors: Nutrition, Health, and Disease: …

WebRAPS first of its kind e-book, Nutrition, Health, and Disease: Regulatory Policy Matters, is a practical source depicting the importance of nutrition and the gut …

Actived: Just Now

URL: https://connect.raps.org/events/event-description?CalendarEventKey=8cd365fe-9af2-41cf-97cb-19fb816ff8d7&Home=%2Fhome

Regulatory Challenges, Prospects, and Modern Solutions

WebThe evolving regulatory landscape presents both opportunities and challenges, centered around the use and analytics of real-world data (RWD). We’ll …

Category: Health Go Health

Summary Reports for Medical Devices

WebTimelines for preparing summary reports. Summary reports must be prepared as follows: for medical device licence holders of Class II devices: every 2 years with …

Category: Medical Go Health

Complaint Handling and Reporting

Web4. RE: Complaint Handling and Reporting - MDR - Serious Public Health Threat. It is generally understood as a single incident, e.g. a customer complaint which is …

Category: Health Go Health

Sample template for a Health Canada Class III/IV Medical …

Web1. Sample template for a Health Canada Class III/IV Medical Device Regulatory Change Assessment

Category: Medical Go Health

Software as a Medical Device (SaMD) (June 2023)

WebSoftware as a Medical Device (SaMD) (June 2023) When: Jun 14, 2023 from 09:00 to 17:00 (ET) Navigating the regulatory expectations for software-based products …

Category: Medical Go Health

Health Canada Screening and Review Timelines

WebRE: Health Canada Screening and Review Timelines. Health Canada's target of 15 days to screen a Class III licence application (non-COVID-19 related) is definitively …

Category: Health Go Health

Current timeline for Health Canada review of an Investigational

WebHi Lucas, From my experience, they are staying very close to the full 30 calendar days to review an ITA application to "first decision". This means that usually on …

Category: Health Go Health

Health Canada Regulatory Open Forum

WebThis is based on Health Canada's CMDR definition: A person who sells a medical device under their own name, or under a trademark, design, trade name or other …

Category: Medical Go Health

Libya Medical device registration Regulatory Open Forum

WebThe General People's Committee for Health and Environment (GGCHE) is the responsible party for all health services in Libyia. The registration procedure hast he …

Category: Health Go Health

Health Canada Medical Device License Amendment

WebDirector Regulatory Affairs, Medical Devices. Cell phone: 519-242-6476. Fax: 888-887-8686. Vacation Alert: Out of office Friday July 1, 2022, Happy Canada Day! …

Category: Medical Go Health

License Amendments to Health Canada for Class II Devices

Web1. License Amendments to Health Canada for Class II Devices. in the case of a Class II medical device other than a decorative contact lens, a change in the medical …

Category: Medical Go Health

Health Canada Summary Report- When to Submit

WebThis message was posted by a user wishing to remain anonymous. Summary reports to Health Canada are required to be submitted when there has been a …

Category: Health Go Health

Health Canada MDD to MDR Transitioning Regulatory Open Forum

WebI am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most …

Category: Health Go Health

Simplified IMPD (sIMPD) for a marketed drug product requirement …

WebThis message was posted by a user wishing to remain anonymous Dear RA Folks: My company is planning to initiate a Phase 1 combination oncology drug trial in EU.

Category: Health Go Health

France raising MDR/ IVDR concern at EPSCO (Health) in Brussels …

WebRE: France raising MDR/ IVDR concern at EPSCO (Health) in Brussels 30th Nov 2023. The figures presented at the meeting of the Medical Device Coordination …

Category: Medical Go Health