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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 …

Actived: 5 days ago

URL: https://connect.raps.org/discussion/summary-reports-for-medical-devices-health-canada

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

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 …

Category: Nutrition Go Health

Heath Canada License for Medical Device Class II Regulatory …

WebHi Everyone! My company has submitted a Class II medical device license request to Health Canada. After our initial submission, Health Canada posed some …

Category: Medical Go Health

Health Canada Screening and Review Timelines Regulatory Open …

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

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 is particularly …

Category: Medical 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

Indonesia's MoH Introduces a New Medical Database

WebPosted 31-Oct-2022 16:11. Indonesia's Ministry of Health initiated a "Pharmacy and Medical Device Dictionary" which amounts to a public database of drugs and devices in …

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

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

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

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