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Laws Regulating Mobile Health Apps RegDesk Professional …

WEBThe digital health field is regulated by the FDA under four important laws. Firstly, the Health Insurance Portability and Accountability Act (HIPAA) protects the …

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URL: https://www.regdesk.co/laws-regulating-mobile-health-apps/

FDA Guidance on Recalls RegDesk

WEBThe guidance further describes voluntary as per regulation 21 CFR 7. The Agency states that voluntary recall is an alternative to the removal of medical devices …

Category: Medical Go Health

Current Medical Device Regulations in Canada RegDesk

WEBCanadian Regulation for Medical Devices. In Canada, the regulation of medical devices is overseen by Health Canada. The regulatory framework is based on …

Category: Medical Go Health

Health Canada Guidance on Risk Management for Medical Devices

WEBJul 16, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated …

Category: Medical Go Health

The Importance of Medical Devices in Healthcare RegDesk

WEBMedical devices are an important aspect of healthcare as they help diagnose, monitor, and treat a wide range of medical conditions. These devices include everything …

Category: Medical Go Health

Health Canada Draft Guidance on Significant Changes: Overview

WEBHealth Canada, the country’s regulatory agency in healthcare products, has published a draft guidance document dedicated to interpreting “significant change ” of a …

Category: Health Go Health

Health Canada Guidance on Medical Device Recalls: Process …

WEBHealth Canada, a country’s regulating authority in healthcare products, has published a guidance document dedicated to recalls. The document provides an …

Category: Health Go Health

Health Canada Guidance on Inspections: Advertising, Labelling

WEBIn summary, the present Health Canada guidance describes the way the inspector will assess compliance with the specific regulatory requirements set for by the …

Category: Health Go Health

Health Canada announces REP Expansion RegDesk

WEBHealth Canada announces REP Expansion. Jun 4, 2020. The Health Products and Food Branch of Health Canada, the Canadian regulating authority in the …

Category: Food Go Health

Global Medical Device UDI Requirements: A Quick Reference …

WEBThe use of medical devices is essential in healthcare, with millions of devices being used globally each year. As the number of devices continues to grow, tracking and …

Category: Medical Go Health

Health Canada Guidance on License Application Types RegDesk

WEBJul 23, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the types of medical device …

Category: Medical Go Health

HSA Guidance on Medical Device Advertisement: Basics

WEBSep 13, 2021. The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to …

Category: Health Go Health

Consultation on Changes to Canadian Medical Device Regulations

WEBHealth Canada, the country’s regulating authority in the sphere of healthcare products, has announced a consultation for proposed amendments to the Medical …

Category: Medical Go Health

HSA Revised Guidance on Medical Device Product Registration: …

WEBThe Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a revised guidance document dedicated to …

Category: Health Go Health

Health Canada Guidance on Recalls: Basics RegDesk

WEBJul 22, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The …

Category: Medical Go Health

Canada’s Cybersecurity Requirements for Medical Devices

WEBCanada’s Cybersecurity Requirements for Medical Devices. Jun 28, 2019. Health Canada, the Canadian medical regulating authority, announced that new …

Category: Medical Go Health

Health Canada Increases Regulatory Prices of Medical Devices

WEBJun 14, 2019. Health Canada recently stated that their regulatory fees of medical devices will increase significantly. Overall, the regulatory cost increased by 43%. Stakeholders of …

Category: Medical Go Health

Health Canada Guidance on MDEL: Annual Review, Updating

WEBHealth Canada Guidance on MDEL: Annual Review, Updating, Cancellation, and Suspension. Jun 21, 2021. Health Canada, the country’s regulating authority in the …

Category: Health Go Health

HSA Guidance on Medical Device Advertisements and Sales

WEBThe Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the …

Category: Health Go Health