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FDA Guidance on Recalls RegDesk

WebThe Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for marketing approval and post-market monitoring and surveillance …

Actived: 7 days ago

URL: https://www.regdesk.co/fda-guidance-on-recalls/

FDA Guidance on PRO Instruments: Best Practices RegDesk

WebThe Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document …

Category: Food Go Health

EU MDR overview: An Update to European Medical Device …

WebRegulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746, has been published. The …

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

HSA Guidance on IVD Classification RegDesk

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

Category: Health Go Health

HSA Guidance on Medical Device Registration: Basics

WebSep 9, 2021. The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a detailed guidance document describing …

Category: Health Go Health

Health Canada Guidance on Incident Reporting RegDesk

WebMar 20, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published updated guidance on incident reporting for medical devices. The …

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

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

HSA Guidance on the Reporting of Adverse Events: Overview

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

Category: Health Go Health

An Overview of Medical Device Regulations in Belgium RegDesk

WebFeb 8, 2019. In Belgium, the regulation of medical devices is carried out by the Federal Agencies for Medical and Health Products (FAMHP). Like the rest of the European …

Category: Medical 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

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

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 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

SAHPRA Guidelines on Establishment Licensing: Costs, Documents, …

WebThe South African Health Products Regulatory Authority (SAHPRA), a country’s agency in the sphere of medical devices, has published the guidelines …

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 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

HSA Revised Guidance on Medical Device Product Registration: …

WebThe Health Sciences Authority (HSA), Singapore’s regulating authority on healthcare products, has published a revised guidance document dedicated to medical …

Category: Medical Go Health