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Health Canada Framework for COVID-related Medical Devices

WebHealth Canada, the country’s regulating authority in the sphere of medical devices, has published guidelines on special framework for importation and sale of …

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URL: https://test.regdesk.co/health-canada-framework-for-covid-related-medical-devices/

Health Canada on Incident Reporting: Timelines and Content

WebHealth Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the …

Category: Medical Go Health

Health Canada Guidance on Clinical Evidence: Submission

WebHealth Canada, a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence …

Category: Health Go Health

Health Canada Guidance on Issue-Related Analyses for Medical

WebThe present Health Canada guidance details the regulatory requirements that summary reports should meet. According to the document, such a report shall …

Category: Health Go Health

Health Canada Guidance on Clinical Evidence: Comparator Devices …

WebHealth Canada, a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence. The …

Category: Health Go Health

Health Canada Notice on Interpretation of Significant Changes

WebHealth Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to …

Category: Medical Go Health

FDA Guidance on Supplements for PMA and HDE Submissions

WebThe Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket …

Category: Supplements, Food, Medical Go Health

Health Canada Guidance on Private Label Medical Devices

WebRegulatory Background The present Health Canada guidance describes how the interested party shall prepare an application for a new medical device license or an …

Category: Medical Go Health

Health Canada on Significant Changes: Guidance for Implementation

WebHealth Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to …

Category: Health Go Health

Health Canada Guidance for Private Label Medical Devices

WebApr 16, 2020. The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance dedicated to the application for a new license of making …

Category: Medical Go Health

TGA Guidance on Clinical Evidence RegDesk

WebThe Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published …

Category: Medical Go Health

CDRH Introduces New Learning Modules RegDesk

WebThe Center for Devices and Radiological Health (CDRH), the FDA division focused on ensuring the safety of medical devices available on the market, published …

Category: Medical Go Health

Japan Issues Updated Guidance on Biocompatibility Testing

WebThe Ministry of Health, Labour and Welfare of Japan (MHLW), the Japanese regulating authority responsible for medical device circulation, issued updated guidance …

Category: Medical Go Health

Indonesia’s MoH Introduces New Device Risk Classification System

WebThe MoH in Indonesia has released SIKLARA- a medical device risk classification system that lines up with AMDD. This system aims to be more user friendly, …

Category: Medical Go Health

Overview of the Medical Device Regulatory Market in Greece

WebMedical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health.Greece, as a member of …

Category: Medical, Medicine Go Health

Kazakhstan: New Medical Device Classification Rules RegDesk

WebThe National Center for Expertise of Medicines and Medical Devices (NDDA), a department of the Committee for Medical and Pharmaceutical Control of the …

Category: Medical, Medicine Go Health

The Lowdown on Medical Device Regulations in Sweden RegDesk

WebUntil recently, the main regulatory framework for medical devices in Sweden was based on the following three EU directives: Directive 90/385/EEC (Active …

Category: Medical Go Health

Australian Regulatory Guidelines for Medical Devices RegDesk

WebSep 2, 2020. The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining …

Category: Medical Go Health

Change Control: Ethiopian Guidance for Medical Devices

WebThe Ethiopian Food and Drug Authority (EFDA), Ethiopia’s national authority responsible for medical device regulation, has provided draft guidance regarding …

Category: Food, Medical Go Health