Medical devices are evolving and embracing the technologies, so are the Regulatory pathways to govern them. To add to the same, the Brazilian national Health Authority – ANVISA, has published a guidance dedicated to the software with the intended medical purpose (Software as Medical Device – SaMD).
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November 19, 2020 Medical Devices -
November 19, 2020 Medical DevicesBrazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação).
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October 29, 2020 Medical DevicesRecently, the SFDA (Saudi Food and Drug Authority) has issued a guidance to clarify the e-IFU (electronic Information for Use) requirements for medical devices in Saudi Arabia.
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October 29, 2020 Medical DevicesAs you may know, the FDA (Food and Drug Administration) uses Medical Device Reporting (MDR) as one of the post-market surveillance tools, to monitor device performance, to detect potential device-related safety issues and to contribute to benefit-risk assessment of the devices.
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October 22, 2020 Medical DevicesFace shields have gained utmost significance as the primary protective equipment to curb the spread of the COVID-19. Considered as a Personal Protective Equipment (PPE), face shield is made up of a transparent window or visor, that protects the face and associated mucous membranes (eyes, nose and mouth) against the potential exposure to infectious diseases.
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October 22, 2020 Medical Devices, Regulatory AffairsMultiple function device products are medical products that have at least one device function (medical) and one non-device function (non-medical) or other function. Among these, some are subjected to FDA’s Regulatory oversight as medical devices, while others are not.
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October 13, 2020 Medical DevicesSince the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries.
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October 13, 2020 Medical Devices, Regulatory AffairsCouple of months back we thoroughly discussed about FDA’s expedited Regulatory pathways during medical emergencies.
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October 13, 2020 Medical DevicesThe Mexican Regulatory Authority, COFEPRIS (The Federal Commission for Protection against Sanitary Risk) has established a new electronic appointment system for medical device registrants for submitting applications or seeking in-person meetings with the Agency.
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September 21, 2020 Medical DevicesMedical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In this rapid development scenario, to aid medical device manufacturers, notified bodies, and other stakeholders align with the sophistication and globalization, Regulatory bodies are parallelly revamping the compliance standards.