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2022 medical device regulatory guidance plans from US FDA

Regarding CDRH’s A list of guidance documents for 2022, the division plans to finalize guidance for clinical decision support software, postmarket … See more

Actived: 5 days ago

URL: https://www.emergobyul.com/news/us-fda-maps-out-medical-device-regulatory-guidance-planned-2022

Has it become vogue to leverage other regulators’ authorizations …

WEBMost recently, the UK Medicines Healthcare Regulatory Authority (MHRA) shared in their webinar (January 24, 2023) that Brexit facilitated their greater leveraging …

Category: Medicine Go Health

2023 annual report from US FDA medical device regulatory division

WEBThe US Food and Drug Administration’s (FDA) division overseeing medical devices has released its 2023 annual report showing a slight increase in device …

Category: Food, Medical Go Health

UI Design Trends for Healthcare and Medical Apps Emergo by UL

WEBHealthcare apps should be designed in a straightforward, intuitive way that allows the user to quickly understand how to use the app, whether that be for monitoring …

Category: Health Go Health

Canada Medical Device License and MDEL Consulting Emergo by …

WEBA Canadian Medical Device License (MDL) is required for companies selling Class II - IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit …

Category: Medical Go Health

Canadian regulators issue new reporting requirements for medical …

WEBDecember 5, 2021. Health Canada, the Canadian medical device market regulator, has published new guidance covering procedures and criteria for medical device …

Category: Medical Go Health

How FDA CDER defines critical tasks for human factors validation

WEBThere are some differences in how the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), focused on drug and combination products, and …

Category: Food Go Health

Medical Device and IVD Registration in Vietnam Emergo by UL

WEBUnder Decree No. 98/2021, medical devices and IVDs require a Marketing Authorization Code (MAC) to be imported and sold in Vietnam. With the publication of Decree No. …

Category: Medical Go Health

Details on Declaration Route for Class I Medical Devices in Israel

WEBBy Megan Gottlieb and Evangeline Loh. As Emergo by UL reported in August, the Ministry of Health in Israel, Medical Device Division, AMAR, announced …

Category: Medical Go Health

Mexico – Overview of Medical Device Industry and Healthcare …

WEBOverview of medical device industry: Mexico is the second largest medical device market in Latin America, following Brazil. With increasing health expenditure and the acquisition of …

Category: Medical Go Health

Health Canada Medical Device Classification Consulting

WEBHealth Canada device classification. Before medical device and in-vitro diagnostic (IVD) device manufacturers can legally sell their products in Canada, they must comply with …

Category: Medical Go Health

Medical Device Registration

WEBMexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission for Protection of Sanitary Risks …

Category: Medical Go Health

New Guidelines for Modifications to Medical Device Registrations …

WEBAugust 15, 2023. By Pedro Omar Sánchez Neri. Mexican medical device market regulator COFEPRIS has published updated guidance covering modifications to device …

Category: Medical Go Health

Canada Medical Device Market Overview

WEBThis short video tells you how. Topics covered include Health Canada, classification of products in Canada, quality system requirements and ISO-Canadian Registrars, …

Category: Health Go Health

Mexico's COFEPRIS

WEBThe Ley General de Salud, or General Health Law, is the regulation for importing and exporting medical products and food. COFEPRIS or the Federal Committee for …

Category: Food, Medical Go Health

MDSAP Compliance in Canada Emergo by UL

WEBAn Emergo quality system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets. In addition to ISO 13485 consulting, we …

Category: Medical Go Health

Health Canada Medical Device Adverse Event Reporting Emergo …

WEBHere are the basic steps you should follow in reporting an adverse event in Canada: Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance …

Category: Medical Go Health

Thailand FDA and Singapore HSA Regulatory Reliance Program

WEBOctober 20, 2023. By Sreenu Sattu. The Medical Device Control Division of the Thailand Food and Drug Administration (Thai FDA) has recognized the Singapore Health …

Category: Food, Medical Go Health

Vietnamese regulatory changes target higher-risk medical devices

WEBMarch 10, 2023. By Megan Gottlieb and Hugh Nguyen. The Vietnamese government has issued an amendment to the regulation on medical device registration. Decree No. …

Category: Medical Go Health