Medical Device Regulatory Authority

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International Medical Device Regulators Forum (IMDRF) …

https://www.fda.gov/medical-devices/cdrh-international-programs/international-medical-device-regulators-forum-imdrf

The International Medical Device Regulators Forum (IMDRF) is a group of medical device regulators from around the world that have voluntarily come together to harmonize the regulatory requirements ...

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Global Regulatory Authority Websites - PDA

https://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/global-regulatory-authority-websites

Korea: Food and Drug Administration (in Korean) Malaysia: Ministry of Health. Malaysia: National Pharmaceutical Regulatory Agency. New Zealand: Ministry of Health. New …

Medical Device Regulatory Authorities - Regulatory Convergence

https://www.interamericancoalition-medtech.org/regulatory-convergence/quick-links/medical-device-regulatory-authorities/

Brazilian National Health Regulatory Authorities. Agência Nacional de Vigilância Sanitária. Gerência-Geral de Tecnologia de Produtos para Saúde (GGTPS) ANVISA delegates to …

Overview of Regulatory Medical Device - Medical Device …

https://portal-cloud.mda.gov.my/ms/industry/overview-of-regulatory-medical-device.html

Overview of Regulatory Medical Device Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia which was established under the Medical …

National Medical Products Administration - NMPA

http://english.nmpa.gov.cn/

Xu Jinghe meets with CEO of Saudi Food and Drug Authority. Xu Jinghe, deputy commissioner of China's National Medical Products Administration, held talks with …

Medical Device Registration Authority Subscription, Malaysia

https://morulaa.com/medical-device-registration/medical-device-registration-regulatory-information-subscription/

The Medical Device Registration Authority of Malaysia (MDA), also known as Medical Device Authority-Regulatory Information Subscription, released a notice on …

Home - NMRC - GRN Portal - Gov

https://nmrc.gov.na/

To ensure safe, efficacious, quality medicines, related substances and medical devices for human and animal use in accordance with recognized international standards and …

HPRA process for Article 97 and notified body certificates

https://www.hpra.ie/homepage/medical-devices/regulatory-information/medical-devices-regulation/hpra-process-for-article-97-and-notified-body-certificates

HPRA process for Article 97 and notified body certificates What is Article 97? In December 2022, the Medical Device Coordination Group published guidance (MDCG 2022-18) on …

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