Medical Device Regulation Harmonisation

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Medical Devices; Quality System Regulation Amendments

https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments

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 …

Quality System (QS) Regulation/Medical Device Good …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3 (l) …

Proposed Rule: Quality System Regulation Amendments …

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions

On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) …

Harmonised standards - Public Health

https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en

Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the …

International Regulatory Harmonization | FDA

https://www.fda.gov/drugs/cder-international-program/international-regulatory-harmonization

International Council for Harmonisation The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is …

Regulation and Prequalification - World Health Organization

https://www.who.int/teams/regulation-prequalification/regulation-and-safety/regulatory-convergence-networks/harmonization

Regulation and Prequalification. Harmonization of technical requirements for medicines regulation, i.e., legislations, technical guidelines, procedures, etc., is a basis for …

Medical Device Regulation: The Need for …

https://lifesciences.csoftintl.com/blog/regulation-of-medical-devices-the-need-for-global-harmonization/

The medical device industry is one of the most complex and rapidly evolving sectors of the health sciences field. Dynamic innovation in medical devices has helped …

Global Medical Device Regulations

https://www.oliverhcp.com/news-and-resources/packtalk/global-medical-device-regulations-harmonization-efforts-of-sterile-medical-packaging-standards

There are several global and regional regulatory agencies who are working towards medical device regulatory harmonization internationally. These agencies …

Harmonized Standards List - Medical Device Regulation

https://www.medical-device-regulation.eu/mdr-resource-harmonized-standards-lis/

EN ISO 17664:2004 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) EN …

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