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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

Good manufacturing practice | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice
    Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines …

Guidance on good manufacturing practice and …

    https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers
    EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products. EU GMP guide annexes: Supplementary requirements: Annex 6: …

EudraGMDP database | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/eudragmdp-database
    GMP compliance certificate Wholesale distribution authorisation Registration of an active substance manufacturer, importer or distributor This applies to all EU and non-EU …

Good Manufacturing Practice (GMP’s) for Medical …

    https://www.presentationeze.com/blog/good-manufacturing-practices-medical-devices/
    FDA – Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation On 23 April 2020 the EU Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) …

EU GMP Guide Part 1 GMP for Medicinal Products

    https://www.gmp-compliance.org/guidelines/gmp-guideline/eu-gmp-guide-part-1-gmp-for-medicinal-products
    GMP Guidelines Guidelines Detail The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order …

Medical Devices; Current Good Manufacturing Practice …

    https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation
    The FDA is revising the current good manufacturing practice (CGMP) requirements for medical devices and incorporating them into a quality system regulation.

What about GMP/GxP for Medical Devices? - LinkedIn

    https://www.linkedin.com/pulse/what-gmpgxp-medical-devices-lars-eric-ellow
    In the European regulatory environment for Medical Devices, those abbreviations are not so commonly used. The Medical Device industry in the US on the …

GMP for Medical Devices - Live Online Training - ECA Academy

    https://www.gmp-compliance.org/training/gmp-course-conference/gmp-for-medical-devices?file=files/eca/userFiles/seminarpdf/ECA-GMP-Medical-Devices-2022.pdf
    Since 1996, the requirements for the development, the manufacture and the distribution of medical devices in the USA have been laid down in the revised cGMP regulations for …

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 quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP …



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