What is the GMP standard for medical devices?

2020-08-06T17:36:04+00:00December 27th, 2018|

Good manufacturing practice (GMP) requirements in the medical industry are designed to ensure that medical devices and medical equipment (abbreviated as “AMAR” in Hebrew) are manufactured in accordance with quality system management principles, and include all aspects of production, including starting and raw materials, production facilities, employee training qualification and cleaning procedures.

In Israel, the Ministry of Health perform audits and conducts enforcement procedures.

In the US, GMP requirements for drugs and finished pharmaceuticals are enforced under 21 CFR parts 210-211, and quality system requirements for medical devices are covered by 21 CFR 800, also known as the Quality System Regulations (QSR).

In the EU, GMP requirements for drugs and medicinal products are enforced as part of Directive 93/42/EEC, and quality system requirement for medical devices are described in the Medical Device Directives and the 2017 Medical Device Regulations.

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