Questions and Answers
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.
A medical device/accessory may be marketed only after having been approved as a medical device and registered in the Medical Devices Department of the Ministry of Health in accordance with the conditions of registration.
The purpose of medical device registration is to ensure the safety and effectiveness of medical devices and their accessories that are used in the health systems in the State of Israel. Medical device/accessory certification is for finished products only.
Importation of medical equipment into Israel through customs requires Ministry of Health approval via a free import order. There are two types of certification issued by the Ministry of Health Medical Device and Medical Equipment Division: The first type is periodic import clearance, which is divided into two groups: medical equipment registered in the medical device register, and unregistered products. The second type is a one-time import permit to bring medical supplies into Israel. This approval does not allow the importer to bring additional shipments of this product to Israel, nor does it mean that the products approved for import are registered in the medical equipment register.
The Medical Device and Medical Equipment Division of the Israel Ministry of Health may issue a “free sale permit” or “certificate of free sale” (CFS or FSC) to exporters, which facilitates approval by overseas health authorities of medical products and equipment that are registered and authorized for marketing and sale in Israel.
Fake or counterfeit medical equipment is equipment that has not been approved by the Ministry of Health and is branded by its manufacturer as original equipment that is recognized in the market, but actually is not produced by the original manufacturer.
The development of medical equipment can be done in two ways: The first is the fast track route, which refers to the process of developing medical equipment that is already on the market, i.e., upgrading existing medical equipment. The second way is to develop new medical equipment from beginning to end. As with the development of any new product, even within the framework of medical device development, the process begins with the development of a prototype. Subsequently, various experiments and tests are performed to check the safety of the various devices and to obtain preliminary approval from the Ministry of Health to proceed. After this step, clinical research should be performed to evaluate the safety and efficacy of the medical devices in a representative group of patients. Upon completion of the clinical study and analysis of its results, applications may be made to obtain required regulatory approvals and, upon approval, the device marketing process may begin.
A quality system in the medical field is designed to ensure the safety, efficacy and quality of a consumer medical product and has the aim of protecting public and patient health. Quality managers in development and/or at manufacturing companies must have the appropriate education and experience, while being familiar with specific, relevant standards and regulations.
To the article Quality Assurance Systems and CAPA
Validation is documented proof which provides a high degree of assurance that a system, process, equipment, manufacturing process, and/or medical device software will be properly installed, operated and processed, is robust, consistent, and delivers a result that meets the predefined qualifications and quality requirements. The purpose of validation is to ensure that the medical equipment meets all quality, efficacy and safety requirements defined for the final product, both in worst-case situations and during all stages of production, while adhering to a controlled and documented process.
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