The Ministry of Health of the Republic of Kazakhstan has developed a draft order aimed at further developing the quality control system for medical devices and improving procedures for their market approval.
One of the key solutions will be the introduction of early inspection practices—before the assessment begins. This approach will allow for early assessment of product compliance with established requirements and make processes more consistent and convenient for all participants.
The project also clarifies approaches to classifying medical devices by potential risk levels. This will allow for the development of a more flexible and balanced control system, where requirements are tailored to the specific characteristics of individual products.
Additionally, the document systematizes the list of documents required to pass inspection. Clear and understandable requirements create a comfortable environment for manufacturers and help reduce the administrative burden.
A separate section is devoted to detailing inspection procedures. The new mechanisms are aimed at increasing the transparency of processes and establishing uniform, clear rules of engagement.
The development of a quality management system is also planned, including clarification of requirements for documentation and monitoring of all stages of production and testing. This is in line with modern international approaches and enhances market confidence in the product.
Overall, the proposed changes are aimed at creating a more modern, convenient, and transparent regulatory system that will facilitate the development of the industry and the implementation of innovative medical solutions.
The Document can be found at the link: https://legalacts.egov.kz/npa/view?id=15817186
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
One of the key solutions will be the introduction of early inspection practices—before the assessment begins. This approach will allow for early assessment of product compliance with established requirements and make processes more consistent and convenient for all participants.
The project also clarifies approaches to classifying medical devices by potential risk levels. This will allow for the development of a more flexible and balanced control system, where requirements are tailored to the specific characteristics of individual products.
Additionally, the document systematizes the list of documents required to pass inspection. Clear and understandable requirements create a comfortable environment for manufacturers and help reduce the administrative burden.
A separate section is devoted to detailing inspection procedures. The new mechanisms are aimed at increasing the transparency of processes and establishing uniform, clear rules of engagement.
The development of a quality management system is also planned, including clarification of requirements for documentation and monitoring of all stages of production and testing. This is in line with modern international approaches and enhances market confidence in the product.
Overall, the proposed changes are aimed at creating a more modern, convenient, and transparent regulatory system that will facilitate the development of the industry and the implementation of innovative medical solutions.
The Document can be found at the link: https://legalacts.egov.kz/npa/view?id=15817186
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
