The article provides a general overview of the regulatory framework for medical devices with measuring functions.
Table of content
The Turkish regulating authority in healthcare products has published a guidance document dedicated to testing, control, and calibration activities.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with it.
The authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Regulatory Background
In particular, the present guidance document is intended to describe in detail the procedural and principled approach required to effectively implement medical device testing, control, and calibration activities.
Its creation is based on the need for a standardized methodology that aligns with the regulatory demands outlined in the official documentation. The primary objective is to ensure the safety, and effectiveness of medical devices through a well-structured regulatory framework.
Recommendations provided in the guidance are based on the Presidential Decree and specific regulations. The document also introduces a set of definitions critical to the uniform understanding of regulatory requirements.
These include, but are not limited to, the Responsible Manager Working Certificate, Expert Working Certificate, and the Product Tracking System (ÜTS). Such definitions are crucial for delineating roles, responsibilities, and processes within the regulatory ecosystem.
Application Procedure for Conformity Assessment Bodies
A substantial part of the guide details the application process for organizations seeking authorization to conduct testing, control, and calibration services.
It specifies the electronic submission protocol, document requirements, and the procedural steps for application through ÜTS.
As explained by the authority, such a detailed approach ensures that applicants provide all necessary documentation and adhere to the stipulated criteria, fostering a transparent and efficient authorization process.
Evaluation and Approval Process
Post-application, the guide outlines a comprehensive evaluation process beginning with paying application fees and culminating in an on-site examination.
This segment outlines the criteria for review, the steps for addressing application deficiencies, and the pathway to obtaining Authorization Certificates.
The emphasis is on ensuring that organizations meet the stringent requirements, thereby validating their competence and reliability in conducting testing, control, and calibration activities.
Operational Protocols for Testing, Control, and Calibration
The document also describes the specific procedures for conducting testing, control, and calibration activities.
It delineates the process for creating calibration requests, device selection for testing, and adherence to national and international standards.
The guide explains the need for detailed reporting and submission protocols for test results, ensuring a high level of transparency and accountability in these critical activities.
Audit Mechanisms for Compliance and Quality Assurance
According to the guidance, routine and unscheduled audit mechanisms are implemented to maintain the highest compliance and quality standards.
These audits are vitally crucial for identifying deviations from the set standards, with a straightforward process for organizations to address and rectify identified deficiencies.
It is also important to mention that failure to comply with the relevant regulatory requirements could trigger the administrative sanctions imposed on the responsible party.
Conclusion
In summary, the present document provides detailed and comprehensive step-by-step procedures to be followed by the parties involved when conducting specific regulatory actions through the official portal.
The guidance emphasizes specific aspects to be taken into consideration to ensure completeness and accuracy of the information provided by the responsible parties. Also, it outlines the key points that are vitally important in the context of compliance with the requirements set forth under the existing legal framework.
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