The new article highlights the aspects related to the requirements applicable to the entities providing medical maintenance services, and also the services in the sphere of technical consultation.
The Saudi Food and Drug Administration (SFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the requirements for licensing of medical devices establishments. The document describes in detail the licensing requirements applicable for various types of entities involved in operations with medical devices. In particular, the guidance provides additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered by medical device establishments in order to ensure compliance with the respective regulations. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers the aspects related to the existing regulatory requirements for medical device manufacturers, importers, and distributors, and also entities providing various services including, inter alia, medical maintenance.
Medical Maintenance: Specific Requirements
First of all, the document outlines specific requirements to be applied with respect to entities providing medical maintenance services. According to the guidance, these requirements include, inter alia, the following ones:
- Employing the necessary staff of engineers and medical maintenance technicians having the necessary qualification and skills. Moreover, the staff should undergo the appropriate training to be conducted by the representatives of the medical device manufacturer responsible for the products to be maintained in order to ensure the staff is well familiar with the devices in question.
- Possess the testing equipment necessary to examine medical device functions. This includes the equipment used for calibration or assessment of the actual safety and performance. The authority additionally emphasizes that such equipment should comply with the requirements set forth by Royal Decree No. (M/51) dated 13/11/1434 AH, as well as regulations associated thereto.
- When applying for the license – provide the authority with organizational structure, a list of technical and administrative staff, a certified copy of their qualifications, training courses, and their job descriptions.
Medical Maintenance: Obligations
Apart from the specific requirements, the document also outlines the obligations medical maintenance services providers should fulfill in order to meet the corresponding requirements they are subject to. According to the guidance, the main obligations include:
- Developing and implementing an efficient maintenance management system, as well as an inventory management system for collecting, storing, organizing, analyzing, and recording data of the medical device in addition to the necessary spare parts. An entity undertaking such an activity should also have a list of suppliers approved by the initial medical device manufacturer to supply spare parts.
- Ensuring the requested spare parts are provided immediately without undue delay unless such delays are justified.
- Strictly following the maintenance instructions communicated by the medical device manufacturer with respect to the maintenance and calibration of a medical device. Should such instructions be unavailable, the appropriate SFDA-approved technical specifications should be followed.
- Having proper storage space for all the items used, including medical devices, other products, and components. Such a space should meet the storage requirements provided by the medical device manufacturer.
- Providing a designated and equipped place for the medical device’s maintenance.
- Using only the test equipment which is duly calibrated by its manufacturer or another entity accredited to conduct calibration of such equipment, with the latter being conducted in accordance with the respective regulatory requirements as described herein above.
- Ensuring compliance with maintenance requirements contained in post-marketing control requirements for medical devices, which are published on SFDA’s website.
- Implementing and following the appropriate documented work procedures and policies.
Technical Consultation: Specific Requirements
The scope of the guidance also covers the aspects related to the technical consultation services and regulatory requirements associated thereto. These requirements include inter alia, the following ones:
- Employing a full-time manager holding a (minimum) bachelor’s degree in the relevant field;
- Submitting key information including the organizational structure, information about the staff and their qualification, as well as about the training the staff has completed;
- Appointing a qualified technical officer for each of the activities undertaken (a bachelor’s degree at minimum is a must);
- Proving a copy of Saudi Commission for Health Specialists certificates for the establishment’s employees;
- Developing and implementing a quality management system ensuring that work procedures and methods used for keeping technical reports related to customers are approved.
Technical Maintenance: Obligations
The document also describes in detail specific obligations to be fulfilled by the entities providing technical consulting services. According to the guidance, such entities should:
- Keep confidential all the information they have access to in the course of their operations, abstaining from revealing any information even after their license has expired;
- Having the necessary knowledge and experience in the relevant sphere, as well as following the principles of independence, impartiality, and integrity, ensuring that there is no conflict of interest in the provided services in case there is more than one activity at the establishment, and ensuring the independence of the technical staff participating in the consultations from any activity of supplying or distributing products in the same field of consultations;
- Ensuring that the services provided are approved by technical staff and respective offices;
- Developing a training plan to develop establishment’s employees in the licensed fields, and committing to provide technical staff with training courses.
In summary, the present SFDA guidance describes in detail the specific requirements applicable to the establishments providing medical maintenance and technical consultancy services. The document also highlights the key points related to the obligations these parties should fulfill.
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