The new article describes in detail the regulatory approach to be followed concerning the manufacturing process, post-market surveillance, and other aspects.
Table of content
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in healthcare products, has published a guidance document dedicated to developing in-house in vitro diagnostic (IVD) medical devices healthcare institutions may create to meet their internal needs.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by healthcare institutions and other parties involved in operations with medical devices to ensure compliance with it, as well as the continuous safety of patients.
The authority also 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.
Manufacturing Process
The scope of the guidance covers, among other things, the aspects related to the manufacturing process.
As explained by the authority, manufacturing in-house IVDs encompasses the design and assembly of these devices, potentially utilizing both internally sourced components and commercial kits modified for specific medical purposes.
In this respect, the document outlines the critical aspects of managing manufacturing risks, emphasizing the necessity for adherence to well-established principles to ensure product safety and efficacy.
Purchasing and Resource Allocation
As further elaborated by the SFDA, successful in-house IVD manufacturing necessitates meticulous planning, resource scheduling, and strategic purchasing. The focus is on material consistency, highlighting the need for documented procedures to verify that all sourced products meet strict specifications.
This ensures materials do not adversely affect assay performance.
Key considerations include supplier selection, especially for critical quality components like antibodies, and the stringent control of subcontracted services, including software development, to maintain device safety.
Manufacturing Environment
Detailing the controlled conditions under which in-house IVDs are produced, the relevant section of the guidance elaborates on the comprehensive planning required from design to validation and eventual release.
It additionally emphasizes the importance of creating and maintaining detailed records for each production batch, ensuring traceability and compliance with designated performance standards.
Conditions critical to production, such as environmental cleanliness and equipment calibration, are also addressed by the authority, underlining the necessity for systematic monitoring and control.
Competence and Staff Expertise
The authority also mentions the vital role of experienced personnel in developing and validating new IVD tests.
It calls attention to the necessity for a skilled workforce capable of addressing complex diagnostic challenges, highlighting the importance of maintaining records of staff expertise and ensuring the presence of qualified supervisors and trainers for effective problem-solving.
Verification Before Routine Use
By the applicable regulatory requirements, before deploying an in-house IVD, laboratories must verify its suitability for the intended clinical setting.
This involves conducting comprehensive technical tests to affirm compliance with regulatory safety, performance, and quality standards.
The data gathered from these tests must be thoroughly reviewed and approved to confirm the device’s readiness for routine application.
Labeling
The document also emphasizes the importance of accurate labeling, detailing the need for clear indications of the device’s IVD status, lot or batch number, expiration date, contents, and storage instructions. Sterilization methods, if applicable, should be prominently displayed to ensure user safety and device sterility.
Overall, accurate labeling is crucial to ensure the critical information about the device is communicated to its potential users.
Packaging and Transport
Even though in-house assays may fall outside specific regulatory transport requirements, the general principles of safe storage and transport are also covered by the scope of the present guidance.
Laboratories are advised to consider risks associated with storage conditions and to design validated packaging solutions that prevent reagent deterioration during transit.
Post Market Surveillance
The guidance also provides an overview of proactive and reactive post-market surveillance (PMS) strategies. It describes the necessity for continuously evaluating the device’s performance and suitability through direct observation and feedback from clinical use.
This ensures that any adverse events or performance issues are promptly addressed, maintaining the device’s effectiveness and safety.
Conclusion
In summary, the present guidance document issued by the SFDA provides a comprehensive overview of the critical elements involved in the manufacture and management of in-house IVDs.
The document highlights the key points to ensure compliance with the respective regulatory requirements, the proper performance of the products and the safety of patients.
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