The new article addresses the aspects related to device-specific requirements, and also describes the procedures to be followed when applying for marketing approval.
The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of medical devices and other healthcare products, has published a guidance document dedicated to the Point of Care (POC) medical devices manufacturing. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers in order to ensure compliance thereto. 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. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The guidance contains, inter alia, a table that outlines requirements and procedures to be applied with respect to different types of medical devices. According to the document, device-specific rules include, inter alia, the following ones:
- Medical Device Production System (MDPS) should be based on medical-grade raw materials, validated by their supplier. If a device or any part thereof is being manufactured via 3D printing, the appropriate approval (Medical Device Marketing Authorization – MDMA) will be required for the software used to manage the printing process. The manufacturer shall also maintain the MDPS file covering the key aspects including the ones related to raw materials, software, equipment, final product, intended use, and users.
- In-House IVD [in vitro diagnostic device] include the products developed from scratch, developed and modified from a public source, or modifications to the ones that are commercially supplied. The concept applies to manufacturing or modifying in vitro diagnostic test devices by healthcare institutions for their own needs. According to the document, such processes should be duly documented, and the respective records should be provided to the authority upon request.
- Implantable Medical Devices and Implant Card. As explained by the authority, one copy of an implant card should be provided to the patient, while another one should be stored by the party responsible for a medical device being implanted. The device itself should be accompanied by the following information:
- Details needed to identify the device, including its name and the patient identifier;
- Warning, precautions, and other important information to be considered with respect to the measures to be taken in order to ensure the safety and proper performance of the device when used for its intended purpose;
- Details about the projected lifetime and patient follow-up;
- Additional information reasonably required by device users to ensure the safety of patients for which the device is used, including the details about materials and substances used.
Processes and Procedures
The document further describes the general process and procedures to be followed by the parties involved in order to ensure compliance with the applicable regulatory requirements when placing their product on the market.
Under the general rule, the set of documents required (depending on the type of device subject to review) should be submitted to the authority via email for subsequent review. Should the authority identify that some of the documents or information are missing, the applicant will be notified within 5 days. In case the applicant fails to provide the documentation requested within 60 days, the application will be considered “Void”. Once a complete set of documents is received, the authority will commence a substantial review which takes up to 30 days. Depending on the results of the review, the authority will take one of the following decisions:
- “No Objection Letter” will be issued if any and all applicable requirements are duly satisfied; or
- “Objection Letter” will be issued if the respective requirements are not fully satisfied. In this case, the authority will justify the decision taken and communicate this information to the applicant.
The authority also mentions that in case the scope of POC is changed or broadened, or an extra manufacturing site is added, approval from the authority will be required. Apart from this, medical device manufacturers should duly notify the authority in case the production is ceased.
In accordance with the respective legislation, the authority is entitled to conduct inspections of POC sites in order to ensure continuous compliance with the applicable regulatory requirements without notifying them about the inspection in advance.
Information and Documentation
The guidance also outlines the scope of information and documentation to be submitted to the authority by the party responsible for a medical device. According to the guidance, it includes:
- Application Form for Point of Care (POC) Medical Device Manufacturing. An example of the said form is provided in annexes to the present guidance.
- Medical Device Marketing Authorization (MDMA), compliant with the respective regulatory requirements outlined in a separate guidance document issued by the SFDA. As it was mentioned before, it will also be required for the software used for printing medical devices.
According to the example of an application form, the scope of information to be provided by the manufacturer includes the following:
- Basic information about the healthcare facility, including its name and address, as well as the name and contact details of a responsible person.
- Information about the medical device / IVD test, including its description and an indication of the intended use, as well as the proper justification for medical device manufacturing / IVD test development or modification at the Point-of-Care.
- A declaration whereby medical device manufacturer declares that:
- POC Manufactured medical devices are for the healthcare facility’s own use and not to be transferred to other facilities;
- SFDA has the right to monitor the compliance in the POC site at any time without prior notification;
- The information provided in this application is true and accurate.
In summary, the present guidance highlights important aspects related to POC medical devices (including IVD tests) manufacturers should consider in order to ensure compliance with the applicable regulatory requirements. The document describes in detail the application process and also outlines the scope of information and documentation the authority expects the applicant to provide.
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