Food and Drug Administration: Standards for grouping medical devices into a single application

In a move aimed at enhancing the efficiency of regulatory procedures and supporting the healthcare sector in the Kingdom, the Saudi Food and Drug Authority (SFDA) a draft of new standards related to the grouping of medical devices and supplies under a single marketing authorization application. These standards have been published on the National Competitiveness Center's "Survey" platform to allow the public and private sectors to provide feedback, as part of the SFDA's efforts to streamline the application process and facilitate licensing procedures in accordance with the updated requirements (MDS-REQ1).

The context of organizational development and its importance

This initiative is part of the Saudi Food and Drug Authority's strategy to keep pace with digital transformation and achieve the goals of Vision 2030 in developing the healthcare sector and facilitating the business environment. Regulating the registration of medical devices is a cornerstone in ensuring the safety and efficacy of products circulating in the Saudi market. By reducing bureaucracy and consolidating similar applications, the Authority aims to minimize the time and effort required by manufacturers and suppliers, which will positively impact the speed with which modern medical technologies are made available to patients and healthcare providers, while maintaining the highest standards of quality and safety.

General requirements for assembling devices

The Authority has established a precise framework for the circumstances under which medical devices may be combined into a single application. The fundamental requirement is that the devices be manufactured by the same legitimate manufacturer , intended for the same medical purpose, and fall under the same risk category. Furthermore, the devices must comply with the GMDN code, if applicable, and share similar physical design, manufacturing materials, and production processes. To ensure compliance, the Authority has set a limit of five technical files per application and a maximum of 50 devices in total.

Examples and practical applications

To clarify, the Authority provided models of devices that can be assembled, such as catheters of different lengths and brands, guide wires of varying flexibility, hearing aids, bone plates, intraocular lenses (IOLs), and implantable defibrillators, provided they share the same purpose and function.

Regulations for surgical, dental, and laboratory instruments

The criteria included detailed specifications for the various categories:

• Surgical and dental instruments: They can be grouped together if they are from the same manufacturer, risk class, and share the same manufacturing materials, while adhering to the maximum limit for files and devices.
• Integrated medical systems: Devices that work together as a single system (such as a hip replacement system or electrosurgical units) may be grouped together, provided the entire system is fully documented in a comprehensive technical file.
• In vitro diagnostic devices (IVDs): Standards have been established for their assembly based on the operating principle (e.g., immunological or genetic testing) and medical purpose, to include categories such as blood typing and tumor markers.

This new regulation is expected to contribute to reducing operating costs for companies and accelerating the product lifecycle from manufacturing to reaching the end user, thus enhancing the attractiveness of the Saudi market as a leading investment destination in the field of medical technologies.