SaMD Registration in SFDA (Software as a Medical Device)

Medical applications (apps) and software used with or without hardware medical devices are well-established in healthcare. They support clinical decision-making and administrative tasks. These are known as Software as a Medical Device (SaMD), which create new regulatory challenges. In response, the Saudi Food and Drug Authority (SFDA) adopted the related guidelines published by the International Medical Device Regulators Forum (IMDRF), ensuring patient safety while encouraging healthcare innovation. The SFDA required SaMD registration approval before marketing.

This article will discuss how SaMD is categorized and registered in SFDA.

Definition

The SaMD term refers to software intended for medical purposes that can function independently without being part of a hardware medical device. SaMD can operate on general-purpose platforms like smartphones, computers, or tablets and may be used on its own or in combination with other medical devices, including hardware medical devices or other SaMD applications.

Key points about SaMD include:

• It includes in-vitro diagnostic (IVD) devices.
• It cannot be defined as such if its sole purpose is to drive a hardware medical device.
• Mobile apps that meet these criteria are considered SaMD.

The medical purposes of SaMD align with the SFDA’s definition of Medical Devices and include software intended for diagnosis, monitoring, treatment, or other medical functions.

SaMD Categorisation

The categorization is essential for determining the appropriate safety and regulatory requirements for SaMD registration.

Factors

The two major factors that guide this categorization are as follows:

Significance of the Provided Information by SaMD

This information influences the SaMD’s role in healthcare decision-making, which can range from immediate clinical action to supporting long-term management.

• To Treat or Diagnose:
  • Treatment/Prevention/Intervention: SaMD provides information that prompts immediate or near-term actions for treating, preventing, or mitigating a condition. It may connect to other medical devices, medicinal products, or therapy means to the human body.
  • Diagnosis/Screening/Detection: SaMD diagnoses or detects conditions using sensors or data from other devices, providing immediate insights into a disease or condition.
• To Drive Clinical Management:
  • Aiding in Treatment: SaMD helps enhance the safe and effective use of medicinal products or medical devices.
  • Aiding in Diagnosis: It analyzes information to help predict risks or support definitive diagnoses.
  • Triage or Early Detection: SaMD assists in identifying early signs of a condition or triaging, guiding further diagnostics or treatment actions.
• To Inform Clinical Management:
  • SaMD provides information that does not trigger immediate action.
  • It may inform clinicians of treatment options, diagnostic possibilities, or preventative measures, helping to aggregate relevant clinical data such as disease progression, drugs, or medical devices.

State of the Healthcare Situation or Condition

• Critical Situation:
  • Involves life-threatening conditions or time-sensitive situations where immediate and accurate intervention is vital to avoid death, long-term disability, or significant health deterioration. Examples include incurable diseases, major therapeutic interventions, or conditions where time is critical.
  • SaMD in these scenarios is typically intended for fragile populations (e.g., paediatrics, high-risk patients) and often requires specialized professionals.
• Serious Situation:
  • Conditions where accurate diagnosis or timely treatment is essential to avoid unnecessary interventions or irreversible consequences but are not immediately life-threatening. These include moderate progression diseases (e.g., cancers that can be treated if detected in time), where timely interventions can prevent long-term damage.
  • SaMD may be used by specialized professionals or lay users, though non-specialized users should have adequate support to avoid risks.
• Non-Serious Situation:
  • Involves non-urgent conditions where accurate diagnosis and treatment are important but not critical for long-term outcomes.
  • Examples include chronic diseases with slow progression (e.g., manageable minor illnesses).
  • These conditions usually require minor interventions and may be used by either specialized or lay users, with the ability to detect errors.

When these key factors are combined with the manufacturer’s description of the SaMD, specifying its critical features necessary for healthcare decisions, they can be used to categorize the SaMD. This systematic approach is referred to as the SaMD Definition Statement.

Principles

The following is a necessary set of principles based on the SaMD Definition Statement and are essential to categorize SaMD appropriately:

• The categorization depends on the manufacturer’s accurate and complete SaMD definition statement.
• Categories are established based on the importance of the information provided by the SaMD and the specific healthcare conditions it addresses.
• SaMD is classified into four categories (I, II, III, IV) based on its potential impact on patient or public health. Category IV has the highest impact and Category I has the lowest.
• If the SaMD applies to various healthcare situations, it is categorized at the highest category based on its definition statement.
• Any changes made by the manufacturer to the SaMD’s definition statement throughout its lifecycle should prompt a re-evaluation of its categorization based on the updated information.
• An SaMD retains its own category according to its definition statement even when it interacts with additional SaMD, medical devices or is used as part of a larger system.

Categories

Determining Criteria for SaMD Categories:

SaMD Registration

SaMDs in Saudi Arabia require SFDA registration. The process is similar to that for typical medical devices and requires a similar technical file. However, some parts do not apply to SaMDs. The registration should be through the Medical Device Marketing Authorisation (MDMA) application. The owner of the software marketing rights can apply to SFDA through a Saudi-authorised representative.

Registration Support

If you’re an international company that requires approval to market a medical app or SaMD, you may request this service from our team, which will support your project and have you ready to market through a local distributor or promote your online subscriptions.