The medical devices and in vitro diagnostics (IVDs) market in Saudi Arabia is tightly regulated to ensure the safety, efficacy, and quality of products used within the healthcare system. The Saudi Food and Drug Authority (SFDA) plays a crucial role in overseeing this market, including the classification and grouping of medical devices and IVDs. Understanding these classifications is essential for manufacturers, importers, and distributors aiming to navigate the regulatory landscape effectively.
What are medical devices under SFDA Regulation in Saudi Arabia (KSA)?
In Saudi Arabia, the definition of a medical device encompasses any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article. The medical devices are characterized by not achieving their primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but they may be assisted in their intended function by such means.
These devices are intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific purposes:
diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;
Investigation, replacement, modification, or support of the anatomy or of a physiological process;
supporting or sustaining life; control of conception;
disinfection of medical devices; and
providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
Medical Devices
Definition of Medical Device Accessories under SFDA Regulations in Saudi Arabia (KSA)
Under the SFDA regulations, an accessory is defined as a product specifically intended by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.
Classification of Medical Devices under SFDA Regulations in Saudi Arabia (KSA)
Medical devices in Saudi Arabia are classified based on their intended use, duration of contact with the body, and the risk they pose to patients and users. The SFDA follows a risk-based classification system similar to international standards, categorizing devices into four main classes:
Risk Class | Level of Risk | |
Class A | Non Sterile, Non-measuring | Low Risk |
Class A | Supplied as Sterile product | Low-Medium Risk |
Class A | with Measuring function | Low-Medium Risk |
Class A | Reusable surgical Instruments | Low-Medium Risk |
Class B | NA | Low-Medium Risk |
Class C | NA | Medium - High Risk |
Class D | NA | High Risk |
Grouping of Medical Devices under SFDA Regulations in Saudi Arabia (KSA)
Medical devices can be grouped for regulatory purposes based on their intended use, technology, and design. This grouping helps streamline the registration process and ensures consistency in regulatory review. The main grouping categories include:
Family of Medical Devices: A group of medical devices that share common features, intended use, and classification. They must be from the same manufacturer and share similar designs and manufacturing processes.
System: A set of medical devices intended to be used together to achieve a common intended purpose. The components may belong to different classes but are evaluated as a single entity.
Procedure Pack: A collection of medical devices packaged together for a specific medical procedure. The pack may include devices from various classes but is reviewed as a single unit.
Family | System | Procedure Pack |
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