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.
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In-Vitro Diagnostic Medical Devices
Classification of IVDs under SFDA Regulations in Saudi Arabia (KSA)
IVDs are classified separately from other medical devices due to their distinct nature and purpose. The SFDA classifies IVDs based on the risk they pose to public health and their impact on individual patient care:
Risk Class | Level of Risk |
Class A | Low Individual Risk and Low Public Health Risk |
Class B | Moderate Individual Risk and/or Low Public Health Risk |
Class C | High Individual Risk and/or Moderate Public Health Risk |
Class D | High Individual Risk and High Public Health Risk |
Accessories for In Vitro Diagnostic Devices under SFDA Regulations in Saudi Arabia (KSA)
For in vitro diagnostic (IVD) medical devices, accessories are articles that are not classified as in vitro diagnostic medical devices themselves but are intended by their manufacturer to be used alongside one or several specific IVD medical devices. Their role is to enable the IVD medical devices to achieve their intended purposes or to directly assist the medical functionality of the IVD devices in terms of their specific purposes.
Grouping of IVDS under SFDA Regulations in Saudi Arabia (KSA)
When submitting an application for In Vitro Diagnostic (IVD) medical devices in Saudi Arabia, a maximum of five Technical Files (TFs) can be included in a single application. The devices included in these TFs must adhere to specific criteria to ensure they are appropriately grouped:
Same Risk Classification: All IVD devices within the application must fall under the same risk classification category.
Same Legal Manufacturer: The devices must be produced by the same legal manufacturer.
Same Intended Use/Same Principle of Operation: The devices should share the same intended use or operate based on the same principle.
Closely Similar Design and Manufacturing Process: The design and manufacturing process of the devices should be closely similar.
Additionally, the total number of IVD medical devices grouped or bundled within a single application must not exceed 50 items.
Examples of IVD Products with the Same Intended Use/Purpose:
Culture Media: Blood agar and MacConkey agar
Susceptibility Tests
Blood Collection Tubes: Examples include tubes with EDTA or heparin
Examples of IVD Products with Different Intended Use/Purpose:
Blood agar and enzyme tests
HIV and ABO grouping tests
Pregnancy kits and Hepatitis virus tests
Registration of medical device and IVD accessories under SFDA Regulations in Saudi Arabia (KSA)
If a medical device or IVD includes accessories, they may be included in the same Medical Device Marketing Authorization (MDMA) application as the main device, provided they are not marketed separately. This streamlined approach facilitates the registration process and ensures that all components essential for the medical device’s intended use are reviewed together.
Navigating the classification and grouping of medical devices and IVDs in Saudi Arabia requires a thorough understanding of the SFDA's regulatory framework. By adhering to these regulations, manufacturers and importers can ensure that their products meet the highest standards of safety and efficacy, ultimately contributing to the advancement of healthcare in the Kingdom. As the Saudi healthcare sector continues to evolve, staying informed about regulatory updates and maintaining compliance will be crucial for success in this growing market.
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