The article provides a general overview of the classification framework for medical devices.
Table of content
The Saudi Food and Drug Authority, a country’s regulatory agency in the field of healthcare products, has published a guidance document dedicated to classification rules and requirements to be followed to ensure the proper regulatory approach is applied.
The scope of the guidance covers, inter alia, the aspects related to the classification of medical devices intended to be marketed and used in the country.
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 legislation.
Regulatory Background
The present guidance document issued by the SFDA is intended to provide a clear and accurate classification of various products subject to regulation under the applicable legislation.
The document aims to categorize products into specific groups each subject to distinct regulatory standards and processes. The scope of the guidance covers a wide variety of products.
For instance, the section “Animal General Care Products” focuses on grooming products intended for animals, such as soaps, shampoos, and products for tooth and ear care.
These products are primarily for cosmetic purposes, including cleaning, beautifying, or deodorizing animals.
The SFDA requires a clearance process for these items unless they contain medicinal ingredients. In such cases, they are classified as veterinary drugs due to their therapeutic properties.
Medical Device Classification: Key Points
The guidance also pays special attention to the regulatory status of products considered medical devices.
In particular, the document clarifies what constitutes a medical device, including instruments, apparatus, implements, machines, or related articles intended for specific medical use.
This section is vitally important for outlining the criteria for a product to be classified as a medical device and guides the process for obtaining marketing authorization for these devices, as detailed in the MDS-REQ1 document.
In-vitro diagnostic Medical Devices (IVDs)
IVDs are defined as products used for providing medical or diagnostic information through the examination of specimens from the human body.
This includes clinical diagnostics reagents, blood glucose meters, and their accessories. The document outlines the regulatory guidelines specific to IVDs and their accessories.
Laboratory Products for Non-Medical Purposes
The relevant part of the document addresses products intended for general laboratory use but not for medical or diagnostic purposes. These products are not regulated as IVDs.
However, if used in medical field institutions, they may require a Medical Device Importation License. This distinction is crucial for laboratory equipment and products.
Chemicals Used with/as Medical Devices
The document also discusses the regulatory considerations for chemicals used in the fabrication of medical devices or as part of a medical device.
This includes substances used in prostheses fabrication, calibration gases, and cleaning chemicals for medical devices, all subject to SFDA regulations.
In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) Products
A separate section classifies products used in IVF and ART as medical devices.
It covers products that modify and support physiological processes, including IVF workstations, pipettes, cryoprotecting solutions, and devices incorporating human blood derivatives or medicinal products.
Wound Management Products
Products that act physically for wound management, such as non-medicated dressings, honey wound dressing gels, and silicone sheets for scar treatment, are also classified as medical devices.
The document emphasizes the distinction between physical action and pharmacological means in this classification.
Skin Peeling Products
The classification of skin peeling products is based on their mode of action, depth of peeling, concentration, and pH.
The document differentiates between products used for physical acne treatment, classified as medical devices, and those for chemical peeling, classified based on specific characteristics.
Medical Radioactive and Imaging Materials
This section covers materials that emit ionized radiation used for medical diagnosis and treatment.
It includes imaging products like X-rays, MRIs, and diagnostic radioactive materials, outlining their regulatory requirements.
In addition to the above, the document provides details on the regulatory status of non-radioactive materials used to enhance contrast in medical imaging techniques.
In particular, it is explicitly stated that these materials also require a medical importation license.
Conclusion
In summary, the present SFDA guidance provides a detailed overview of the applicable classification rules related to medical devices, highlighting the key points to be taken into consideration by medical device manufacturers and other parties interested in placing their products on the country’s market.
The document outlines the main categories of products and explains the specifics of the relevant regulatory framework.
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