The Saudi Arabian Medical device registration and approval is governed by the Saudi Food and Drug Authority, also known as the SFDA. The procedure for the introduction of a medical device in the Saudi Arabian market is called Medical Device Marketing Authorization (MDMA).
SFDA has published a guidance document, MDS-REQ-001, on Requirements for Medical Device Marketing Authorization. This guidance provides detailed information on the authorization process.
Saudi Arabian Medical Device Classification
SFDA classifies medical devices into four classes: Class A, B, C & D. Medical device classification is done as per Annex 5 of MDS-REQ-001. The medical devices are classified based on 22 rules, while the in-vitro diagnostic devices are classified based on seven rules.
Any foreign manufacturer willing to market their product in the Kingdom of Saudi Arabia (KSA) must appoint a Saudi Arabia Authorized Representative (AR). This AR will carry out all the registration formalities on behalf of the legal manufacturer.
The AR must possess an Authorized Representative License to conduct the registration activities effectively.
What is GHAD System?
The SFDA has switched to an electronic system for document submission, called GHAD System. Local and Foreign manufacturers, via an AR, should submit their application electronically in the GHAD System.
The manufacturer shall prepare a Technical Documentation, comply with and confirm the Essential Principles of Safety and Performance and maintain an effective Quality Management System (QMS).
4 Components of Saudi Arabian Technical Documentation
Other essential components of Saudi Arabian Technical Documentation will include:
1. Device Description & Specification
2. Labels and IFUs
3. Risk Management File
4. Post Market Surveillance documents
SFDA can request more information if needed which should be provided to them within ten days of request.
In addition to the above-mentioned documents, clinical evaluation is another important documentation in the Technical File. Adequate clinical evaluation studies should be carried out to prove the safety and efficacy of the medical device.
Performance evaluation studies should be carried out demonstrating scientific validity, and clinical and analytical performance. A strong clinical evaluation report, plan, and post-market clinical follow-up should support the technical file.
Post Market Surveillance
Post Market Surveillance Report is required to be submitted by manufacturers of Class A devices. This report should be generated when necessary or when requested by the SFDA. Manufacturers of Class B, C and D devices should generate a Periodic Safety Update Report (PSUR).
A PSUR should be generated annually for Class C and D devices and once every two years for Class B devices. Class D and Implantable devices should produce Summary of Safety and Clinical Performance documentation.
The SFDA also accepts electronic Instructions for Use (e-IFU). The manufacturers should provide adequate risk assessment documentation related to the e-IFU. The risk assessment should be updated in conjunction with the post-marketing activities.
For devices with a fixed expiry date, the e-IFU should be maintained for at least two years after the end of the expiry date of the last produced device. For devices with no expiry, the e-IFU should be maintained for 15 years after the previous device has been manufactured.
About OMC Medical
OMC Medical is primarily based in the UK with offices around the globe offering regulatory support to medical device manufacturers; Offering assistance starting from medical device design requirements in accordance to the relevant applicable standards, obtain relevant MoH certification or listings, establishing your devices in a new market, keep product licenses up to date until the product is End of Service (EOS).
In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace.
One country that has embraced this transformative trend is Saudi Arabia, where the beauty industry has flourished, reflecting the changing cultural landscape. However, with growth comes the need for regulations to ensure consumer safety and product quality.
Legal Framework for Saudi Arabia Cosmetic Regulations
Saudi Arabia has established a robust legal framework to govern the cosmetics industry, ensuring that products meet stringent safety, efficacy, and quality standards. The Saudi Food and Drug Authority (SFDA) plays a pivotal role in regulating cosmetics and ensuring manufacturers follow the Cosmetic Regulations in Saudi Arabia.
The SFDA operates in accordance with international best practices, harmonizing its regulations with global standards to facilitate the import and sale of cosmetics in Saudi Arabia.
The Law of Cosmetic Products promulgated by Royal Decree number M/49 on 18/6/1436 AH is the Cosmetic Regulation followed in Saudi Arabia.
Registration Process for Cosmetic Regulations in Saudi Arabia
One of the primary requirements for cosmetic products entering the Saudi market is registration with the SFDA. Manufacturers and distributors must submit detailed documentation about their products, including information on ingredients, formulations, and safety assessments.
This rigorous registration process guarantees that cosmetics comply with Saudi regulations and do not pose any health risks to consumers.
Notifying is listing cosmetic products in the SFDA records via the Cosmetic Notification system (eCosma) and does not mean SFDA has evaluated the product safety.
Notifying aims to create a comprehensive database of cosmetic products manufactured locally or imported by recording them in SFDA records, and the notifier (responsible person) shall comply with the validity of the information entered and the safety of the products.
Product Testing and Safety
Cosmetic products must undergo rigorous safety assessments to meet the SFDA’s standards. This includes testing for microbiological contamination, stability, and compliance with permissible limits of certain ingredients.
Manufacturers are responsible for providing evidence of product safety during the registration or notification process.
Halal Certification
Given the cultural and religious context of Saudi Arabia, the concept of Halal (permissible in Islam) is of utmost importance. Like other consumer goods, cosmetic products may undergo Halal certification to ensure they adhere to Islamic principles.
While Halal certification is not mandatory, many manufacturers seek it as a mark of authenticity and to appeal to the sensibilities of the Saudi consumer base.
Ingredient Restrictions
Saudi Arabia imposes strict regulations on the ingredients used in cosmetics. Certain substances are prohibited or restricted due to their potential harm to consumers. The SFDA maintains a list of restricted ingredients, and compliance is mandatory for all cosmetic products sold in the country.
This includes a comprehensive ban on ingredients that are considered hazardous or pose a risk to human health. The notifier (responsible person) must ensure the integrity of the entered data and the product’s safety.
Note that the Authority published a list of the banned products and restricted use in the cosmetic products in addition to a list of preservatives and colouring items allowed in the Cosmetic Products Website in accordance to article four of the Implementing Regulation of the Cosmetic Products Law.
Labelling Requirements for Cosmetic Regulations in Saudi Arabia
Precise and accurate labelling is crucial for consumer safety and informed choices. The SFDA mandates that all cosmetic products bear labels in Arabic, providing essential information such as product name, ingredients, instructions for use, and contact details of the manufacturer or distributor. Compliance with these labelling requirements is essential for market access and consumer trust.
When submitting cosmetic product notifications, a clear image (one or more) of the product from all sides that shows its information and substitutions in a visible and readable way is required. The image shall include the internal and external product label and its internal brochure, if any. The images can be presented in one of the following forms: PNG, JPG, TIFF, or PDF.
The cosmetic product label shall confirm with the Cosmetic Products Legislation and the Standard of Safety Requirements for Cosmetic Products and personal care No. GSO1943/20016.
The product label must contain its barcode and shall be entered into the cosmetic notification system, taking into account the product’s size and colour.
Post-Market Surveillance
To ensure ongoing consumer safety, the SFDA conducts post-market surveillance to monitor the safety and quality of cosmetic products already in circulation.
This involves regular inspections, product sampling, and analysis to identify potential risks or violations. Manufacturers and distributors must cooperate fully with the SFDA during these surveillance activities to maintain compliance.
Conclusion
Saudi Arabia’s cosmetics industry thrives, driven by a dynamic consumer base seeking high-quality, safe, and culturally appropriate products. The regulatory framework established by the SFDA plays a pivotal role in maintaining the integrity of the market and ensuring that cosmetics meet the highest standards.
As the industry continues to evolve, staying abreast of the regulatory landscape is imperative for businesses seeking success in Saudi Arabia’s beauty sector.
Beauty truly knows no borders, and by understanding and adhering to the regulations, companies can contribute to the flourishing beauty industry in the Kingdom while prioritizing consumer well-being.
The medical devices regulatory framework has a classification system for medical devices as per the classification rules specified in “MDS-REQ1: Requirements for Medical Device Marketing Authorization”.
The manufacturer is responsible for determining the classification of a device using a set of classification rules based on the:
manufacturer’s intended use of the device
level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm)
degree of invasiveness in the human body
duration of use
Classification Level
Level of risk
Class A
Low
Class A – supplied sterile
Low-medium
Class A – incorporating a measuring function
Low-medium
Class A – reusable surgical instruments
Low-medium
Class B
Low-medium
Class C
Medium-high
Class D
High
The manufacturer is responsible for determining the class of the IVD by:
Using the classification rules for IVD medical devices
Considering both the:
Intended use of the device
Level of risk to the patient and public of an incorrect result.
Classification
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
SFDA Medical Devices Implementation Rules
The intended use of the devices shall determine how the classification standards are applied. The class of a device is identified by its intended use or purpose, not by its specific technological features unless those features directly relate to the purpose.
The class of the device is determined by the intended purpose provided by the manufacturer, not the class assigned to other comparable devices.
SFDA Devices must be “intended specifically” for the use indicated in a specific classification regulation, and this must be made evident by the manufacturer in the device’s accompanying documentation.
Otherwise, it is assumed that it is being used for its intended purpose, which is primarily recognised and applied in general medical practice.
If the device in question is meant to be used with another device, then each device will be subject to its own classification requirements. A product’s and a medical device’s accessories must be categorised separately from the product they are used with.
Based on their intended use, systems are classified as a whole. Instead of classifying the system as a whole, the classification of a specific device may be determined by referring to the most basic configuration that may still be regarded as a device in and of itself based on its proper functioning features.
Instead of classifying the system as a whole, a device that is a component of a system may be classified as a device in and of itself. However, in such cases, the device must be cleared separately as a distinct device.
Similarly, integrated devices made of components with various functional goals may be examined independently in relation to each of these parts.
Rule 1 – Devices that either do not come in direct contact with the patient or contact intact skin only General explanation of the rule.
All non-invasive devices are classified as class A, unless one of the rules set out hereinafter applies. This rule generally applies to devices that come into contact only with intact skin or that do not touch the patient.
By storing, channeling, or treating blood, other body fluids, liquids that are returned to or injected into the body, or by producing energy supplied to the body, several non-invasive devices are indirectly in contact with the body and can affect internal physiological processes.
Due to the risks associated with such an indirect influence on the body, these must be excepted from applying this Rule and dealt with under a different rule.
Rule 2: Channeling or Storing for Eventual Administration
These types of devices must be considered separately from the non-contact devices of rule 1 because they may be indirectly invasive. They distribute or store materials that will later be injected into the body.
These devices are typically used for transfusion, infusion, extracorporeal circulation, and the supply of oxygen and anaesthetic gases. Devices covered by this criterion can occasionally be very basic gravity-activated delivery devices.
All non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are classified as class B:
If they may be connected to a class B, class C or class D active device
If they are intended for use for channeling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues,
Except for blood bags; blood bags are classified as class C.
In all other cases, such devices are classified as class A.
Rule 3 – Devices that modify the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body
These types of devices must be considered separately from the non-contact devices of Rule 1 because they are indirectly invasive. They alter the materials that will ultimately be infused into the body.
This regulation primarily applies to the more complex components of extracorporeal circulation systems, dialysis systems, and autotransfusion systems, as well as devices for extracorporeal treatment of bodily fluids that may or may not be immediately reintroduced into the body, including situations where the patient is not in a closed loop with the device.
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body are classified as class C,
Unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which case they are classified as class B
All non-invasive devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body are classified as class D.
Eg. Haemodialysis concentrates, Device removing specific blood cells (e.g. activated) by specific binding to a matrix, Removal of carbon dioxide from the blood and/or adding oxygen.
Rule 4 – Devices that come into contact with injured skin or mucous membrane General explanation of the rule
This guideline covers wound dressings in general, regardless of the depth of the wound. According to Rule 14, dressings containing drugs that serve as an add-on to the dressing fall under Class D.
Devices made of other materials that are ingested by or locally distributed in the human body are covered by Rule 21.
All non-invasive devices which come into contact with injured skin or mucous membrane & invasive devices that come into contact with injured mucous membrane are classified as:
Class A if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates
Class C if they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent
Class B if they are principally intended to manage the micro-environment of injured skin or mucous membrane
Class B in all other cases
Rule 5 – Devices invasive with respect to body orifices
It is necessary to distinguish between invasiveness that enters by a cut in the body surfaces and invasiveness that affects bodily orifices (such as the ear, mouth, nose, eye, anus, urethra, and vagina) (surgical invasiveness).
Another distinction between invasiveness and regard to the less sensitive anterior sections of the ear, mouth, and nose, as well as the various anatomical sites that can be reached through natural body orifices, must be made for short-term use.
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class A active device are classified as:
Class A if they are intended for transient use
Class B if they are intended for short-term use
Except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class A
Class C if they are intended for long-term use
Except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they fall under class B
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class B, class C or class D active device, are falling under class B.
Rule 6 – Surgically invasive devices intended for transient use (<60 min)
This rule largely applies to three types of devices: those that are used to construct a conduit through the skin (such as needles and cannulae), those used in surgery (such as scalpels and saws), and different catheters and suckers.
All surgically invasive devices intended for transient use are classified as class B unless they:
Are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class D
Are reusable surgical instruments, in which case they are classified as class A
Are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class D
Are intended to supply energy in the form of ionising radiation in which case they are classified as class C
Have a biological effect or are wholly or mainly absorbed9 in which case they are classified as class C
Are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class C
Rule 7 – Surgically invasive devices intended for short-term use (> 60 min <30 days)
The majority of these are infusion equipment (cannulae, needles), surgical or post-operative care devices (such as clamps, drains), and various kinds of catheters.
All surgically invasive devices intended for short-term use are classified as class B unless they:
Are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class D
Are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class D
Are intended to supply energy in the form of ionizing radiation in which case they are classified as class C
Have a biological effect or are wholly or mainly absorbed in which case they are classified as class D
Are intended to undergo chemical change in the body in which case they are classified as class C, except if the devices are placed in the teeth
Are intended to administer medicines, in which case they are classified as class C
They are mostly employed in soft tissue implants, such those used in plastic surgery, as well as implants for the orthopaedic, dental, ophthalmology, and cardiovascular sectors.
All implantable devices and long-term surgically invasive devices are classified as class C unless they:
Are intended to be placed in the teeth, or on a prepared tooth structure, in which case they are classified as class B
Are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class D
Have a biological effect or are wholly or mainly absorbed, in which case they are classified as class D
Are intended to undergo chemical change in the body in which case they are classified as class D, except if the devices are placed in the teeth
Are intended to administer medicinal products, in which case they are classified as class D
Are active implantable devices or their accessories, in which cases they are classified as class D;
Are breast implants or surgical meshes, in which cases they are classified as class D
Are total or partial joint replacements, in which case they are classified as class D, with the exception of ancillary components such as screws, wedges, plates and instruments
Are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class D with the exception of components such as screws, wedges, plates and instruments.
Rule 9 – Active therapeutic devices intended to administer or exchange energy, as well as active devices intended to control/monitor/directly influence certain devices
This regulation applies to a wide range of device types, including: electrical surgical tools like surgical generators and lasers, stimulation devices, devices intended to emit ionising radiation, therapeutic purposes, including devices that control or monitor such devices or that directly influence their performance and devices intended to control, monitor, or directly influence the performance of active implantable devices.
All active therapeutic devices intended to administer or exchange energy are classified as class B
Unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class C.
All active devices intended to control or monitor the performance of active therapeutic class C devices, or intended directly to influence the performance of such devices are classified as class C.
All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class C.
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class D.
Rule 10 – Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology
This regulation applies to a wide variety of devices used in many different sectors to record physiological signals, including specifically therapeutic and diagnostic radiology.
Remember that Rule 17 applies to equipment used to record diagnostic X-ray pictures. Rules 8 or 9 apply to equipment particularly designed to track active implanted devices.
Active devices intended for diagnosis and monitoring are classified as class B:
If they are intended to supply energy which will be absorbed by the human body,
Except for devices intended to illuminate the patient’s body, in the visible spectrum, or near infra-red spectrum, in which case they are classified as class A
If they are intended to image in vivo distribution of radiopharmaceuticals
If they are intended to allow direct diagnosis or monitoring of vital physiological processes
Unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class C.
Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class C.
Rule 11 – Software intended to provide information to inform decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes
For standalone software, abide by the following:
It is not considered an accessory if software or equipment is added to a device that does not clearly permit the use of the device(s) in accordance with that purpose or specifically or directly supports the medical functioning of the device(s) in terms of that purpose.
In general, software used in conjunction with medical equipment that only capture, save, or show data would not be regarded as devices.
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class B, except if such decisions have an impact that may cause:
Death or an irreversible deterioration of a person’s state of health, in which case it is in class D
A serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class C
Software intended to monitor physiological processes is classified as class B
Except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class C
All other software is classified as class A
E.g., Medical Device Software to diagnose sleep apnoea, SFDA Medical Device Software to select dose of cytostatic drugs, Medical Device Software monitoring of heart rate data intended as an aid.
Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body
This rule is primarily meant to address anaesthesia equipment and drug delivery systems. Rule 20 is applicable if the device is designed to deliver drugs via the pulmonary route.
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class B
Unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class C.
Rule 13 – All other active devices
This is a fallback rule to cover all active devices not covered by the previous rules. All other active devices are classified as class A.
E.g., Devices intended in general for external patient support (e.g. electric hospital beds, patient hoists, electric wheelchairs, dental patient chairs), Dental curing lights.
Rule 14 – Devices incorporating, as an integral part, an ancillary medicinal product, and medicinal products derived from human blood or blood plasma
The goal of this regulation is to apply to combination devices that include a medical component built in to support the operation of the device.
This criterion does not, however, apply to devices that contain substances that, in other contexts, may be regarded as medicinal, but which are included in the device solely to maintain specific properties of the device and which are not likely to effect on the body.
The device’s principal purpose is independent of the medication’s pharmacological, metabolic, or immunological effects. If the latter is true, the product is not covered by this advice because it is a medicinal product rather than a device.
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in “SFDA Products Classification Guidance”, including a medicinal product derived from human blood or human plasma, as defined in “SFDA Products Classification Guidance”, and that has an action ancillary to that of the devices, are classified as class D.
E.g. Antibiotic bone cements, Contraceptive intrauterine devices (IUDs) containing medicinal copper or silver, Drug eluting stents.
Rule 15 – Devices used for contraception or prevention of sexually transmitted diseases
This regulation encompasses invasive, implanted, and non-invasive medical devices for contraception or the prevention of STDs; it is not just applicable to physical barrier-based contraceptives.
The rule applies to contraceptive methods and methods for preventing the spread of STDs; non-invasive, temporary, or short-term use devices fall under class C, whereas implantable or long-term use devices go under class D.
However, these intended uses deal with unique instances of human vulnerability that fall outside the scope of the traditional duration, invasiveness, and organic function requirements.
Although this rule applies to two quite different device applications, some devices, like condoms, may serve both purposes. This rule also applies to devices that are intended to prevent HIV from being transmitted sexually.
All SFDA devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class C
Unless they are implantable or long term invasive devices, in which case they are classified as class D
This regulation covers liquids for cleaning, disinfecting, or hydrating contact lenses as well as other materials and tools used primarily in a medical setting to clean medical devices.
This regulation is meant to apply to a variety of items used exclusively with contact lenses, such as solutions for storing lenses and solutions for supporting lenses worn on the ocular surface.
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are classified as class C.
All devices intended specifically to be used for disinfecting or sterilising medical devices are classified as class B,
Unless they are disinfecting solutions or washer disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class C.
This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.
Rule 17 – SFDA Devices to record X-ray diagnostic images
This regulation covers standalone X-ray detectors and sensors used as recording devices in a variety of medical imaging processes, known as modalities, each of which employs a unique set of methods and technologies.
It covers both active and inactive devices that are used to record X-ray images of the human body for diagnostic purposes. The rule’s objective is to largely apply to digital devices and related recording media, but it does not apply to media (including digital media) used for later image processing and archiving.
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class B.
E.g., X-ray films, Photostimulable phosphor plates, Digital x-ray detectors for recording images
Rule 18 – Devices manufactured utilizing tissue or cells of human or animal origin or their derivatives
SFDA Devices that contain or are made of animal tissues that have been rendered non-viable or derivatives from such tissues that have also been rendered non-viable, i.e. where there is no longer a capacity for cellular metabolic activity, are covered by this rule.
The scope of this guidance does not apply to devices that incorporate live animal tissues or any derivatives made from human tissues.
Certain devices may be made using industrial raw materials that have trace amounts of tallow or tallow derivatives. For the purposes of this rule, such chemicals are not regarded as being derived from animal tissues, hence it does not apply.
According to Rule 1, Class A devices are those made of non-viable animal tissue that only make contact with intact skin.
All devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class D
Unless such devices are manufactured utilizing tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only. In which case they are class A.
E.g., Collagen dermal fillers, Bone graft substitutes, Leather components of orthopaedic appliances
Rule 19 – Devices incorporating or consisting of nanomaterial
There are many different ways that nanoparticles can be used in medical equipment. It is important to think about any possible nanomaterial exposure.
It is also known that even when a medical device does not contain nanomaterials, normal wear and tear can nevertheless produce particles that are nanometers in size.
Medical equipment can expose people to nanoparticles in a number of ways. When nanoparticles are embedded in or fastened to the surface of the material of the medical device, degradation or wear processes may also expose users to these materials.
Class D if they present a high or medium potential for internal exposure
Class C if they present a low potential for internal exposure
Class B if they present a negligible potential for internal exposure
E.g., Bone fillers with nanomaterials in their formulation, Bone fixation screws/plates with a strongly bound nano-coating high potential, and Dental filling materials.
Rule 20 – Invasive devices, intended to administer medicinal products by inhalation
Nebulizers, pressurised metered-dose inhalers (pMDI), and dry powder inhalers are the three platforms on which aerosol medicinal chemicals are delivered by devices (DPIs).
The amount of drug that will arrive at the desired site of deposition has a major role in an aerosol therapy’s success.
Rule 20 is specifically intended to cover medical devices where the impact of the device on the efficacy and safety of the delivered medicinal product is crucial, in contrast to other rules covering devices that administer medicinal products.
The restriction also applies to drug delivery products meant to treat illnesses with a high risk of death.
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are classified as class B
Unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life-threatening conditions, in which case they are classified as class C.
Rule 21 – Devices composed of substances that are introduced via a body orifice or applied to the skin
SFDA Medical gadgets for self-care are made of various substances or combinations of chemicals. Among them are items like dentifrices for sensitive teeth, verruca and wart removers, gels for vaginal discomfort, other personal lubricants, cough syrups, products used to reduce bloating, denture cleansers and adhesives, creams to treat or prevent minor skin irritations, or anti-flatulence products.
Nasal solutions are primarily used for sufferers, often infants, with cold symptoms and blocked noses.
They are categorised as devices because their method of action relies on chemico-physical processes rather than pharmacological, immunological, or metabolic mechanisms.
These processes include local pH changes, molecular sequestration, and the development of physical barriers.
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:
Class D if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose
Class D if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body
Class B if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities
Class C in all other cases.
E.g., Salt water used e.g. as nose or throat sprays, Oral cough treatments achieving their intended purpose in the oral cavity as far as the pharynx, Eye drops for hydration.
Rule 22 – Active therapeutic devices, with an incorporated diagnostic function
This rule also applies to PHYSIOLOGIC CLOSED-LOOP CONTROLLERS in ME EQUIPMENT and ME SYSTEMS, which are anticipated to offer an effective method to enhance PATIENT safety and lower healthcare expenses.
Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class D.
E.g., Automated external defibrillators including their pads/electrodes, Closed-loop systems for deep brain stimulation (DBS) treatment of various neurological conditions.
