الدخول من خلال النفاذ الوطني الموحد
الغرض من هذه الوثيقة تحديد وتوضيح متطلبات الحصول على إذن بتسويق الأجهزة والمستلزمات الطبية (MDMA) وذلك بغرض تداولها (توفيره مجانا أو بمقابل سواء كان للتوزيع أو للاستخدام) بالمملكة، بالإضافة إلى قواعد تصنيف خطورة الأجهزة والمستلزمات الطبية.
تنطبق هذه الوثيقة على مصانع الأجهزة والمستلزمات الطبية المراد تداولها في المملكة وممثليهم المعتمدين.
أصدرت الهيئة هذه الوثيقة استناداً إلى الآتي:
عام
يجب أن يقوم مصنع الجهاز أو المستلزم الطبي بالآتي:
تقديم الطلب
6) تقارير وخطة رقابة ما بعد التسويق.
ويحق للهيئة طلب جميع "المستندات الفنية" إذا دعت الحاجة حتى بعد الحصول على الإذن بالتسويق ويجب توفيرها خلال (10) أيام من طلبها.
ملاحظات:
المتطلبات الموضحة في الملاحق متجانسة مع المتطلبات الرقابية الدولية
3. Manufacturers shall establish, implement, document and maintain a risk management system. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:
4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
5. In eliminating or reducing risks related to use error, the manufacturer shall:
14.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
16.4. Ionizing radiation
20.5. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.
The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.
22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to:
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:
The label shall bear all of the following particulars:
a) The name or trade name of the device, and Arabic name as it is pronounced in English for devices for use by lay persons;
b) The details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
c) The name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
d) Where applicable, an indication that the device contains or incorporates:
e) Contains substances which are carcinogenic, mutagenic or toxic to reproduction or substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health in a concentration above 0,1 % weight by weight (w/w) shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging
f) The UDI carrier.
g) The lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;
h) An unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
i) Where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;
j) An indication of any special storage and/or handling condition that applies;
k) If the device is supplied sterile, an indication of its sterile state and the sterilisation method;
l) Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;
m) If the device is intended for single use, an indication of that fact.
n) If the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
o) If the device is custom-made, the words 'custom-made device';
p) An indication that the device is a medical device. If the device is intended for clinical investigation only, the words 'exclusively for clinical investigation';
q) In the case of 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, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;
r) For active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
s) If the device is intended for non-clinical research, presentation, demonstration, teaching or testing purposes only, an indication of that fact.
The following particulars shall appear on the sterile packaging:
The instructions for use shall contain all of the following particulars:
a) The particulars referred to in points (a), (c), (d), (e), (j), (k), (m) and (q) of Essential Principle (23.2);
b) The device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;
c) Where applicable, a specification of the clinical benefits to be expected.
d) Where applicable, links to the summary of safety and clinical performance referred to in Annex (9);
e) The performance characteristics of the device;
f) Where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;
g) any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;
h) Specifications the user requires to use the device appropriately, e.g. If the device has a measuring function, the degree of accuracy claimed for it;
i) Details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;
j) Any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons;
k) The information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
l) If the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
m) If the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;
n) If the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation information shall be provided to identify when the device shall no longer be reused, e.g. Signs of material degradation or the maximum number of allowable reuses;
o) An indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the essential principals of safety and performance;
p) If the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Essential Principle (23.1) no instructions for use are required, this information shall be made available to the user upon request;
q) For devices intended for use together with other devices and/or general purpose equipment:
r) If the device emits radiation for medical purposes:
s) Information that allows the user and/or patient to be informed of any warnings, precautions, contraindications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate:
t) In the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contraindications, undesirable side-effects and risks relating to overdose;
u) In the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
v) Warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:
w) For devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;
x) For devices to be treated as medical devices but which are not medical devices, that are listed in table (1) of
Annex (5), information regarding the absence of a clinical benefit and the risks related to use of the device;
y) Date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use;
z) A notice to the user and/or patient that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the Saudi Food and Drug Authority;
aa) Information to be supplied to the patient with an implanted device in accordance with Annex (8).
bb) For devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
cc) For devices for use by lay persons, contacts information for the canter(s) within the KSA providing technical assistance for users.
4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in General Requirements are fulfilled.
Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.
Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the processing, preservation, testing and handling of tissues, cells and substances of such origin and control procedures shall be carried out so as to provide safety for user or other person.
In particular, safety with regard to microbial and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This might not apply to certain devices if the activity of the microbial and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device.
13.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
15.2. When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall as far as possible be:
17.6. Where the electrical medical device is intended to be connected to an alternating current (AC) power supply, the device shall be:
18.3. Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated.
Any guards or other means included with the device to provide protection, in particular against moving parts, shall be secure and shall not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer.
18.7. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.
19.2. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as to:
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:
The name of devices for self-testing shall not reflect an intended purpose other than that specified by the manufacturer.
a) The name or trade name of the device, and Arabic name as it is pronounced in English for devices intended for self-testing;
b) The details strictly necessary for the user to uniquely identify the device;
c) The device's intended purpose:
d) An indication that the device is an in vitro diagnostic medical device, or, if the device is a 'device for performance study', an indication of that fact;
e) The intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare professionals);
f) The test principle;
g) A description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only);
h) A description of the reagents and any limitation upon their use (e.g. suitable for a dedicated instrument only) and the composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement;
i) A list of materials provided and a list of special materials required but not provided;
j) For devices intended for use in combination with or installed with or connected to other devices and/or general purpose equipment:
k) An indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions which apply;
l) In-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant;
m) If the device is supplied as sterile, an indication of its sterile state, the sterilization method and instructions in the event of the sterile packaging being damaged before use;
n) Information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. That information shall cover, where appropriate:
o) Any warnings and/or precautions related to potentially infectious material that is included in the device;
p) Where relevant, requirements for special facilities, such as a clean room environment, or special training, such as on radiation safety, or particular qualifications of the intended user;
q) Conditions for collection, handling, and preparation of the specimen;
r) Details of any preparatory treatment or handling of the device before it is ready for use, such as sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer;
s) The information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
t) Where applicable, recommendations for quality control procedures;
u) The metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure;
v) Assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure;
w) Analytical performance characteristics, such as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and measurement range, (information needed for the control of known relevant interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use of available reference measurement procedures and materials by the user;
x) Clinical performance characteristics as defined in Essential Principle (9.1) of this annex;
y) The mathematical approach upon which the calculation of the analytical result is made;
z) Where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value;
aa) Where relevant, reference intervals in normal and affected populations;
bb) Information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of the device;
cc) Warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and the consumables used with it, if any. This information shall cover, where appropriate:
dd) The name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business at which he can be contacted and its location be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance;
ee) Date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use, with a clear indication of the introduced modifications;
ff) A notice to the user that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the Saudi Food and Drug Authority;
gg) Where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the instructions for use requirements contained in this Essential Principle and with the requirements of Medical Devices Law;
hh) For devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorized access, necessary to run the software as intended.
The technical documentation shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include in particular the below elements:
1) Device Description and Specification, Including Variants and Accessories
This section defines the device and any accessories. The following points shall be documented and shall include information relating to the variants and accessories covered by the technical documentation:
2) Information to be provided by the Manufacturer
Information provided by the manufacturer conveys information to the user or clinician and is a key part of the technical documentation. The Technical Documentation shall include a full set of labels for the device and packaging which includes the instructions for use (IFU) and any promotional material as applicable. Information provided by the manufacturer shall fulfill the Essential Principles of Safety and Performance requirements set out in Annex (1).
Specific considerations shall be considered for:
3) Design and Manufacturing Information
This section provides details on the device design and how it is manufactured. This section shall include:
4) Essential Principles of Safety and Performance
This section within the technical documentation is intended to demonstrate how the manufacturer has met the essential principles of safety and performance set out in Annex (1), taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The Essential Principles checklists shall be used to demonstrate this and should form this section of the technical documentation. The demonstration of conformity shall also include:
5) Benefit-Risk Analysis and Risk Management
This section of the technical documentation documents the benefit to risk assessment and demonstrates that the device is considered safe. This section may directly refer to the device risk assessment or the clinical evaluation (or both). A risk/benefit statement should appear in these documents and this may be repeated here, or reference made to it.
a) Risk management should be documented and should contain as a minimum:
Evidence of these documents shall appear within the technical documentation. The Risk Management Plan, Analysis and Report could be combined into one document or separate documents, as long as each part meets the requirements for planning, analysis and reporting.
Risks should be controlled to ensure they are 'as low as possible' and the risk analysis criteria should be either referenced or explained.
b) The risk management procedure should ensure required elements are addressed:
Persons performing risk management tasks shall have the knowledge and experience appropriate to the tasks assigned to them. SFDA.MD/ ISO 14971 provides direction and further information for conducting Risk Management activities.
c) Risk management plan shall include:
d) Risk management analysis shall include:
e) Risk Management report shall include:
6) Product Verification and Validation
This section of the technical documentation lists the methods and standards used to verify and validate the product. The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of Medical Devices Law and in particular the applicable Essential Principles of Safety and Performance.
Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service.
7) Post Market Surveillance Plan
The post market surveillance plan section describes within the technical documentation what systems are in place to ensure appropriate post market surveillance data is collected. This section shall include:
8) Periodic Safety Update Report and Post Market Surveillance Report
a) Post-market surveillance report
Manufacturers of class A devices shall prepare a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the SFDA upon request.
b) Periodic safety update report
Manufacturers of class B, class C and class D devices shall prepare a periodic safety update report (PSUR) for each device and where relevant for each category or group of devices summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
Manufacturers of class C and D devices shall update the PSUR at least annually.
Manufacturers of class B devices shall update the PSUR when necessary and at least every two years.
1) Device Description and Specification, Including Variants and Accessories:
a) Product or trade name and a general description of the device including its intended purpose and intended users (list all products or variants that are covered by the technical file, including any accessories).
b) Clear identification of device by product code, model number, catalogue number or other unambiguous means.
c) The intended purpose of the device which may include information on:
d) The description of the principle of the assay method or the principles of operation of the instrument.
e) The rationale for the qualification of the product as a device;
f) The risk class of the device and the justification for the classification rule(s) applied in accordance with Annex (5).
g) The description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers;
and where applicable
h) The description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use;
i) For instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays;
j) For automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation;
k) A description of any software to be used with the device;
l) A description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
m) A description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device.
n) Reference to previous and similar generations of the device
2) Information to be Supplied by The Manufacturer:
Information provided by the manufacturer conveys information to the user or clinician and is a key part of the technical documentation. The Technical Documentation shall include a full set of labels for the device and packaging which includes the instructions for use (IFU) and any promotional material as applicable. Information provided by the manufacturer shall fulfill the essential principles of safety and performance requirements set out in Annex (2).
This section within the technical documentation is intended to demonstrate how the manufacturer has met the essential principles of safety and performance set out in Annex (2), taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The Essential Principles checklists shall be used to demonstrate this and should form this section of the technical documentation. The demonstration of conformity shall also include:
5) Benfit-Risk Analysis and Risk Management
Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service. This includes:
7) Post-market surveillance plan
1. Medical Devices & Devices without a Medical Purpose
1.1.1 Duration of Use
1.1.2 Invasive and Active Devices
by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.
1.1.2 Others
1.2 Implementing Rules
Table 1 - Groups of products without an intended medical purpose
2.3 Classification Rules
2.3.1 Non-Invasive Devices
Rule 1
All non-invasive devices are classified as class A, unless one of the rules set out hereinafter applies.
Rule 2
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:
In all other cases, such devices are classified as class A.
Rule 3
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.
Rule 4
All non-invasive devices which come into contact with injured skin or mucous membrane are classified as:
This rule applies also to the invasive devices that come into contact with injured mucous membrane.
2.3.2 Invasive devices
Rule 5
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:
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 classified as class B.
Rule 6
All surgically invasive devices intended for transient use are classified as class B unless they:
Rule 7
All surgically invasive devices intended for short-term use are classified as class B unless they:
Rule 8
All implantable devices and long-term surgically invasive devices are classified as class C unless they:
2.3.3 Active Devices
Rule 9
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 intended for diagnosis and monitoring are classified as class B:
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 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:
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.
Rule 12
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 are classified as class A.
2.3.4 Special Rules
Rule 14
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product including a medicinal product derived from human blood or human plasma and that has an action ancillary to that of the devices, are classified as class D.
Rule 15
All 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.
Rule 16
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
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class B.
Rule 18
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are nonviable or rendered non-viable, are classified as class D, unless such devices are manufactured utilising 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 in Class A.
Rule 19
All devices incorporating or consisting of nanomaterial are classified as:
Rule 20
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 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:
Rule 22
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.
2. In Vitro Diagnostic Medical Devices
2.1 Definitions Specific to the Classification Rules
2.2 Implementing Rules
Devices intended to be used for the following purposes are classified as class D:
Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers:
in which case they are classified as class D.
Devices are classified as class C if they are intended:
The following devices are classified as class A:
Devices not covered by the above-mentioned classification rules are classified as class B.
Devices which are controls without a quantitative or qualitative assigned value are classified as class B.
Part (A): Clinical Evaluation
1. To plan, continuously conduct and document a clinical evaluation, manufacturers shall:
2. The clinical evaluation shall be thorough and objective, and take into account both favorable and unfavorable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.
3. A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:
4. The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the essential principals of safety and performance and shall be part of the technical documentation for the device in question. Both favorable and unfavorable data considered in the clinical evaluation shall be included in the technical documentation.
Part (B): Post-Market Clinical Follow-Up
5. PMCF shall be understood to be a continuous process that updates the clinical evaluation referred Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is SFDA approved and is placed on the market or put into service within its intended purpose, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence
6. PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
7. The manufacturer shall analyze the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation.
8. The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation Part A of this Annex and in the risk management referred to in Section 3 of Annex (1). If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
2. Clinical Performance Studies
3. Post-market Performance Follow-Up
a) confirming the safety and performance of the device throughout its expected lifetime,
b) identifying previously unknown risks or limits to performance and contra-indications,
c) identifying and analysing emergent risks on the basis of factual evidence,
d) ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio,
e) identifying possible systematic misuse.
f) the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data;
g) the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance studies;
h) the specific objectives to be addressed by the PMPF;
i) an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art;
j) reference to any relevant recognized standards when used by the manufacturer, and relevant guidance on PMPF;
k) a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer.
1. The manufacturer of an implantable device shall provide together with the device the following:
The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information and shall be stated in Arabic and English language. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a) of the first subparagraph.
In addition, the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device.
2. Health institutions shall make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
3. The following implants shall be exempted from the obligations laid down in this Annex: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The Saudi Food and Drug Authority, when necessary, will amend this list by adding other types of implants to it or by removing implants therefrom.
Summary of safety and clinical performance
1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.
The summary of safety and clinical performance shall be written in a way that is clear to the intended user.
The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the SFDA. The manufacturer shall mention on the label or instructions for use where the summary is available.
2. The summary of safety and clinical performance shall include at least the following aspects:
3. The SFDA may set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance.
If the answer is yes, please check the appropriate box
‹ The device provides considerable clinical advantage over an existing SFDA approved technology.
‹ The device provides considerable clinical advantage over an existing approved alternative treatment.
‹ There are no SFDA approved alternative device technologies nor treatments available to patients.
Attestations:
I confirm that the information given in this form is true, complete and accurate.
Intended Use
Which may include:
Device Description
Device Characteristics
(address all that apply)
Level of Evidence
(identify and discuss)
Pre-clinical data:
Clinical Investigation documentation and Investigator's Brochure:
Clinical Evaluation/Literature Review
يمكن الرجوع إلى صفحة التعاميم بالموقع الالكتروني للهيئة العامة للغذاء والدواء على الرابط التالي:
https://www.sfda.gov.sa/ar/circulars?keys=&date%5Bmin%5D=&date%5Bmax%5D=&tags=3
SFDA will issue MDMA certificate in both Arabic and English containing the following:
( يطبع على الورق الرسمي الخاص بالمصنع )
اضغط هنا لنسخة قابلة للطباعة والتعديل
We ……… <mmanufacture name>, <manufacture address> and <Establishment Medical Device National Registry (MDNR) number> hereby declare that the below mentioned medical device(s) conform to the “Medical Device Law" issued by the Royal Decree No. (M/54) dated 6/7/1442 H, and its Requition issued by the Board of Directors of the Food and Drug Authority (…..) dated (……). And willing to make the evidence of the fulfillment of these requirements available to the SFDA, upon request.
نقر نحن .................. <اسم المصنع> و<عنوان المصنع> و<رقم السجل الوطني للمنشأة> (عندما ينطبق ذلك) ......................... أن الأجهزة والمستلزمات الطبية المذكورة أدناه تتوافق مع "نظام الأجهزة والمستلزمات الطبية" الصادر بالمرسوم الملكي رقم (م/54) وتاريخ 6/7/1442هـ.، ولائحته التنفيذية الصادرة بقرار مجلس إدارة الهيئة العامة للغذاء والدواء رقم (.....) وتاريخ ..................
وعلى استعداد لتقديم ما يثبت ذلك للهيئة عند الطلب.
Generic Name:
Trade/Brand Name:
Model Name/Number:
Intended Purpose:
Risk Class:
Classification Rule Number:
Manufacturing Site:
Applied Standards:
الاسم العام/الجنيس:
الاسم التجاري/العلامة التجارية:
رقم/اسم الطراز:
الغرض من الاستخدام:
درجة الخطورة:
رقم قاعدة تصنيف الخطورة:
موقع التصنيع:
المواصفات المطبقة:
Authorized Signatory
Name:
Position:
Date:
Signature:
المخول بالتوقيع
الاسم:
المنصب:
التاريخ:
التوقيع:
Medical devices may be bundled/grouped within one application based on the criteria of each category below:
Note: If the device has accessories, they may be included with the device within the same MDMA application, unless they are marketed separately.
A maximum of 5 TFs of Medical devices may be bundled/grouped within one application only if they have:
Note: TOTAL NUMBER of medical device that are grouped/bundled within a single application shall NOT EXCEED 50 items.
Medical devices compromising a system may be bundled/grouped within a maximum of 5 TFs only if they:
Medical devices compromising a procedure pack may be bundled/grouped within a maximum of 5 TF only if they:
Submission requirements:
2. IVD Medical Devices
Examples on IVD products with same intended use/purpose:
Examples on IVD products with different intended use/purpose:
Examples of lab specialty:
means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device.
means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
means a device which is essential for the safe and effective use of a corresponding medicinal product to:
is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
means any adverse event that led to any of the following:
(a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring,
(b) death,
(c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following:
(d) fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
means any incident that directly or indirectly led, might have led or might lead to any of the following:
5.0
− تعديلات عامة لتتوافق مع نظام الأجهزة والمستلزمات الطبية ولائحته التنفيذية
− تعديل في متطلبات الأجهزة والمستلزمات الطبية منخفضة الخطورة
− تعديلها من "الدليل الإرشادي لمتطلبات قيد وإذن تسويق الأجهزة والمنتجات الطبية (MDS-G5) إلى "متطلبات الإذن بتسويق الأجهزة والمستلزمات الطبية (MDS-REQ1)"
− إضافة "الاشتراطات والمتطلبات الوطنية للأجهزة والمنتجات الطبية" كالآتي:
· الملحق (1) في الفقرات (7) و(15.2) و(16.5) و(18.9) و(18.10) و(22.1) و(a-23.1) و(f-23.1) و(i-23.1) و(a-23.2) و(a-23.4) و(s-4-23.4) و(cc-23.4)
· الملحق (2) في الفقرات (7) و(14.2) و(17.6) و(17.7) و(19.1) و(a-20.1) و(f-20.1) و(k-20.1) و(a-20.2) و(a-20.4.1) و(h-20.4.2)
· الملحق (3) في الفقرة (d) و(e)
· الملحق (4) في الفقرة (c) و(d)
− إضافة الملاحق من (7) إلى (12)
آخر تحديث : 13 أبريل 2022
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