sfda_gov_sa · regulation · processed · 102 chunks
الهييه العامه للدفاع والمواع
Saudi Food & Drug Authority
SFDA
MDS – REQ 1
Requirements for Medical Devices Marketing Authorization
Version Number: 6.0
Version Date: 19/12/2021
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Table of Content
Introduction 3
Purpose 3
Scope 3
Background 3
Requirements 4
Annexes 6
Annex (1) Essential Principles of Safety and Performance for Medical Devices other than In-Vitro Medical Device 7
Annex (2): Essential Principles of Safety and Performance for In-Vitro Medical Devices 29
Annex (3) Medical Device Technical Documentation 50
Annex (4) IVD Technical Documentation 59
Annex (5) Risk Classification Rules for Medical Devices 69
Annex (6) Clinical Evaluation and Post-Market Clinical Follow-Up 81
Annex (7): Performance Evaluation, Performance Studies and Post-Market Performance Follow-Up 84
Annex (8) Implant Card and Information to be Supplied to the Patient with an Implanted Device 91
Annex (9) Summary of Safety and Clinical Performance 92
Annex (10): Electronic Instructions for Use (e-IFU) 93
Annex (11): Innovative Medical Device Summary Form 95
Annex (12) Fees, Application Review Time and Validity 97
Annex (13): MDMA Certificate Content 98
Annex (14) Declaration of Conformity (DOC) 99
Annex (15): Bundling Criteria 100
Annex (16): Definitions & Abbreviations 104
Annex (17): List of Changes on the Previous Version 109
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Introduction
Purpose
The purpose of this document is to specify and clarify the requirements obtaining medical devices marketing authorization (MDMA) for the purpose of making available in return for payment or free of charge of a medical device, with a view to distribution and/or use within the KSA, In addition to risk classification rules for medical devices.
Scope
This document applies to manufacturers of medical devices for the purpose of making available with the KSA, and their authorized representatives.
Background
SFDA has issued this document in reference to the following:
- Article Eight, Nine and Ten of the "Medical Devices Law" issued by the Royal Decree No. (M/54) dated 6/7/1442 H
- "Implementing Regulation of Medical Devices Law" issued by Saudi Food and Drug Authority Board of Directors decree No. (3-29-1443) dated 19/2/1443H
- Following SFDA/MDS announcements:
○ Announcement number (2/13/MDS-AN012) regarding marketing authorization renew & update fees and review times, and Announcement number (MDS-01-01-21) dated 13/1/2021 supplementary to the announcement number (2/13/MDS-AN012)
○ Announcement (8) 8/2019 regarding Updated timeframe for deleting medical device marketing authorization (MDMA) applications
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Requirements
<table><tr><td rowspan="3">General</td><td>1</td><td>Medical device may be made available in return for payment or free of charge, with a view to distribution and/or use within the KSA only if it is registered at SFDA and obtaining medical devices marketing authorization (MDMA).</td></tr><tr><td>2</td><td>Medical device shall comply with the “Essential Principles of Safety and Performance” specified in Annex (1) and Annex (2).</td></tr><tr><td>3</td><td>Medical device manufacture shall: - Prepare, hold and update the “Medical Device Technical Documentation” and/or “IVD Technical Documentation” that confirm to “Essential Principles of Safety and Performance” specified in Annex (3) and Annex (4) - Establish, document and maintain an effective quality management system (QMS) according to the international ISO standard (ISO 13485:2016) or any identical adopted standard for the same issue/version.</td></tr><tr><td>Submitting to SFDA</td><td>4</td><td>- Application shall be submitted by a local manufacturer, an overseas manufacturer or the AR of the overseas manufacturer if overseas manufacturer wishes, after they obtain the following: • Local Manufactures: License of medical devices manufacture through the "GHAD System - Licensing Services" • Authorized Representative: License of authorized representative through the "GHAD System - Licensing Services"</td></tr><tr><td></td><td></td><td>- Applicant shall submit the “Application Form for Medical Devices Marketing Authorization” electronically via “GHAD System - Marketing Authorization Services” and provide required documents specified in the application form. - In regard of low-risk medical devices (except IVDs, sterile, having measuring function, reusable surgical instruments, and novel), the following shall be submitted in accordance to “Technical Documentation” in Annex (3): 1. Device Description and Specification 2. Information to be Provided by The Manufacturer 3. Essential Principles Checklist 4. Evidence of Compliance with the Applicable Essential Principles</td></tr></table>
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<table><tr><td></td><td></td><td>5. Risk Management File6. Post-Market Surveillance Plan and ReportSFDA has the right to request all “Technical Documentation” if necessary, even after obtaining the MDMA, and they shall be provided within (10) days of its requestNotes1. Manufacture shall classify the medical device according to the “Risk Classification Rules for Medical Devices” specified in Annex (5).2. Innovative medical devices are exempted from some of the requirements specified in Annex (3) and Annex (4) when verifying the eligibility of the exception after submitting “Innovative Medical Device Summary Form” in Annex (11).- Applicant shall pay fees specified in Annex (12).- Medical devices may be bundled/grouped within one MDMA application based on the criteria mentioned in Annex (15).- Once satisfied, SFDA will issue MDMA including the information specified in Annex (13).</td></tr><tr><td>Post submitting</td><td>5</td><td>SFDA shall be informed, via the electronic system, within (10) days of the occurrence any significant change to the relevant information or (30) non-significant changes. For more information, see guidance on variations.6</td></tr><tr><td></td><td></td><td>The MDMA certificate shall be renewed before its expiration date, and the updated documents, if necessary, shall be submitted through the electronic system, and a renewal request can be submitted 90 days before its expiry date.</td></tr></table>
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Annexes
The requirements stated in the annexes are harmonized with international regulatory requirements
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Annex (1) Essential Principles of Safety and Performance for Medical Devices other than In-Vitro Medical Device
<table><tr><td colspan="2">General Requirements</td></tr><tr><td>1.</td><td>Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.</td></tr><tr><td>2.</td><td>The requirement in this annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.</td></tr><tr><td>3.</td><td>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:a) Establish and document a risk management plan for each device;b) Identify and analyse the known and foreseeable hazards associated with each device;c) Estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;d) Eliminate or control the risks referred to in point (c) in accordance with the requirements of Essential Principle (4);e) Evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; andf) Based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Essential Principle (4).</td></tr></table>
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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:
a) Eliminate or reduce risks as far as possible through safe design and manufacture;
b) Where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
c) Provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users. Manufacturers shall inform users of any residual risks.
5. In eliminating or reducing risks related to use error, the manufacturer shall:
a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
6. The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. The environmental and/or conditions of use that may be encountered within the KSA shall be considered and addressed.
8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.
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<table><tr><td>9.</td><td>For the devices which do not have medical intended purpose but shall be treated as medical devices, that are listed in table (1) of Annex (5), the general safety requirements set out in Essential Principle (1) and Essential Principle (8) shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.</td></tr><tr><td colspan="2">Requirements Regarding Design and Manufacture</td></tr><tr><td>10.</td><td>Chemical, physical and biological properties</td></tr><tr><td>10.1.</td><td>Devices shall be designed and manufactured in such a way as to ensure that the general characteristics and performance requirements are fulfilled. Particular attention shall be paid to:a) The choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;b) The compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;c) The compatibility between the different parts of a device which consists of more than one implantable part;d) The impact of processes on material properties;e) Where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;f) The mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance;g) Surface properties; andh) The confirmation that the device meets any defined chemical and/or physical specifications.</td></tr><tr><td>10.2.</td><td>Devices shall be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to patients, taking account of the intended purpose of the devices. Particular attention shall be paid to tissues exposed those contaminants and residues and to the duration and frequency of exposure.</td></tr></table>
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<table><tr><td>10.3. The devices shall be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use.</td></tr><tr><td>10.4. Substances</td></tr><tr><td>10.4.1. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues that may be released from the device.</td></tr><tr><td>10.4.2. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product/drug as defined in the relevant legislation and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance shall be verified, taking account of the intended purpose of the device.</td></tr><tr><td>10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.</td></tr><tr><td>10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.</td></tr><tr><td>11. Infection and microbial contamination</td></tr><tr><td>11.1. The devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible and appropriate the risk of infection to patients, users and, where applicable, other persons. The design shall:a) Reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,b) Allow easy and safe handling,c) Reduce as far as possible and appropriate any microbial leakage from the device and/or microbial exposure during use, andd) Prevent microbial contamination of the device or its content such as specimen or fluids.</td></tr><tr><td>11.2. Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilization</td></tr></table>
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<table><tr><td>11.3.</td><td>Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.</td></tr><tr><td>11.4.</td><td>Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.</td></tr><tr><td>11.5.</td><td>Devices labelled as sterile shall be processed, manufactured, packaged and, sterilized by means of appropriate, validated methods.</td></tr><tr><td>11.6.</td><td>Devices intended to be sterilized shall be manufactured and packaged in appropriate and controlled conditions and facilities.</td></tr><tr><td>11.7.</td><td>Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilization indicated by the manufacturer.</td></tr><tr><td>11.8.</td><td>The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.</td></tr><tr><td>12.</td><td>Devices which, if used separately, would be considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.</td></tr><tr><td>12.1.</td><td>In the case of devices which incorporate, as an integral part, a substance which, if used separately, would be considered to be a medicinal product, shall be verified by reference to SFDA requirements for medicinal products.</td></tr><tr><td>12.2.</td><td>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 shall comply with the state of the art for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for the occurrence of adverse events.</td></tr><tr><td>13.</td><td>Devices incorporating materials of biological origin</td></tr></table>
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13.1. For devices manufactured utilizing derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable the following shall apply:
a) Donation, procurement and testing of the tissues and cells shall be done in accordance with the state of the art;
b) Processing, preservation and any other handling of those tissues and cells or their derivatives shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process;
c) The traceability system for those devices shall be complementary and compatible with state of the art traceability and data protection.
13.2. For devices manufactured utilizing tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable the following shall apply:
a) Where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, shall originate from animals that have been subjected to veterinary controls that are adapted to the intended use of the tissues. Information on the geographical origin of the animals shall be retained by manufacturers;
b) Sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the device;
c) In the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, state of the art controls shall be put in place.
13.3. For devices manufactured utilizing non-viable biological substances other than those referred to in Essential Principle (13.1) and Essential Principle (13.2), the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.
14. Construction of devices and interaction with their environment.
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14.1. If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling, shall be designed and constructed in such a way as to minimise all possible risks, such as misconnection.
14.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:
a) The risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;
b) Risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences;
c) The risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;
d) The risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;
e) The risks of accidental ingress of substances into the device;
f) The risks of reciprocal interference with other devices normally used in the investigations or for the treatment given; and
g) Risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.
14.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.
14.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
14.5. Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
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<table><tr><td>14.6.</td><td>Any measurement, monitoring or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.</td></tr><tr><td>14.7.</td><td>Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.</td></tr><tr><td>15.</td><td>Devices with a diagnostic or measuring function</td></tr><tr><td>15.1.</td><td>Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods. The limits of accuracy shall be indicated by the manufacturer.</td></tr><tr><td>15.2.</td><td>The measurements made by devices with a measuring function shall be expressed in the International System of Units (SI) according to the Law of Measurement and Calibration</td></tr><tr><td>16.</td><td>Protection against radiation</td></tr><tr><td>16.1.</td><td>General:a) Devices shall be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation is reduced as far as possible, and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.b) The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.</td></tr></table>
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16.2. Intended radiation
a) Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or nonionizing radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.
b) Where devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions.
16.3. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. Where possible and appropriate, methods shall be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.
16.4. Ionizing radiation
a) Devices intended to emit ionizing radiation shall be designed and manufactured taking into account the state of the art safety standards for protection against the dangers arising from exposure to ionising radiation.
b) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.
c) Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose whilst minimising radiation exposure of the patient and user.
d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and, where appropriate, the quality of radiation.
16.5. Imaging medical devices shall be capable of automatically recording dose, protocol data, and patient information such as age, gender and weight in standardized formats.
17. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
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<table><tr><td>17.1.</td><td>Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance.</td></tr><tr><td>17.2.</td><td>For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.</td></tr><tr><td>17.3.</td><td>Software referred to in this Essential Principle that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).</td></tr><tr><td>17.4.</td><td>Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorized access, necessary to run the software as intended.</td></tr><tr><td>18.</td><td>Active devices and devices connected to them</td></tr><tr><td>18.1.</td><td>For non-implantable active devices, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.</td></tr><tr><td>18.2.</td><td>Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical.</td></tr><tr><td>18.3.</td><td>Devices where the safety of the patient depends on an external power supply shall include an alarm system to signal any power failure.</td></tr><tr><td>18.4.</td><td>Devices intended to monitor one or more clinical parameters of a patient shall be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.</td></tr><tr><td>18.5.</td><td>Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.</td></tr></table>
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<table><tr><td>18.6. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended.</td></tr><tr><td>18.7. Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.</td></tr><tr><td>18.8. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against unauthorized access that could hamper the device from functioning as intended.</td></tr><tr><td>18.9. Where the electrical medical device is intended to be connected to an alternating current (AC) power supply, the device shall be:a) designed to operate with a 60 Hertz supply at nominal values of either 230 or 400 volts, andb) fitted with the appropriate AC power connector in accordance with part 401 of SBC and the Saudi standard entitled "Plugs and socket-outlets for household and similar purposes- safety requirements and test methods 250 V/13 A (SASO-2203)".</td></tr><tr><td>18.10. For electrical medical devices, colours of conductors' insulators shall be in accordance with the Saudi Building Code –Electrical Requirements part 401 of SBC.</td></tr><tr><td>19. Particular requirements for active implantable devices</td></tr></table>
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19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:
a) Risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
b) Risks connected with medical treatment, in particular those resulting from the use of defibrillators or high frequency surgical equipment, and
c) Risks which may arise where maintenance and calibration are impossible, including:
- Excessive increase of leakage currents,
- Ageing of the materials used,
- Excess heat generated by the device,
- Decreased accuracy of any measuring or control mechanism.
19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure
- if applicable, the compatibility of the devices with the substances they are intended to administer, and
- the reliability of the source of energy
19.3. Active implantable devices and, if appropriate, their component parts shall be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.
19.4. Active implantable devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.
20. Protection against mechanical and thermal risks
20.1. Devices shall be designed and manufactured in such a way as to protect patients and users against mechanical risks connected with, for example, resistance to movement, instability and moving parts.
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<table><tr><td>20.2.</td><td>Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance</td></tr><tr><td>20.3.</td><td>Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.</td></tr><tr><td>20.4.</td><td>Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks.</td></tr><tr><td>20.5.</td><td>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.</td></tr><tr><td>20.6.</td><td>Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.</td></tr><tr><td>21.</td><td>Protection against the risks posed to the patient or user by devices supplying energy or substances</td></tr><tr><td>21.1.</td><td>Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user.</td></tr><tr><td>21.2.</td><td>Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source.</td></tr><tr><td>21.3.</td><td>The function of the controls and indicators shall be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.</td></tr></table>
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<table><tr><td>22.</td><td>Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons</td></tr><tr><td>22.1.</td><td>Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the layperson's technique and environment. The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply. The user interface of the electronic system shall be in both the Arabic and English languages.</td></tr><tr><td>22.2.</td><td>Devices for use by lay persons shall be designed and manufactured in such a way as to:- Ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information,- Reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and- Reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.</td></tr><tr><td>22.3.</td><td>Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:- can verify that, at the time of use, the device will perform as intended by the manufacturer, and- if applicable, is warned if the device has failed to provide a valid result.</td></tr><tr><td colspan="2">Requirements Regarding Information Supplied with the Device</td></tr><tr><td>23.</td><td>Label and instructions for use</td></tr></table>
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23.1. General requirements regarding the information supplied by the manufacturer.
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:
a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. Information supplied by the manufacturer for devices for use by lay persons shall be in both the Arabic and English languages.
b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
c) Labels shall be provided in a human-readable format and shall be supplemented by machine-readable information, such as radio-frequency identification ('RFID') or bar codes.
d) Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class A and class B devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Essential Principle.
e) Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) and shall meet eIFU requirements set out in Annex (10).
g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contraindications, precautions or warnings in the information supplied by the manufacturer.
h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the recognized standards
i) Labelling shall not include the SFDA logo, but may include the Medical Device National Listing Number.
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23.2. Information on the label
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:
- A medicinal substance, including a human blood or plasma derivative, or
- Tissues or cells, or their derivatives, of human origin, or
- Tissues or cells of animal origin, or their derivatives,
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;
1) 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;
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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.
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23.3. Information on the packaging which maintains the sterile condition of a device ('sterile packaging')
The following particulars shall appear on the sterile packaging:
a) An indication permitting the sterile packaging to be recognised as such,
b) A declaration that the device is in a sterile condition,
c) The method of sterilisation,
d) The name and address of the manufacturer,
e) A description of the device,
f) If the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
g) If the device is custom-made, the words ‘custom-made device’,
h) The month and year of manufacture,
i) An unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and
j) An instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
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23.4. Information in the instructions for use
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:
- details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection,
- identification of any consumable components and how to replace them,
- information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime, and
- methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices;
1) If the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
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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:
- Information to identify such devices or equipment, in order to obtain a safe combination, and/or
- Information on any known restrictions to combinations of devices and equipment;
r) If the device emits radiation for medical purposes:
- Detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation,
- The means of protecting the patient, user, or other person from unintended radiation during use of the device;
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:
- warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety,
- warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature,
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- warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment,
- if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered and identification of their origins,
- warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and
- precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user;
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:
— infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and
— physical hazards such as from sharps. If no instructions for use are required, this information shall be made available to the user upon request;
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;
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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.
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Annex (2): Essential Principles of Safety and Performance for In-Vitro Medical Devices
<table><tr><td>General Requirements</td></tr><tr><td>1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art</td></tr><tr><td>2. The requirement in this annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.</td></tr><tr><td>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:a) Establish and document a risk management plan for each device;b) Identify and analyse the known and foreseeable hazards associated with each device;c) Estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;d) Eliminate or control the risks referred to in point (c) in accordance with the requirements of Essential Principle (4);e) Evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; andf) Based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Essential Principle (4).</td></tr></table>
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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:
a) Eliminate or reduce risks as far as possible through safe design and manufacture;
b) Where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
c) Provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.
Manufacturers shall inform users of any residual risks.
5. In eliminating or reducing risks related to use error, the manufacturer shall:
a) Reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
b) Give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
6. The characteristics and performance of a device shall not be a
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