قانون الرعاية الصحية / الأدوية في الإماراتقرار مجلس الوزراء في شأن اللائحة الفنية للمتطلبات الإلزامية لأدوات القياس الطبية والمخبرية

Article (1) Definitions In application of the provisions of this Resolution, the words and expressions set forth herein shall bear the meanings ascribed to them, unless the context otherwise requires: State : United Arab Emirates. Ministry : Ministry of Industry and Advanced Technology. Competent Authority : Federal and Local Government Authority in the State that falls within its jurisdiction to implement any of the provisions of this Resolution. Authorized Entity : Any Governmental Entity, whether Federal, Local or Private, authorized by the Ministry to carry out any of its tasks and powers stipulated in the provisions of this Resolution. Maximum Permissible Error : The Maximum Permissible Error of the Measuring Device specified in this Resolution, not to be exceeded. Periodic Verification : A subsequent Periodic Verification carried out on Measuring Devices at specified intervals, according to a procedure stipulated in Metrological Regulations.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 2 Calibration : The processes that are conducted to determine the efficiency and accuracy of Measuring Devices and Instruments. Standard Specification : A document specifies the characteristics of the commodity, product, service, or everything that is subject to measurement, its description, properties, quality level, dimensions, metrics or safety and security Requirements therein. It also includes terms, symbols, testing methods, sampling, packaging, labels and marks. Supplier Name : The Manufacturer, importer, carrier, assembler, agent, warehouse, or any major or subsidiary distributor whose activity has an impact on the characteristics of the product, or any legal representative who is responsible for the import, installation, and operation of the product subject to the provisions of this Resolution, and who carries out his activity through a licensed company or individual establishment in the State in accordance with the relevant legislation. Health Facilities : Hospitals, Clinics, Health centres and Laboratories. Type Approval : A Resolution issued, based on the type assessment report, certifying that this type of Measuring Device meets its legal Requirements, and accordingly issues a Type Approval Certificate. Conformity Assessment : Any Activity used directly or indirectly to confirm that the good, product, material, or service meets the relevant technical Requirements. Conformity Certificate : A Certificate issued by the Ministry, or the Conformity Assessment Entity which confirms the Conformity of the Product or any Batch thereof to the Requirements of the Approved Standard Specifications. Metrological Requirements : A mark affixed to a Measuring Device clearly certifying that Verification of the Measuring Device has been carried out and its Conformity with legal Requirements. Label Card : Card that shows the name and address of the Manufacturer of the Measuring Device or the address of the importer, the serial number of the Measuring Device, its type or model, its function, characteristics,

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 3 classification, method of use, capacity or load, Scale, year of manufacture, and any other obligatory basic information.

Article (2) Scope of Application This Resolution shall apply to the following legal Measuring Devices used in Health Facilities, and also shall apply to Devices imported or manufactured for these purposes, which include the following: 1. Digital Clinical Thermometers. 2. Electrical Medical Clinical Thermometers. 3. Non-invasive mechanical automated Sphygmomanometers. 4. Non-invasive automated Medical Sphygmomanometers. 5. Glass Automatic Pipettes. 6. Graduated Pipettes. 7. Graduated Flasks. 8. Pycnometers. 9. Burettes. 10. Graduated Cylinders. 11. Medical Syringes. 12. Measurement Devices that are verified using reference materials. 13. Equipment for measuring doses of ionising radiation. 14. Measuring Devices that shall have a Calibration Certificate.

Article (3) Responsibilities 1. The Local Manufacturer or Supplier of the Medical and Laboratory Devices mentioned in this Resolution shall be responsible for all these Devices compliance with the Requirements for Type Approval and Conformity Assessment.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 4 2. The User of Medical and Laboratory Devices shall be responsible for using them if they do not carry a valid Verification or Calibration mark, in accordance with what this Resolution stipulates in the Requirements for each Device shown in the Attachments to this Resolution. 3. The Medical and Laboratory Measuring Device loses the validity of the Verification or Calibration period if it is maintained or repaired in the area that affects the measurement result, and the User is considered responsible for submitting his Device for the purposes of reverification or Calibration. 4. Verification or Calibration Operations for the Medical and Laboratory Devices mentioned in this Resolution may only be carried out by the Ministry and Authorised Entities.

Article (5) General Provisions 1. If it is proven that the Medical and Laboratory Measuring Device does not meet the Requirements stipulated in this Resolution, and that this defect in the Device is a systemic defect, the Ministry has the right to take all necessary measures, including withdrawing it from the market, restricting or restricting its use in a specific Domain, or requesting that its conditions be corrected. Although certificates of Conformity are available.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 5 2. In the event that a Medical or Laboratory Measuring Device requires frequent maintenance of the part related to the measurement result, during the Verification period, the Ministry may refuse to grant the Device the Periodic Verification mark and/or not allow it to be put into use and/or confiscate it. 3. In the event that any of the Requirements stipulated in this Resolution conflict with the specifications referred to in this Resolution, the provisions of the standard specification shall apply. 4. If it is proven that an entity has installed metrological marks or issued a Verification report or certificate of Conformity, unlawfully, or without confirming that the Device conforms to the Obligatory Requirements, the Ministry has the right to take all appropriate measures to ensure that the violation is not repeated, including cancelling recognition of the issued certificates. On behalf of the party that issued it, or referring the violating party to the judiciary. 5. This Resolution does not prevent the Ministry inspectors, the authorities authorised by it, or the Competent Authorities from conducting other Examinations to ensure that these Devices mentioned in this Resolution conform to the Obligatory Requirements stipulated in the technical regulations or other legislation in force in the State. 6. All parties concerned with this Resolution shall provide the Ministry inspectors, the authorities authorised by it, or the Competent Authorities with all the assistance and information they request related to implementing the provisions of this Resolution with ease and ease. 7. In order to achieve the public interest, the Ministry may take what it deems appropriate regarding cases that cannot be addressed in accordance with the provisions of this Resolution or if a dispute arises over its interpretation or application, and the Ministry may base this on prevailing international practices in this Domain.

Article (9) Publication and Entry into Force This Resolution shall be published in the Official Gazette and shall be enforced thirty (30) days after the date of its publication. Mohammed bin Rashid Al Maktoum Prime Minister Issued by Us: On: 8 Safar 1445 A.H. Corresponding to: 25 August 2023 AD

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 7 Attachment No. (1) Digital Clinical Thermometers 1.1 Domain: The Requirements in this Attachment apply to Digital Clinical Thermometers with maximum temperature determination. Designed to measure a person internal temperature, excluding Thermometers designed to measure skin temperature. 2.1 Definitions The Definitions contained in International Organisation of Legal Metrology Recommendation No. OIML R115 shall be considered an integral part of Attachment No. (1) of this Resolution. 3.1 Degrees of control and scale: 1. Control-grade Thermometers, a scale of C° 0.001 2. Control-grade Thermometers, a scale of C° 0.01 4.1 Design Requirements: 1. Digital Clinical Thermometers shall be manufactured in accordance with the International Organisation for Legal Metrology Recommendation No. OIML R115, to the extent that it does not conflict with this Resolution. 2. The Measurement Range shall be at least from 35.5°C to 42.0°C, and when the Measurement Range is larger, the Measurement Range can be divided into partial periods, while the range from 35.5°C to 42.0°C shall be kept continuous. 3. The Temperature Measurement Units shall be expressed in C°. 4. The Manufacturer shall determine the response time for the measurement. 5. The Thermometer may be an interchangeable probe attached to indicator unit consistent with the response characteristics of the probe or a probe permanently attached to the indicator unit. 6. Weak value of the Electric Power Source shall not lead to giving incorrect measurement values. 7. Signs and explanatory data: a. Manufacturers shall provide the necessary space for metrological markings. b. Manufacturers shall install the following signs and explanatory information on the Thermometer or its separate parts: - Name and address of the Manufacturer or Supplier, and/or brand.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 8 - Make, model, Batch number or serial number. - Indicator of the direction or position used, where appropriate. c. Single-use thermal sensors shall be sealed inside a package containing the full information and Measurement Range, in addition to providing appropriate space on the package to place metrological marks. It shall also be clear whether the package has been opened, in addition to providing a statement indicating that the User may not open the package except immediately before use. 8. Labelling. The Manufacturer shall provide the User with Instructions Guide, including the following information: 1. Correct and safe use. 2. Measurement Range. 3. Directions and warnings for cleaning and sterilising the Scale. 4. Illustration of appropriate equipment and variable parts such as sensors and batteries including the value. 5. Nominal voltage difference if possible. 6. Minimum time to reach thermal equilibrium. 7. Describe the transition from the expected temperature measurement state to the actual temperature measurement state. 8. Self-Examining Device instructions. 9. Suitable weather conditions for using, storing and transporting the Scale. 10. Periodic maintenance. The Manufacturer shall also provide the Medical Thermometer with certain specific information upon request regarding the possibility of substandard performance if used under the influence of the following conditions: - Outside the climatic conditions in terms of temperature and humidity previously described. - After accidental mechanical shock. 5.1. Maximum Permissible Error The Maximum Permissible Error Values under the influence of reference conditions shall be in accordance with what is shown in Table (1-1)

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 9 Table (1-1). Maximum Permissible Error Maximum Permissible Error Out of Range From C° 35.5 to C° 42.0 Within Range From C° 35.5 to C° 42.0 Accuracy Scale C° 0.30± C° 0.15± Class I C° 0.4± C° 0.2± Class II 6.1 Reference conditions for measurement: - Ambient temperature – (C° 5 ± C° 23). - Relative humidity = (50 ± %20). - Battery voltage difference within the range specified by the Manufacturer. 7.1 Type Approval Requirements: 1. Importers or Manufacturers of Digital Clinical Thermometers shall submit a Type Approval Certificate in accordance with this Resolution, issued by an internationally recognised body or approved by the Ministry. 2. If the Type Approval Certificate is unavailable, three samples shall be taken to conduct possible tests on them in accordance with this Resolution. 8.1 Requirements of the Conformity Assessment 1. Importers or Manufacturers of Digital Clinical Thermometers shall submit a Type Conformity Certificate in accordance with this Resolution, issued by internationally recognised body or approved by the Ministry. 2. The Ministry shall take samples for the purposes of accepting or rejecting the Batch according to Table (M1-3) shown in Attachment (1) to conduct possible tests on them.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 10 9.1 Initial Verification Requirements: 1. For the purposes of Conformity with the Initial Verification Requirements, the following Examination shall be performed: a. Virtual Examination. b. Maximum Permissible Error Examination. 2. No party may use a Medical Thermometer that has not been verified by Entity approved by the Ministry. 3. The Supervised Entity shall bear all costs of the Initial Verification. 10.1 Periodic Verification Requirements: 1. Medical Thermometers shall be examined periodically on annual basis. 2. For the purposes of Periodic Verification, the Initial Verification Requirements stated in Clause 1.9 of this Attachment are applied. 3. No party may use a Medical Thermometer that has not been verified by Entity approved by the Ministry. 4. The Supervised Entity shall bear all costs of the Periodic Verification. 11.1 Periodic Verification Requirements: 1. The Ministry has the right to conduct Sudden Verification on all Licensed Entities in the Domain of manufacturing, importing, renting and using Medical Thermometers to indicate the extent of their compliance with this Resolution. 2. The Ministry shall bear all costs of the Sudden Verification if the results are consistent, while the Supervised Entity shall bear all costs if the Verification results are not in accordance with this Resolution. 12.1 Verification Procedures The Ministry shall prepare Examination and Verification Procedures in accordance with the recommendations of the International Organisation of Legal Metrology or accepted international practices in this Domain. 13.1 References Recommendation of the International Organisation of Legal Metrology No. OIML R115

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 11 Attachment No. (2) Electrical Medical Clinical Thermometer 1.2 Domain: The Requirements in this Attachment apply to all Electrical Medical Clinical Thermometers. 2.2 Definitions The Definitions contained in International Standard ISO 80601-2-56:2017 shall be deemed an integral part of Attachment No. (2) of this Resolution. 3.2 Design Requirements: 1. Electrical Medical Clinical Thermometers shall be manufactured in accordance with International Standard ISO 80601-2-56:2017 to the extent that does not conflict with this Resolution. 2. The Measurement Range shall be at least from 34°C to 43.0°C, and when the Measurement Range is larger, the Measurement Range can be divided into partial periods. 3. The Temperature Measurement Units shall be expressed in C°, and the Fahrenheit unit may be used in addition to it. 4. Maximum Permissible Error: a. The Maximum Permissible Error Values for the range C°34 to C° 43 and under ambient conditions from 16 to 35°C and a relative (non-condensing) humidity of up to a minimum of 85% shall be C°0.3±. b. The Maximum Permissible Error Values out of the range C°34 to C° 43 and out the ambient conditions from 16 to 35°C and a relative (non-condensing) humidity of up to a minimum of 85% shall be C°0.4±. 5. The Thermometer shall maintain the Maximum Permissible Error limits when stored in conditions from 20 to 55°C and non-condensing relative humidity up to (85%) for a period of 28 days. 6. Electromagnetic Approval: The Thermometer shall meet the Requirements of EN 6061-2-1 for Electromagnetic Approval. 7. Mechanical Shock: The Thermometer shall meet the Requirements of ISO 80601-2-56:2017 for tolerance to mechanical shock.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 12 8. Unit for displaying the measurement value: a. The height of the numbers appearing on the screen shall be 4 mm or it shall be equipped with a magnifying lens to give the numbers the desired size. b. The Meter shall give visual warning signals or not display a measurement value when one or more of the following falls outside the limits stated by the Manufacturer: – The value of the Electric Voltage Source. – Measurement Range. – The Ambient Temperature Range. 9. Fluctuation in the value of the Electric Power Source: The Thermometer shall meet the Requirements of ISO 80601-2-56:2017 for fluctuation of the value of the electrical power supply. 10. Thermometer working systems: The Thermometer shall meet the Requirements of International Standard ISO 80601-2-56:2017 materials, cleaning and sterilisation methods, use and safety. 11. The signs and explanatory and indicative data that shall be provided by the Manufacturer. The Thermometer shall meet the Requirements of International Standard ISO 80601-2-56:2017 regarding the signs and explanatory and indicative data that shall be provided by the Manufacturer. 4.2 Type Approval Requirements: 1. Importers or Manufacturers of Electrical Medical Clinical Thermometers shall submit a Type Approval Certificate in accordance with this Resolution, issued by an internationally recognised body or approved by the Ministry. 2. If the Type Approval Certificate is unavailable, three samples shall be taken to conduct all possible tests on them in accordance with this Resolution. 5.2 Requirements of the Conformity Assessment 1. Importers or Manufacturers of Electrical Medical Clinical Thermometers shall submit a Type Conformity Certificate in accordance with this Resolution, issued by internationally recognised body or approved by the Ministry. 2. The Ministry shall take samples for the purposes of accepting or rejecting the Batch according to Table (M1-3) shown in Attachment (1) to conduct possible tests on them.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 13 6.2 Initial Verification Requirements: 1. For the purposes of Conformity with the Initial Verification Requirements, the following Examination shall be performed: a. Virtual Examination b. Maximum Permissible Error Examination 2. No party may use a Medical Thermometer that has not been verified by Entity approved by the Ministry. 3. The Supervised Entity shall bear all costs of the Initial Verification. 7.2 Periodic Verification Requirements: 1. Electric Thermometers shall be examined periodically on annual basis. 2. For the purposes of Periodic Verification, the Initial Verification Requirements stated in Clause 6-2 of this Attachment are applied. 3. No party may use a Medical Thermometer that has not been verified by Entity approved by the Ministry. 4. The Supervised Entity shall bear all costs of the Periodic Verification. 8.2 Sudden Verification Requirements: 1. The Ministry has the right to conduct Sudden Verification on all Licensed Entities in the Domain of manufacturing, importing, renting and using Medical Thermometers to indicate the extent of their compliance with this Resolution in coordination with the various Licensing Authorities of Health Facilities using the Concerned Devices. 2. The Ministry shall bear all costs of the Sudden Verification if the results are consistent, while the Supervised Entity shall bear all costs if the Verification results are not in accordance with this Resolution. 9.2 Verification Procedures The Ministry shall prepare Examination and Verification Procedures in accordance with the recommendations of the International Organisation of Legal Metrology or accepted international practices in this Domain. 10.2 References: International Standard: 2017:56.2.80601 ISO

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 14

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 15 Attachment No. (3) Non-Invasive Mechanical Automated Sphygmomanometers 1.3 Domain: – Mechanical and pneumatic Sphygmomanometers and their parts and accessories. 2.3 Definitions The Definitions contained in International Organisation of Legal Metrology Recommendation No. OIML R 16-1:2002 shall be considered an integral part of Attachment No. (3) of this Resolution. 3.3 Technical Requirements 1. Mechanical Medical Sphygmomanometers, parts and accessories contained in this Attachment shall meet the Requirements contained in OIML Recommendation R 16-1, to the extent that they are not inconsistent with this Resolution. 2. Measurement Units: The value of Arterial Blood Pressure shall be expressed in (kpa) or (mm Hg). 3. Maximum Permissible Error for Cuff Pressure Indication: A. Under the influence of Ambient Weather Conditions: The Maximum Permissible Error Value for any point of the Scale within the Ambient Air Temperature from 15° to 25°C and relative humidity within the range from 20% to 85% shall not exceed (± 3 mm Hg) in the case of Initial Verification and ± 4 mm Hg)) in case of Subsequent Verification. B. Under Storage Conditions: The Arterial Blood Pressure Monitor shall maintain the Maximum Permissible Error Value Requirements after storage for 24 hours at 20°C and at –70°C and 85% relative humidity (Non- condensing) for another 24 hours. C. Under the influence of changing temperatures: Under the influence of a range of air temperatures from 10 to 40°C and a relative humidity of 85% (Non-condensing), the difference in the value of the Cuff pressure of the pressure Measuring Device shall not exceed (±3 mm Hg) 4. Technical Requirements for the Cuff and Pressure Fascia: – The Cuff shall contain Pressure Fascia. If it may be used for more than once, the Manufacturer shall indicate how to clean it.

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Cabinet Resolution of 2023 Concerning the Technical Regulations for Obligatory Requirements for Medical and Laboratory Measuring Devices 16 5. Technical Requirements for the compressed air system: A. The pressure drop due to air leakage shall not exceed mmHg/4 min. B. The manual vacuum valve shall be able to easily adjust the pressure drop rate (2 mmHg/s - 3 mmHg/s). C. The time for rapid pressure relief from (260 mmHg) to (15 mmHg) shall not exceed 10 seconds. 6. Technical Requirements for pressure indication means: A. The minimum Nominal Range of the manometer shall be (0 mmHg/s - 260 mmHg) B. The pressure gauge scale shall be designed to be ea