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.
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, classification, method of use, capacity or load, Scale, year of manufacture, and any other obligatory basic information.
 

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.

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. 
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.

1. When importing any Medical or Laboratory Measuring Devices, it shall be ensured that there are means to confirm these Devices, provided that the means of Verification are accepted by the Competent Authorities and conform with standard public Health and occupational safety standards to reduce any potential risks. 
2. Import and use of mercury Thermometers for Medical uses at Health Facilities shall not be permitted. 
3. Import and use of mercury Sphygmomanometers for Medical uses at Health Facilities shall not be permitted. 
4. Use of Medical Syringes more than once at Health Facilities shall not be permitted.
 

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. 
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.
 

The Minister, in coordination with the Minister, shall issue the Resolutions necessary to apply the provisions of this Resolution.

The Resolution of the Chairman of the Board of Directors regarding the approval of Technical Regulation No. (2) of 2012 for Obligatory Requirements for Medical and Laboratory Measuring Devices shall be cancelled, as well as every provision that violates or conflicts with the provisions of this Resolution.

Suppliers shall reconcile in accordance with the provisions of this Resolution within a period of six months as of the date on which this Resolution enters into force.

This Resolution shall be published in the Official Gazette and shall be enforced thirty (30) days after the date of its publication.