Legislation Details
- Full Title: Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices
- Law Type: Cabinet Resolution
- Law Number: No. (90) of 2023
- Issued Date: 25 Aug 2023
- Effective Date: 29 Sep 2023
- Official Gazette: No. 758
- Sector: Industry and Technical Standardisation
- Status: Active
- Number of Articles: 18
- Chapters/Parts: 0
- Amendments: 0
Summary
This Cabinet Resolution establishes the technical regulation for obligatory requirements on medical and laboratory measuring devices used in the United Arab Emirates. The law aims to ensure the accuracy, safety, and proper use of these critical devices in healthcare settings. It applies to a range of instruments, from clinical thermometers to radiation measurement equipment, and imposes obligations on manufacturers, suppliers, and users to comply with type approval, conformity assessment, and periodic verification requirements. The law is significant for businesses and individuals in the UAE's healthcare sector, as it sets clear standards to enhance patient safety and the reliability of medical diagnostics. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 1-2)
What is the scope and purpose of this law?
The scope of this Cabinet Resolution is to regulate the technical requirements for medical and laboratory measuring devices used in the UAE, including those that are imported or manufactured for use in healthcare facilities. The law applies to a specific list of devices outlined in Article 2, such as digital clinical thermometers, automated sphygmomanometers, and graduated laboratory equipment. The purpose is to ensure the accuracy, safety, and proper use of these critical measuring instruments in order to protect public health and safety. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 2)
What are the key definitions under this law?
The Cabinet Resolution provides the following key definitions:
- State: United Arab Emirates
- Ministry: Ministry of Industry and Advanced Technology
- Competent Authority: Federal and local government authorities responsible for implementing the provisions of this Resolution
- Authorized Entity: Any governmental or private entity authorized by the Ministry to carry out its tasks and powers
- Maximum Permissible Error: The maximum error allowed for a measuring device
- Periodic Verification: Subsequent verification of measuring devices at specified intervals
- Calibration: The processes to determine the efficiency and accuracy of measuring devices
- Standard Specification: A document specifying the characteristics, properties, and requirements of a product or service
- Supplier Name: The manufacturer, importer, or other party responsible for the product
- Health Facilities: Hospitals, clinics, health centers, and laboratories
- Type Approval: A certification that a measuring device meets legal requirements
- Conformity Assessment: Activities to confirm a product meets technical requirements
- Conformity Certificate: A certificate confirming a product's compliance
- Metrological Requirements: A mark certifying a measuring device's verification
- Label Card: A card showing a measuring device's manufacturer, serial number, and other details
(Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 1)
What are the main obligations and requirements?
The Cabinet Resolution imposes several key obligations: 1. Manufacturers and suppliers of medical and laboratory measuring devices must ensure their products comply with type approval and conformity assessment requirements. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 3(1)) 2. Users of these devices must only use them if they carry a valid verification or calibration mark. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 3(2)) 3. Users are responsible for submitting devices for reverification or recalibration if they are maintained or repaired in a way that affects the measurement result. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 3(3)) 4. Verification and calibration of the devices can only be carried out by the Ministry or authorized entities. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 3(4))
What licensing, registration, or approval requirements exist?
The legislation does not specify any licensing, registration, or approval requirements for medical and laboratory measuring devices. It focuses on the technical requirements and obligations related to type approval, conformity assessment, verification, and calibration.
What rights and protections does this law provide?
The legislation does not explicitly outline any specific rights or protections granted to individuals or businesses. The focus is on establishing technical requirements and obligations for the manufacture, supply, and use of medical and laboratory measuring devices.
Which authorities or bodies are responsible for enforcement?
The key authorities and bodies responsible for enforcement under this Cabinet Resolution are: 1. The Ministry of Industry and Advanced Technology, which is empowered to issue executive resolutions, take measures against non-compliant devices, and oversee the implementation of the law. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 6-7) 2. The Competent Authorities, which are defined as federal and local government authorities responsible for implementing the provisions of this Resolution. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 1) 3. Authorized Entities, which are any governmental or private entities authorized by the Ministry to carry out its tasks and powers under the Resolution. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 1, 3(4))
What are the penalties for non-compliance?
The legislation does not specify any penalties for non-compliance with the requirements outlined in the Cabinet Resolution.
What fees, charges, or financial provisions are specified?
The legislation does not mention any fees, charges, or other financial provisions related to the requirements for medical and laboratory measuring devices.
What exemptions or exceptions apply?
The legislation does not provide any exemptions or exceptions to the requirements outlined in the Cabinet Resolution.
How are disputes resolved under this law?
The legislation does not specify any dispute resolution mechanisms or procedures under this Cabinet Resolution.
What are the key deadlines and time limits?
The legislation includes the following key deadlines and time limits: 1. Suppliers must reconcile their activities in accordance with the provisions of this Resolution within a period of six months from the date the Resolution enters into force. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 8) 2. The Resolution shall be enforced 30 days after the date of its publication in the Official Gazette. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 9)
How does this law interact with other UAE legislation?
The Cabinet Resolution states that it repeals the previous 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, as well as any provision that violates or conflicts with the current Resolution. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 7)
When did this law come into effect?
This Cabinet Resolution shall be published in the Official Gazette and shall be enforced 30 days after the date of its publication. (Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices, 2023, Art. 9)
Source Documents
This article analyses Cabinet Resolution Concerning the Technical Regulation for Obligatory Requirements for Medical and Laboratory Measuring Devices for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.