BH Bahrain
  • 11 - Health care technology

Medical Devices and Accessories

Technical Regulation Medical Devices and Accessories (9 page(s), in Arabic)

The Technical Regulation for Medical Devices and Accessories, drafted by Ministry of Industry, Commerce & Tourism in coordination with National Health Regulatory Authority (NHRA) aims to regulate the medical devices and accessories by specifying the mandatory safety and quality requirements set out in the National standards where the devices must comply. The TR ensures that the medical devices should be designed in such a way that, when used under the conditions and for the purposes intended will not compromise the clinical condition or the safety of patients, or the safety and health of users or other persons, and to facilitate market surveillance.