Medical Equipment Importation License Request

This service is provided by the National Health Regulatory Authority to Businesses requesting to obtain a license to import medical equipment. Medical equipment includes all products used in the healthcare field for diagnosis, prevention, monitoring or treatment of any illness or disability that cannot be achieved by pharmacological, immunological or metabolic means.

group_work   Available Channels

Contact Information

eKiosks

Mobile Applications

Service Location

   Service Terms

  • Target User Group:
  • Business ,

   Required Documents

 

  1. Medical Equipment Registration Form
  2. Cover letter from the supplier stating the name of the end-user (if applicable) and the type of equipment such as spare parts or new devices in addition to detailed information of the devices
  3. Copy of the importer’s valid Commercial Registration of the medical device importation and includes medical equipment activity
  4. Universal Medical Device Nomenclature System (UMDNS) or Global Medical Device Nomenclature System (GMDNS) code number
  5. Copy of quality management certifications (GMP or ISO or FSC or Full Quality Assurance)
  6. Copy of quality Certificates (FDA or CE Mark)
  7. Copy of product label
  8. Original and copy of invoice
  9. Product technical specification

 

   Important notes

  • Readiness:

Official Authorization from the company to the authorized local agent in the Kingdom of Bahrain

  • Others:

Applicant should be a local agent

   Payment

  • Payment Methods: