The National Health Regulatory Agency (NHRA) in Bahrain, has released a circular regarding the importation of medical devices to the country. Medical device shipments must now be pre-approved by the NHRA before arriving at Bahrain’s ports. Failure to get pre-approval will result in demurrage charges while the shipment is at the port and, beginning April 1, 2018 the customs department will return such shipments.

The NHRA has also ended the grace period for compliance with the combination device regulations. All combination devices must now be in compliance with the Combined Medical Device Guideline.

There is also an updated list of countries from which Free Sales Certificates for combination devices can be used. They are:

  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Iceland
  • Ireland
  • Italy
  • Japan
  • Luxembourg
  • Netherlands
  • New Zealand
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom
  • United States of America


RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at or visit