Importer Services in Bahrain

‘Importer’ Means any natural or legal person in the supply chain who is the first to make medical device, manufactured in another jurisdiction, available in Bahrain.

The National Health Regulatory Authority (NHRA) in Bahrain oversees the importation of medical devices, with importers bearing key responsibilities:

1. Pre-approval: Importers must obtain NHRA pre-approval via the Ofoq online system, submitting necessary documents.

2. Classification: Devices are categorized by risk level; importers must adhere to applicable regulations.

3. Documentation: Detailed documentation, in English or Arabic, including technical specs, is required.

4. Quality Assurance: Devices must meet quality, safety, and performance standards like ISO 13485.

5. Labeling and Packaging: Devices must be properly labeled and packaged for the Bahraini market.

6. Post-market Surveillance: Importers must monitor device performance and report adverse events.

7. Regulatory Compliance: Importers must adhere to all relevant regulations and guidelines.

8. Authorized Representative: An authorized representative in Bahrain must be appointed for communication with the NHRA.

9. License Renewal: Importers must renew licenses every three years.

10. Continuous Improvement: Importers must continually enhance processes to comply with evolving regulations.