Bahrain - Top Medical Device Alerts

1/17/2023
Circular No. (2) 2023: Authorized representatives scope verification with the imported shipments The National Health Regulatory Authority would like to announce the initiation of scope verification for authorized representatives with the scope of importation shipments as part of the importation applications review process.
2/19/2023
Online Medical Device importation approval Guideline (OFOQ) This guideline is intended to highlight the process and requirements to get the pre-approval of medical device importation through the OFOQ system.
3/22/2023
Medical Devices Registration Guideline. "The new version of the Medical Devices Registration Guideline in Bahrain. Note: The new version's implementation date will start on April 23, 2023. "
12/28/2022
Annoncement for Ajheza System The national health regulatory authority would like to announce the new method of submission for medical device authorized representatives and medical device registration applications through the AJHEZA system that will replace the current submission method done through email. The implementation of the new method started on the 2nd of January, 2023.
8/22/2022
Accrediting Al Bastki training and consulting company The National Health Regulatory Authority would like to announce the accreditation of Al Bastaki Training & consultation company services to facilitate the process of importing medical device supplies and to applicants facing difficulties in preparing the required documents to speed up the importation process.
How can RegDesk help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.

RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.

Get the report