Medical Device Regulatory Requirements in Bahrain

Regulatory Authority National Health Regulatory Authority (NHRA)
Regulatory Authority Website Link Click Here
Device Classification I, IIa, IIb, III
Medical Device Regulations Medical Device Regulation (Same Regulations for IVD) | Click Here
IVD Classification A,B,C,D
In Vitro Diagnostics Regulations https://www.nhra.bh/Departments/MDR/
Registration Process Medical Device Registration | Click Here
Registration Timeline 2 months
Technical Documentation Format

User manuals, catalogs, or service manuals offer detailed information about the device's design, function, and maintenance. 
1. Instructions for Use (IFU)
2. Device Labeling
3. Assurance Certificates
4. Quality Management System Certificates
5. Free Sale Certificate (FSC)
6. Declaration of Conformity
7. List of Countries Where Marketed
8. Recall History
9. Authorized Representative Agreement

| Click Here
Requirement of Authorized Representative YES
Language Requirement Labels must be in Arabic or English Language
Declaration of Conformity

Declaration of Conformity (DOC) as per EU regulations issued by the legal
manufacturer. GMDN code can be included in the DOC or in a separate official letter.
Certificate of Free Sale

In Bahrain, the National Health Regulatory Authority (NHRA) requires a Certificate of Free Sale (CFS) as part of the medical device registration process. A CFS is an official document issued by the regulatory authority in the device's country of origin, confirming that the medical device is legally sold or distributed in that country.
Post Market Surveillance

Reporter -Manufacturer 
Type of problem -Death / Serious injury report to NHRA in  10 working days, Other Problems not associated with high risk or injury report to NHRA in 30 working days.

Reporter- AR / Supplier Type of problem - Death / Serious injury report to NHRA/Manufacturer in  10 working days, Other Problems not associated with high risk or injury report to NHRA/ Manufacturer in 30 working days.


Reporter- Healthcare Facilities
Type of problem - Death / Serious injury report to NHRA/Manufacturer/Supplier in  10 working days, Other Problems not associated with high risk or injury report to NHRA/ Manufacturer/Supplier in 30 working days.

| Click Here
Adverse Event Reporting Form Download
Field Safety Corrective Action

1. FSN issued from the Manufacturer
2. Received by Authorized Representative 
3. Notify NHRA and End-user 
4. Required action taken by AR 
5. AR provides end user acknowledgment
6. After notifying Public/Record Filed with Medical Device

| Click Here
Recalls

If the Bahrain market is not affected by the FSNs (i.e. affected medical device by the FSN is not marketed or distributed in Bahrain) then an official letter from the manufacturer should be provided to NHRA by the local agent confirming that Bahrain market is not affected by the FSN.

If the Bahrain market was affected by the FSN (i.e. affected medical device by the FSN is marketed or distributed in Bahrain), Once the local agent receives a FSN issued from either the manufacturer or international regulatory authorities, a copy of the notice must be provided to the end-users by the agent within:
 2 working days in case of very high risk FSNs.
 5 working days in case of high risk FSNs.
10 working days in case of moderate risk FSNs.
Additional Information

Medical devices registration is going to be mandated by the 1st of February 2026.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 28/Apr/2025

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