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/
Device Classification Guidelines Medical Device Classification Guideline | Click Here
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
Labeling Requirements

Medical Devices Labeling Guideline

| Click Here
Clinical Trials Information

Conducting Medical Device Clinical Trials in Bahrain

| Click Here
Fees for Submission

Medical Device Fees for Submissions

| Click Here
Declaration of Conformity

Declaration letter or Declaration of Conformity (DOC) issued by the legal manufacturer including the risk classification and the GMDN code.
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.
Adverse Event Reporting Timelines

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 -

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

Recall and Field Safety Notice Guideline

| Click Here
Advertising and Promotions

Medical Devices Advertising Guideline

| Click Here
Additional Information

Medical devices registration is going to be mandated by the 1st of February 2026.
Contact Phone +973 17 113 333
Contact Email Medical_Devices@nhra.bh
Contact Address National Health Regulatory Authority Floor no 10 Al Khair Tower 2 Building no 612, Road no 1011,Block no 410 Sanabis P.O. Box 11464 Manama Kingdom of Bahrain
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 31/Aug/2025

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