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Bahrain Medical Device Regulations


Regulatory Authority

All medical devices are regulated by the Pharmaceutical Product Regulatory Office (PPRO) of the National Health Regulatory Authority (NHRA).

 

Medical Device Definition

Means all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability that does not achieve its action by pharmacological, immunological, or metabolic means.

 

Classification of Medical Device

 

International Classification

Examples

Risk Level

A

Chemistry analyzer

Low

B

Urine test strips

Low - Moderate

C

Blood Glucose self-testing

High - Moderate

D

HIV blood analyzer

High

 

Premarket Approval Process

 

A

B

C

D

Appoint an authorized representative (AR) in Bahrain to submit application.

Fill out application form and submit all required documents (listed below).

If approved, applicant will receive a registration certificate

 

List of Required Documents

 

  • Application form
  • CFS
  • Quality system certification
  • QMS
  • User manual
  • Declaration of conformity

 

Additional Information

 

Validity

Two years.

Post market Surveillance

Some controls in place.

Timeline

Approximately two months.