Bahrain Medical Device Regulations

Agency
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 ClassificationExamplesRisk Level
AChemistry analyzerLow
BUrine test stripsLow - Moderate
CBlood Glucose self-testingHigh - Moderate
DHIV blood analyzerHigh
Premarket Approval Process
ABCD
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
ValidityTwo years.
Postmarket Surveillance Some controls in place.
TimelineApproximately two months.
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