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 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.
Postmarket Surveillance	Some controls in place.
Timeline	Approximately two months.

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