Bahrain medical device regulatory resources

Registration Guideline Version 9.1, general rule 11: 'The timeframe of registration application review is 20 working days.' Section 3 repeats it: 'The review process timeframe is 20 working days.'

This is the registration review clock and not the classification clock: the classification letter is a separate fee-bearing service on its own clock.

The same 20 working days is granted for all classes that must be registered (IIa, IIb and III; IVD B, C and D), so the clock is a property of the route rather than of the risk class.

An application that does not fulfil all requirements is returned with the recommended action; the applicant has two further submission attempts without repaying the application fee, and rejection on the third attempt requires the fee to be paid again.

The 2025 SLA states the same figure of 20 working days for the registration service.

Registration Guideline Version 9.1, general rule 11: 'Fast track (Through third party services) is also available with a time frame of 10 working days.'

The 2025 SLA carries the same fast-track figure. The guideline does not restrict the fast track by risk class, so the clock is a property of the route.

Classification Guideline Version 2.4, section 2: 'Timeline for reviewing the submitted documents after fees payment is 1 to 2 weeks.'

The clock runs from payment, and the guideline warns that classification is not accepted for products with different intended uses in one application (up to 10 doses or sizes), and that three failed submissions make the request a new fee-bearing request.

The letter relates to the submitted product only and does not cover other sizes or lot numbers, and it must be obtained before importation and before registration.

Registration Guideline Version 9.1, section 9 general directions: 'Timeframe of NHRA review is 20 working days.'

The applicant must inform NHRA instantly by email on receiving a change notification from the manufacturer; the variation must be approved before the amended device is imported.

A change in risk classification, in the legal or physical manufacturer or address, or in the manufacturing process is a major variation and requires a new registration application, not this clock.

This is the figure printed in the guideline currently served by NHRA. The round-204 reliance research recorded 40 working days for the variation clock with a quotation that does not appear in Version 9.1 — the string '40' does not occur anywhere in the served PDF. See unresolved.variationClock.