Minor variation approval; major variation requires a new registration application
Bahrain distinguishes minor variations, which do not affect safety or performance (renewal of any certificate or official letter, artwork or label changes, IFU changes, authorized-representative detail changes, device name or product identifier change, and adding devices to a licence for colour, package-quantity or volume variants, not applicable to IVDs), from major variations, which do affect safety or performance (change of legal or physical manufacturer or address, manufacturing process change, design or detailed specification change, risk-class change). A minor variation is approved by letter after review; a major variation requires a new registration application.
- NHRA must be informed instantly by email on receipt of a change notification from the manufacturer; NHRA review of a variation is 20 working days (Registration Guideline 9.1, section 9 'General directions')
- Approval of the variation must be finalised before importation of the amended device
- Price changes do not require a variation; the certificate validity does not change
- Software: a variation is required for each new version; updates that affect the intended use are major
Registration Guideline 9.1, section 9, distinguishes minor changes from changes affecting safety or performance. Major variations require a new registration application. The guideline states a 20-working-day NHRA review period; the earlier 40-day transcription was incorrect.