Montenegro medical device regulatory resources

Čl. 40(1) gives CInMED 90 days from receipt of complete documentation to decide on the registration application; the period does not vary by risk class, which is why the row is bound to the route rather than to a class.

Čl. 40(3) allows a 30-day period to remedy an incomplete application, and čl. 40(4) suspends the 90-day clock for as long as the application is incomplete.

Čl. 41(2) gives a Class I device that is neither sterile nor has a measuring function, and an 'other' in vitro diagnostic device, a five-year registration on the manufacturer's own declaration; for every other device čl. 41(1) ties the validity to the conformity document, up to 60 days beyond its expiry.

The same čl. 40(1) clock of 90 days from complete documentation applies to Class IIa, IIb and III; the statute sets no separate period per class.

The clock is administrative only: it starts when the documentation is complete, and for these classes the conformity assessment itself is performed by a notified or appointed body under čl. 18, whose duration the Law does not fix.

Čl. 67(2) gives CInMED 30 days to decide the request; the period is not expressed per risk class, so the row is bound to the import-authorisation route.

This is a permit clock, not a registration clock: it lets an unregistered device be imported without being entered in the register.

Čl. 94(1) gives CInMED 40 days from a complete request, including the positive opinion of the ethics committee, to decide on the start of a clinical investigation.

Čl. 94(2) requires a notice of incompleteness within 10 days and gives the applicant 20 days to supplement; čl. 94(3) suspends the 40-day clock while the request is incomplete.

Čl. 101(3) requires CInMED to issue a certificate of receipt within 15 days for a post-market non-interventional study.