Algeria medical device regulatory resources

Décret exécutif 20-324 Art. 30: the ANPP must decide within 240 days from the date the file is ruled admissible under Art. 22, and the director general may exceptionally extend that by up to 90 days, which is where the 330-day upper bound comes from

The clock is suspended whenever complementary information is requested, and an application lapses outright if the applicant misses the deadline set for supplying it

The decree states one homologation clock and does not allocate separate clocks by risk class

Arrêté of 23 June 2021 Art. 9: the ANPP must decide within 90 days from admissibility, exceptionally extendable by the director general by up to 30 days

Art. 8 places an internal 60-day step inside that window, within which the dossier and technical evaluation reports must reach the homologation commission, itself extendable by 30 days when complementary information is requested

This route exists because Décret 20-324 Art. 16 carved export-only local manufacture out of the general homologation regime and left it to a ministerial arrêté

A rejected applicant may appeal to the ANPP within 30 days of notification

Arrêté of 23 June 2021 Art. 12: the ANPP must decide within 90 days from receipt of the modification request, exceptionally extendable by the director general by up to 30 days, with the clock suspended while complementary information is outstanding

Art. 9 applies the same 8-day admissibility examination used for original homologation, and an incomplete modification file is declared inadmissible

Art. 14 and 15: after a rejection the holder has 30 days to file a corrected request, which the ANPP must then decide within 30 days