Azerbaijan medical device regulations

Azərbaycan Respublikası Nazirlər Kabinetinin 2024-cü il 18 iyul tarixli 345 nömrəli Qərarı, signed in Baku on 18 July 2024. Its first three items approve the Rules for state registration, entry in the state register and keeping of the state register of medicines, pharmaceutical substances and medical devices (the Rules are annexed to the decision); repeal Cabinet Decision No. 108 of 13 July 2007 on the same ground; and provide that amendments to the decision may be made under §3.5 of the Regulation approved by Presidential Decree No. 2328 of 6 October 2023. The Rules run to 13 sections (§1 general provisions, §2 concepts, §3 registration of medicines and substances, §4 registration and re-registration of medical devices and changes to their registration documents, §5 grounds of refusal, §6 certificates for medicines and substances, §7 certificates for medical devices, §8 validity, §9 approval of instructions for use, §10 the state register, §11 suspension, §12 cancellation, §13 confidentiality) and nine appendices. Device-specific content: only devices of higher-than-high, high and/or medium risk are state-registered at all (§1.2.3, §4.2); the applicant files the documents of §4.2.1–4.2.11, several of which are excused for devices manufactured in Azerbaijan and for in-vitro diagnostic devices (§4.3); the Ministry issues the certificate within 7 working days on the form of Appendix No. 5 (§7.1), and a new certificate for changes to its particulars on the form of Appendix No. 6 (§7.2); the certificate is valid for 5 years (§8.1); the state register records the device's risk degree (§10.4.3). Appendices Nos. 5 and 6 are the medical-device certificate forms (headed "TV №"); Appendices Nos. 2A–4B are the medicinal-product and substance certificate forms ("DV №"); Appendix No. 1 is the application form. Ingested in Azerbaijani from the Cabinet of Ministers' own PDF.