Azerbaijan Medical Device & IVD Registration
Azerbaijan has introduced a structured state registration framework for medical devices under the Rules approved by the Cabinet of Ministers by Decision No. 345 dated 18 July 2024.
Under this framework, higher, high, and/or medium risk medical devices are subject to state registration by the Ministry of Health before they can be imported, manufactured, sold, or used in Azerbaijan.
The registration process generally includes application submission, documentation review, examination where applicable, and issuance of a registration certificate. If the submitted documents are complete, the certificate is issued within 7 working days. Where deficiencies are identified, the applicant must address them within 10 working days.
The registration dossier may include manufacturer authorization evidence, registration or Free Sale / Export certificate documents, Azerbaijani translations, product description, labeling and packaging information, safety and effectiveness declaration, QMS certificate, and product-specific documents for sterile devices or devices containing medicinal substances.
Labeling and packaging materials should include Azerbaijani-language content and color mock-ups. Consistency between certificates, technical documentation, labeling, packaging, and application documents is critical to avoid authority questions or delays.
The medical device registration certificate is valid for 5 years. Re-registration planning should begin in advance to ensure updated documents, certificates, labeling, and product information are ready before expiry.
For regulatory support, dossier preparation, labeling review, translation coordination, and market access planning in Azerbaijan, please contact:
