Medical Device Registration in Azerbaijan

Medical Device Registration in Azerbaijan

Medical Device Registration in Azerbaijan

Makromed MMC provides professional regulatory services for manufacturers, distributors, importers and local representatives seeking state registration of medical devices in Azerbaijan, including renewal and registration variation procedures.

Medical devices may include medical equipment, instruments, devices, implants, diagnostic materials, laboratory products, sterile and non-sterile medical products, dressing materials and other healthcare products intended for diagnosis, treatment, prevention, monitoring, rehabilitation or performance of medical procedures.

In Azerbaijan, medical device circulation is assessed based on the intended use of the product, risk class, technical characteristics and compliance of the submitted documentation with national regulatory requirements. Medical devices with medium, high and higher risk classification are subject to state registration.

Makromed MMC supports clients throughout the entire process: from initial assessment of the product and review of manufacturer documents to preparation of the registration dossier, communication with the competent authority, response to expert queries and receipt of the registration certificate.

Our services include:

• initial regulatory and technical assessment of the medical device;
• classification of the product as a medical device;
• preliminary assessment of the risk class;
• review of manufacturer documentation;
• assessment of CE certificate, ISO 13485 certificate, declaration of conformity and free sale certificate;
• preparation of the product’s intended use, scope of application and technical description;
• adaptation of labelling, packaging and instructions for use to Azerbaijani requirements;
• document review for sterile, implantable, active, diagnostic and other special categories of medical devices;
• assessment of additional requirements for combined products or devices containing medicinal substances;
• preparation of documents for registration, renewal and variation procedures;
• communication support with the Analytical Expertise Center;
• preparation of responses to expert queries;
• post-registration support and variation management.

Documents that may be required for registration:

• manufacturer information;
• document confirming the manufacturer’s right to manufacture the product;
• ISO 13485 or other quality management system certificate;
• CE certificate and declaration of conformity;
• free sale certificate or export certificate;
• technical description of the device;
• instructions for use;
• labelling and packaging mock-ups;
• sterilization and validation documents for sterile devices;
• biological safety, clinical evaluation and risk management documents;
• storage and transportation conditions;
• manufacturer authorization letter and other supporting documents.

Why choose Makromed MMC?

Medical device registration requires correct product classification, proper risk class assessment, complete dossier preparation and professional communication during the expert review process.

Incomplete documentation, incorrect labelling, inaccurate intended use description or insufficient technical information may lead to additional queries and delays. Makromed MMC assesses these risks in advance and helps clients manage the registration process in a structured, transparent and compliant manner.

Makromed MMC has practical experience in medical device registration, pharmaceutical registration, pharmacovigilance, import procedures and local representative services. We support foreign manufacturers and local distributors in entering the Azerbaijani market in compliance with national regulatory requirements.

For professional support with medical device registration, dossier preparation and regulatory procedures in Azerbaijan, you may contact Makromed MMC.