Azerbaijan Medical Device Changes: Two Routes Between Certificate Reissue and Correction

1. Key takeaways

There are two routes for the registration of changes to a device:

Route one (paragraph 7.2) — where any information contained in the certificate changes, a new certificate is produced retaining the registration number; it is issued in the format of Annex 6 within 7 working days of the applicant’s filing with the Ministry of Health (for devices under paragraph 4.4, within 7 working days of submission of the expert assessment opinion); the new certificate records the date of the registered change of national registration; and the validity of the new certificate is limited by the validity of the previous certificate.

Route two (paragraph 7.7) — corrections (düzəlişlər) to registration documents other than the information contained in the Annex 5 and Annex 6 certificates undergo state registration without producing a new certificate.

The test is very clear: look at whether the changed information is printed on the certificate. The fields of Annex 5 include: the certificate holder, the manufacturer and its country, the manufacturer’s address, the trade name of the device, accessories, the risk class of the device, the type of device, the GMDN code, information on the legal entity and its tax identification number, the name and address of the issuing authority, the register number of the device, and the registration date and validity period.

2. Legal basis

• Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 345 of July 18, 2024, on the Rules for the National Registration of Medicinal Products, Pharmacologically Active Substances and Medical Devices, Their Inclusion in the State Register and the Maintenance of the State Register (entered into force on July 19, 2024; Xalq qəzeti, July 20, 2024, No. 151; Collection of Legislation, 2024, No. 7, Article 906; repealed Resolution No. 108 of July 13, 2007, with effect from July 20, 2024): paragraph 7.2 (changes to certificate information lead to a new certificate, retention of the number, 7 working days, Annex 6, validity limited by the previous certificate), paragraph 7.7 (changes not affecting certificate information do not lead to a new certificate), paragraph 7.1 (first issuance, Annex 5), Annex 5 (fields of the device certificate), Annex 6 (fields of the certificate for registered changes), second sentence of paragraph 7.8 (filing within 7 working days), paragraph 6.14 (duplicate issued for a lost or damaged certificate free of charge).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında, Law of the Republic of Azerbaijan No. 208-IIIQ, adopted on December 22, 2006, entered into force on February 28, 2007, Collection of Legislation of the Republic of Azerbaijan, 2007, No. 2, Article 70), as amended by Law No. 979-VIQD of July 14, 2023 (which added Articles 1-1 and 9-1 as new provisions, Collection of Legislation, 2023, No. 8, Article 1127): Article 6.10 (registration of changes is subject to the state duty), Article 6.12 (sell-off of products placed into circulation during the validity period).
• Law of the Republic of Azerbaijan on Administrative Procedure, Article 31 (acceptance and registration of applications).

3. Expert insights

Insight 1: The final sentence of paragraph 7.2 is the most frequently overlooked cost item in change management. The validity of the new certificate is limited by the validity of the previous certificate — a new certificate issued in change registration does not reset the 5-year cycle. A company that treats a change as an opportunity to renew the certificate along the way will discover at the next re-registration that the window arrives much earlier than expected.

Insight 2: Annex 6 adds the field for pharmacologically active substances compared with Annex 5, indicating that the change certificate leans toward devices containing such substances. Annex 6, the certificate for registered changes, adds to the Annex 5 fields the API (international nonproprietary name and dosage), excipients, dosage form, standard packaging and the new registration date. This design mainly addresses changes to devices containing pharmacologically active substances under paragraph 4.4 — such changes must first undergo expert assessment by the AEC (paragraph 4.4).

Insight 3: The corrections route under paragraph 7.7 gives low-risk changes a low-cost path. The wording used is düzəlişlər (corrections, amendments), limited to corrections that do not change the information contained in the certificate. Typical scenarios: refinement of internal technical parameters in the dossier, updated versions of test reports, and documentation revisions that do not affect the labelling or the instructions for use. Such changes involve no new certificate and no change to public fields, so the cost is the lowest.

Insight 4: The duplicate rule in paragraph 6.14 is a separate matter from changes. Where a certificate is lost or damaged, a duplicate is issued at the request of the certificate holder, marked as a duplicate, without charging the state duty; the damaged certificate must be returned to the Ministry of Health. This is not a change and does not create a new validity period. Devices apply paragraph 7.11, which refers to paragraph 6.14.

Insight 5: Both routes go through the state registration procedure; they are not mere notifications. Paragraphs 1.5 and 1.6 determine the legal nature of a change as state registration, handled by the Ministry of Health and entered in the register. Paragraph 7.7 only waives the act of producing a new certificate; it does not waive the state registration procedure or the state duty under Article 6.10 (practical estimate: whether a fee applies in the paragraph 7.7 scenario should be confirmed in writing with the AEC).

4. Practical recommendations

1. Before any change, compare against the fields of Annex 5 to select the route: if a certificate field is affected, follow paragraph 7.2 (new certificate); if not, follow paragraph 7.7 (no new certificate).
2. Schedule the paragraph 7.2 route on the basis of 7 working days (for devices under paragraph 4.4, counted from submission of the expert assessment opinion), and respect the 5-working-day payment window.
3. Do not treat change registration as resetting the 5-year cycle; schedule re-registration separately under paragraph 7.8.
4. For devices containing pharmacologically active substances, prepare the API, excipient, dosage form and standard packaging fields in Annex 6 and reserve time for the AEC expert assessment.
5. Handle a lost or damaged certificate through the duplicate procedure of paragraph 6.14 (free of charge, damaged certificate to be returned), not as a change.
6. Confirm in writing with the AEC whether the state duty applies in the paragraph 7.7 scenario, and keep the reply on file.

5. Verification checklist

• □ The route for each change has been determined by comparison with the fields of Annex 5 (paragraph 7.2 or paragraph 7.7).
• □ The paragraph 7.2 route has been scheduled on 7 working days with a reserved payment window.
• □ The internal position that change registration does not reset the 5-year cycle has been documented.
• □ The additional Annex 6 fields for devices containing pharmacologically active substances have been prepared.
• □ Lost or damaged certificates have been handled through the duplicate procedure of paragraph 6.14.
• □ The fee treatment of the paragraph 7.7 scenario has been confirmed in writing with the AEC.

Regulatory information verified as of October 30, 2026.

This article was prepared and translated by GRZAN as part of the international medical device registration guide. For professional support with regulatory submissions in Azerbaijan and other jurisdictions, contact info@grzanglobal.com.