Tajikistan Medical Device Registration Fees and Statutory Exemptions: What the Law Actually Says

1. Key takeaways

The registration fee system of Tajikistan can be summarised in three sentences. The fee standards for conformity assessment services are established and approved by the authorised state body in the field of health together with the authorised state body in the field of antimonopoly policy (Article 13(2)). The fee standards for quality certificates and expert assessment services are approved by the supervisory authority together with the antimonopoly authority (Article 9(4)). The only exemption expressly provided by law is Article 17(11): medicines used for the diagnosis and treatment of rare diseases, and medicines and medical devices imported into the Republic of Tajikistan as humanitarian aid and used for the implementation of state health programmes, are exempt from registration fees. GRZAN notes that any specific amounts circulating in public sources – application fees, technical assessment fees, sample testing fees, registration certificate fees and the like – are marked by us as practical estimates, subject to the payment notice, and are not used as compliance references.

2. Legal basis

3. Expert insights

Insight 1: The common feature of Article 13(2) and Article 9(4) is the participation of the antimonopoly authority in price setting. The two provisions address conformity assessment services and quality certificate and expert assessment services respectively, but both require joint approval with the authorised state body in the field of antimonopoly policy. The purpose of this design is to prevent the pricing of mandatory services with a monopolistic character from becoming uncontrollable. The practical consequence for companies is that both categories of fees have statutory pricing documents, and companies are entitled to request the formal fee basis; unsupported verbal quotations should not be accepted.

Insight 2: Article 17(11) is the only provision of law that can be cited in the Tajik registration fee system. When GRZAN reviews any external statement about Tajik registration fees, only Article 17(11) is retained as the statutory basis. All other figures – whether from consulting firms, industry websites or past experience – are marked as practical estimates. The principle behind this treatment is that the law identifies who sets the prices but does not state the amounts; where no amount appears in a legal basis, there is no statutory figure that can be cited.

Insight 3: Of the two exempted categories in Article 17(11), only the second is available to medical devices. The first category covers medicines used for the diagnosis and treatment of rare diseases, and the wording of the provision refers to medicines. The second category covers medicines and medical devices imported as humanitarian aid and used for the implementation of state health programmes, and expressly includes medical devices. GRZAN notes that device companies can pursue the fee exemption only through the humanitarian aid pathway; the rare disease pathway does not apply to devices on the face of the text.

Insight 4: Registration fees and conformity assessment service fees are two different payments. Article 17(11) exempts the registration fees; Article 13(2) and Article 9(4) govern the service fees for conformity assessment and quality certificates. The two differ in nature and are collected at different stages. Even where the exemption of Article 17(11) is obtained, conformity assessment and quality certificate service fees may still arise. Companies should list these items separately in their cost calculations.

Insight 5: The simplified pathway of Article 17(9) and the fee exemption of Article 17(11) are two independent benefit lines. The simplified pathway addresses acceleration of the procedure; the fee exemption addresses relief from payment. Their applicable situations differ (emergencies for the former; rare diseases and humanitarian aid for the latter), and so do their legal effects. When assessing cost and timeline, companies should evaluate and apply for the two separately.

4. Practical recommendations

1. List Article 17(11) as the only statutory exemption in the fee template. GRZAN recommends that the internal cost estimation sheet list this provision separately as the statutory exemption item, with all other figures marked as practical estimates, subject to the payment notice.
2. Request the formal fee basis and compare it item by item. Under Article 13(2) and Article 9(4), require the executing agency to issue the fee basis documents, compare them with the internal budget item by item, and refuse unsupported verbal quotations.
3. Pursue the fee exemption for devices through the humanitarian aid pathway. Under the second category of Article 17(11), prepare the aid documents, the evidence linking the supplies to a state health programme, and the goods list in advance.
4. Present the cost estimate by item, not as a blended figure. List registration fees, conformity assessment service fees, quality certificate fees, expert assessment fees, translation and notarisation fees, and local agent fees as separate items, so that payments of different nature are not confused.
5. Assess the simplified pathway and the fee exemption separately. In the project evaluation sheet, set Article 17(9) (simplified pathway) and Article 17(11) (fee exemption) as two independent fields and record the applicable basis for each.

5. Verification checklist

• □ Confirmed that Article 17(11) is the only registration fee exemption provision with a legal source in Tajikistan
• □ Listed Article 17(11) as the only statutory exemption in the fee template, with all other figures marked as practical estimates
• □ Obtained the formal fee basis for conformity assessment and quality certificate services (Article 13(2), Article 9(4))
• □ Confirmed that devices can pursue the fee exemption only through the second category of Article 17(11) (humanitarian aid)
• □ Listed the budget by item: registration fees, assessment fees, certificate fees, expert assessment fees, translation and notarisation fees, agent fees
• □ Distinguished the two benefit lines of Article 17(9) and Article 17(11) in the project evaluation sheet
• □ Prepared the humanitarian aid documents and the evidence linking supplies to a state health programme (where applicable)

Regulatory information verified as of October 29, 2026.

In the Central Asian market, the core capabilities of GRZAN focus on three points. First, distinguishing the different legal positions of each market within the Eurasian Economic Union: Kazakhstan and Kyrgyzstan are full member states where a choice exists between a national pathway and a Union pathway; Uzbekistan is an observer state with only a national pathway; Tajikistan and Turkmenistan are outside the Union framework and must follow purely national procedures. Second, local authorised representative services: GRZAN can act as the statutory representative of manufacturers in the above countries, undertaking registration submission, regulatory communication and post-market reporting obligations. Third, quality system and testing support: GRZAN assists in establishing a quality management system conforming to ISO 13485 and connects clients with locally accredited laboratory resources.

For business inquiries: info@grzanglobal.com