Tajikistan Medical Device Import and Export: Eligible Entities, Permits and Authorised Persons

1. Key takeaways

Tajikistan places two gates in front of the import and export of medicines and medical devices: a subject gate – only three categories of entities may engage in the activity; and a licence gate – a licence for foreign trade activity must be obtained. Article 26(1) of Law No. 1893 provides that the importation of medicines and medical devices into the territory of Tajikistan and their exportation from the territory are carried out by individual entrepreneurs or legal entities in accordance with the procedure determined by the legislation of the Republic of Tajikistan, upon obtaining a licence for foreign trade activity; Article 26(3) lists 3 categories of entitled subjects. GRZAN notes that Article 26(2) expressly provides that medicines and medical devices that have not undergone state registration are prohibited from import and export, except in the situations provided by paragraphs 7 and 8 of the same article.

2. Legal basis

3. Expert insights

Insight 1: Article 26(1) takes the individual entrepreneur or legal entity as the subject basis and adds the licence requirement for foreign trade activity. The provision requires two elements to be satisfied at the same time: the form of the subject (an individual entrepreneur or a legal entity) and the licence (a licence for foreign trade activity). GRZAN reads this as follows: a foreign manufacturer cannot itself act directly as the importing party; it must work through a local wholesale entity falling under Article 26(3)(1), or handle import and export for registration purposes in its own name under paragraph 3(3).

Insight 2: Article 26(3)(3) is the most important channel for foreign manufacturers. The provision lists foreign manufacturers of medicines and medical devices and their authorised persons as entitled subjects, with the purposes expressly enumerated as expert review, state registration, clinical trials and participation in scientific and political events. The value of this provision is that samples, trial supplies and review materials for the registration stage can be lawfully imported and are not subject to the registration-first restriction of Article 26(2) (in combination with Article 26(8)(4) and (5)). GRZAN recommends using this provision as the primary basis for sample importation during the registration stage.

Insight 3: The import ban of Article 26(6) covers three categories, and the expiry of the validity period has direct significance for devices. The provision prohibits the importation of counterfeit medicines, medicines that do not meet the established requirements, and medicines and medical devices whose validity period has expired. For sterile devices, in vitro diagnostic reagents and other products with a shelf life, the validity period is a hard gate at the import stage. Read together with Article 24(2) (the remaining shelf life threshold for humanitarian aid supplies), it is clear that Tajikistan applies multi-layered control over validity period issues.

Insight 4: Article 26(4) establishes an information flow between customs and the supervisory authority. The provision requires customs to inform the supervisory authority of import and export operations. The implication is that every import and export transaction is within the view of the regulator; batch quality certificates (Article 13(1)) and registration status (the register under Article 17(8)) will be cross-checked. GRZAN recommends that companies perform a full document reconciliation before every shipment, ensuring that the certificate, the batch certificate and the validity period are mutually consistent.

Insight 5: Article 26(5) assigns the import and export procedure to the Government, which forms a different level from Article 17(12) (registration procedures assigned to the Ministry of Health). Registration procedures follow the Ministry of Health; import and export procedures follow the Government. GRZAN keeps these two levels separate when tracking regulatory updates: Government resolutions are tracked for import, export and pricing matters, while Ministry of Health documents are tracked for registration and technical requirements.

4. Practical recommendations

1. Verify the qualification and licence of the importing party. Under Article 26(1) and paragraph 3(1), confirm that the local partner is an individual entrepreneur or legal entity lawfully engaged in wholesale production and sale, and holds a licence for foreign trade activity.
2. Route registration-stage samples through Article 26(3)(3). Arrange sample importation in the name of the foreign manufacturer or its authorised person, for the purposes enumerated in that paragraph, and invoke the exemptions of Article 26(8)(4) and (5) at the same time.
3. Perform a three-item reconciliation before every shipment: certificate, batch, validity. Check that the registration certificate is valid (Article 17(6)), the batch quality certificate is complete (Article 13(1)), and the validity period has not expired (Article 26(6)).
4. Set up a validity period alert for products with a shelf life. For sterile devices and in vitro diagnostic reagents, configure an alert in the logistics system and work backwards from the transport cycle to the latest shipping date.
5. Track Government resolutions and Ministry of Health documents at separate levels. Maintain two tracking lines: the Government resolution line for the import and export procedures of Article 26(5) and the price controls of Article 28; the Ministry of Health line for the registration procedures and technical requirements of Article 17(12).

5. Verification checklist

• □ Confirmed that the importing party is an individual entrepreneur or legal entity (Article 26(1))
• □ Verified that the importing party holds a licence for foreign trade activity
• □ Confirmed that the importing party belongs to one of the three entitled categories listed in Article 26(3)
• □ Enabled the paragraph 3(3) channel for registration-stage samples and invoked the exemptions of paragraph 8(4) and (5)
• □ Completed the three-item reconciliation of registration certificate, batch quality certificate and validity period before every shipment
• □ Set up a validity period alert and a latest shipping date for products with a shelf life
• □ Established two tracking lines: Government resolutions (import, export, prices) and Ministry of Health documents (registration, technical)

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.

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