Tajikistan Medical Device Imports: Thirteen Exempt Cases under Article 26(8)

1. Key takeaways

Tajik law enumerates thirteen situations in which import and export may take place without being subject to state registration. Article 26(8) of Law No. 1893 provides that a limited quantity of medicines and medical devices may be imported into and exported from the Republic of Tajikistan irrespective of their state registration, in the following situations. GRZAN makes two points. First, these thirteen exemptions must be used in combination with the nine registration-free situations of Article 17(4) – where registration itself is waived, the import still needs its own basis. Second, the key word of the exemption is a limited quantity; quantities exceeding what is reasonable do not enjoy the exemption.

2. Legal basis

3. Expert insights

Insight 1: Item 5, together with Article 17(4)(9) and Article 26(3)(3), forms a complete registration sample channel. Article 26(8)(5) allows importation for the purpose of expert review, registration, re-registration and changes to the submitted documents; Article 17(4)(9) lists such samples among the situations exempt from state registration; Article 26(3)(3) lists foreign manufacturers and their authorised persons as entitled subjects. Taken together, the three provisions form the complete legal basis for sample importation during the registration stage. GRZAN recommends citing the three provisions as a group; none of them is sufficient alone.

Insight 2: Item 10 is the dedicated clause for equipment products, and its practical value is often underestimated. The provision allows the import and export of medicines and medical devices that serve as an integral part of medical equipment and devices and are not used directly or independently for medical or pharmaceutical purposes. The typical scenario is that calibrators, quality control materials, reagents and consumables supplied with an instrument may be imported together with the main unit without separate registration, provided they do not constitute an independently used product. This is an important channel for items accompanying large equipment, but two conditions must be met: the item must be inseparable from the equipment, and it must not be used independently.

Insight 3: Item 6 corresponds strictly to Article 17(4)(7). Item 6 is worded as display at exhibitions, trade fairs and conferences without the right of sale; Article 17(4)(7) refers to samples of medicines and medical devices used for exhibition without the right of further sale. Both emphasise the absence of any right of sale. GRZAN notes that giving samples away after the event, reselling them, or leaving them with a local institution would void the exemption and could trigger the withdrawal from circulation for unregistered products under Article 21(1)(1).

Insight 4: Items 1 and 13 cover inbound personal use and outbound personal use respectively – opposite directions. Item 1 covers personal use of natural persons arriving in the Republic of Tajikistan; item 13 covers export by natural persons of the necessary quantity for personal use. Together the two items confirm that articles for personal use are not subject to registration. GRZAN notes that the subject of both items is the natural person; a company cannot claim their application on the ground that the product is ultimately used by individuals.

Insight 5: Item 9, together with Article 26(7) and Article 17(9), forms the emergency situation channel. Item 9 allows importation for the prevention and elimination of emergency situations; Article 26(7) allows the Ministry of Health to permit a one-time importation of unregistered products in the event of natural disasters and emergencies, including infectious disease epidemics; Article 17(9) provides for simplified state registration. Together the three provisions cover both importation and registration during emergencies. GRZAN recommends preparing the three as a group in humanitarian and emergency projects.

4. Practical recommendations

1. Cite all three bases together when importing registration samples. Under Article 26(8)(5), Article 17(4)(9) and Article 26(3)(3), cite all three provisions simultaneously in the sample importation documents to form a complete chain of basis.
2. Assess the applicability of item 10 to items supplied with equipment. For calibrators, quality control materials, reagents and consumables imported with the main unit, assess whether the two conditions of inseparability and no independent use are met; if so, state this in the importation documents and invoke item 10.
3. Keep a full audit trail for exhibition samples. Under item 6 and Article 17(4)(7), maintain inbound and outbound inventory records and final disposal records demonstrating that there is no right of sale, avoiding the withdrawal ground of Article 21(1)(1).
4. Do not claim items 1 or 13 on the ground of ultimate personal use. The subject of these two items is the natural person; corporate importation does not qualify. Make this boundary explicit in internal training.
5. Prepare the three bases as a package for emergency projects. Under Article 26(8)(9), Article 26(7) and Article 17(9), prepare the import documentation, the one-time importation permit and the simplified registration application in parallel in humanitarian and emergency projects.

5. Verification checklist

• □ Compared the thirteen exemption situations of Article 26(8) item by item
• □ Cited Article 26(8)(5), Article 17(4)(9) and Article 26(3)(3) together in the registration sample importation documents
• □ Assessed whether items supplied with equipment meet the conditions of inseparability and no independent use under item 10
• □ Built inbound and outbound inventory records and final disposal records for exhibition samples (item 6, Article 17(4)(7))
• □ Confirmed that items 1 and 13 are not claimed on the ground of ultimate personal use
• □ Prepared the three bases of Article 26(8)(9), Article 26(7) and Article 17(9) in parallel for emergency projects
• □ Confirmed that exempted quantities are limited quantities and retained a justification of quantity reasonableness

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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