Tajikistan Twelve Grounds for Withdrawal from Circulation: Medical Device Risk Map

1. Key takeaways

The power to withdraw products from circulation in Tajikistan is exercised by the State Supervisory Authority for Pharmaceutical Activity, and the triggering grounds are prescribed by Article 21(1) in the form of a closed list of 12 items. GRZAN points out the two items most relevant to medical devices: item 12 is the only ground designed specifically for medical products — defects in structure, principle of action or manufacturing that affect the safety of use discovered during the use of a medical product; item 3 draws the line at the moment of import — where the registration and re-registration periods expired before the product was brought into Tajikistan, this constitutes a withdrawal ground. The implication of this timing design is that stock for which re-registration was not completed in time, even if lawful abroad, will be withdrawn from circulation once it enters Tajikistan.

2. Legal basis

3. Expert insights

Insight 1: item 12 is the only provision among the twelve grounds that targets medical products specifically. Its wording covers defects discovered during the use of a medical product in structure, principle of action and manufacturing that affect the safety of use. These three dimensions of defect — structure, principle of action and manufacturing — cover exactly the three sources of device risk: design risk, principle risk and manufacturing risk. This provision is close in approach to the defect definition in the Chinese measures on medical device recall, which makes it easier for companies to align with their existing systems.

Insight 2: item 3 takes the moment before entry into Tajikistan as the reference point, creating an independent risk at the import stage. The ground provides that expired registration and re-registration periods before import constitute a withdrawal ground. The GRZAN approach is to bind the re-registration schedule to the logistics schedule, ensuring that the registration status is valid when the goods arrive, rather than merely watching the validity of the certificate itself.

Insight 3: items 6 and 7 link with Article 20 to form an approved-instructions baseline. Item 6 targets harmful adverse reactions not stated in the instructions for use, while item 7 targets an increase in cases of serious adverse reactions already stated in the instructions. Together they set the approved instructions for use as the reference baseline for safety: the instructions are both the scope committed at registration and the criterion for post-market withdrawal.

Insight 4: item 8 converts foreign regulatory actions into a local withdrawal ground. The ground is triggered by receipt of information from other countries that medicines and medical products have been prohibited or withdrawn due to the detection of serious adverse reactions. This means that a withdrawal decision in any single market can be transmitted to Tajikistan, and companies must manage safety information on a global basis.

Insight 5: item 4 lists the voluntary application of the certificate holder as a statutory ground. An application by the registration certificate holder for prohibition, cancellation or restriction of circulation and use itself constitutes a withdrawal ground. This design gives the holder a proactive disposal channel, making voluntary reporting preferable to passive enforcement.

Insight 6: Article 21(2) assigns the power to make the procedure to the Ministry of Health. The detailed operating procedure for withdrawal is developed and approved by the Ministry of Health, and companies must follow the most recently published procedure text of the Ministry rather than relying solely on inference from the statutory text.

4. Practical recommendations

1. Build a withdrawal risk self-check table based on the twelve grounds. Under Article 21(1), establish an internal self-check mechanism item by item; items 3, 5, 6, 7 and 12 are most relevant to devices.
2. Bind the re-registration schedule to the logistics schedule. Under Article 21(1)(3), ensure that the registration status is valid when goods are brought into Tajikistan.
3. Manage safety data against the approved instructions as baseline. Under items 6 and 7, maintain a comparison register between what the instructions state and what actually occurs.
4. Manage foreign withdrawal information on a global basis. Under item 8, any withdrawal decision in any market must trigger a local assessment.
5. Give priority to proactive disposal over passive enforcement. Under item 4, after a risk is confirmed, the registration certificate holder should proactively apply for restriction of circulation or cancellation.
6. Track the procedure text published by the Ministry of Health. Under Article 21(2), the withdrawal procedure follows the current rules of the Ministry of Health.

5. Verification checklist

• □ Confirmed that Article 21(1) lists twelve grounds for withdrawal from circulation
• □ Confirmed that the withdrawal power is exercised by the State Supervisory Authority for Pharmaceutical Activity
• □ Confirmed that item 12 is the only ground targeting medical products specifically (defects in structure, principle of action and manufacturing)
• □ Confirmed that item 3 takes the moment before entry into Tajikistan as the reference point
• □ Established an internal self-check table covering the twelve grounds
• □ Bound the re-registration schedule to the logistics schedule
• □ Established a comparison register between instructions for use and actual findings (items 6 and 7)
• □ Established a trigger mechanism for local assessment of foreign withdrawal information (item 8)
• □ Confirmed that the procedure under Article 21(2) is developed and approved by the Ministry of Health

Regulatory information verified as of October 29, 2026.

In the Central Asia market, the core capabilities of GRZAN concentrate on three points. First, distinguishing the different legal positions of individual markets within the Eurasian Economic Union — Kazakhstan and Kyrgyzstan are full member states, where a national pathway and a Union pathway both exist; Uzbekistan is an observer state with only a national pathway; Tajikistan and Turkmenistan lie outside the Union framework and must proceed entirely under national procedures. Second, local authorized representative services, which may act as the statutory representative of manufacturers in these countries and assume registration submissions, regulatory communication and post-market reporting obligations. Third, quality system and testing support, assisting in establishing a quality management system that meets ISO 13485 requirements and connecting with locally accredited laboratory resources.

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