Tajikistan Medical Device Installation, Repair and Metrological Maintenance

1. Key takeaways

Tajikistan imposes four requirements on the installation, repair, technical and metrological maintenance of medical products: the implementing entity must be authorized by law, the safety level after repair must not be lower than the level stated in the technical passport, the organization of servicing follows the legislation, and the list of measuring instruments is approved by the Ministry of Health together with the metrology authority. Article 37 of Law No. 1893 contains 4 paragraphs in total and is one of the few provisions in this medicines-centered law that specifically addresses the later stage of the equipment product life cycle. GRZAN notes that the technical passport in Article 37(2) is the key concept for understanding equipment compliance in Tajikistan: it serves both as the technical registration file and as the determination benchmark for the safety level after repair.

2. Legal basis

3. Expert insights

Insight 1: Article 37(2) establishes the technical passport as the benchmark document for safety levels, the core compliance concept for equipment products. The provision requires that the safety level after repair not be lower than the level stated in the technical passport. Its legal effect is that the safety level stated in the technical passport is a floor that can never be lowered; repair, modification and software upgrades may not reduce it. GRZAN recommends that, when compiling the technical passport, the safety level be broken down into verifiable specific indicators covering electrical safety, mechanical safety, radiation safety and software functional safety, rather than expressed in general terms.

Insight 2: Article 37(1) and Article 37(3) point the qualifications of implementing entities and service organizations to Tajik legislation. Both paragraphs use the formulation in accordance with the legislation of the Republic of Tajikistan without enumerating specific qualifications. The GRZAN interpretation is that service provider qualifications may involve several tiers of legislation, including the law on licensing and legislation in the field of technical regulation. When selecting a local service provider, companies should require the provider to present the relevant qualification documents and include a qualification maintenance obligation in the agreement.

Insight 3: Article 37 and Article 21(1)(12) form a complete risk chain. Article 21(1)(12) provides that where defects in design, operating principle or manufacture execution affecting the safety of use are discovered during the use of a medical product, the supervisory authority must withdraw it from circulation, while Article 37(2) requires that repair not reduce the safety level. Read together, the meaning is that improper repair that lowers the safety level may simultaneously trigger a violation of Article 37(2) and a withdrawal under Article 21. This risk chain imposes substantive requirements on the after-sales management of equipment products.

Insight 4: Article 47(3) assigns liability for damage caused by incorrect or unreasonable prescription or use to the healthcare institution or the medical worker. The relationship between this provision and Article 37 is as follows: Article 37 governs the installation, repair and metrology of the equipment itself, while Article 47(3) governs attribution in the use stage. The dividing line is clear: problems of equipment condition fall under Article 37, and problems of use behavior fall under Article 47. When handling adverse events, companies should make this distinction first and then determine the response pathway.

Insight 5: Article 37 is the only provision in this volume covering the entire later life cycle, and its very existence shows the legislator considered the particularities of equipment. The overwhelming majority of the provisions of Law No. 1893, covering registration, review, labelling, advertising and withdrawal, apply uniformly to medicines and devices, whereas Article 37 specifically addresses installation, repair, technical and metrological maintenance, actions that are meaningful only for equipment. GRZAN recommends that, when designing a Tajik compliance program for equipment products, Article 37 be treated as a separate module covering installation acceptance, repair records, metrology cycles and service provider management.

4. Practical recommendations

1. Turn the technical passport into a verifiable list of indicators. Under Article 37(2), break the safety level down in the technical passport into verifiable indicators covering electrical safety, mechanical safety, radiation safety and software functional safety, providing a determination benchmark for subsequent repairs and inspections.
2. Include the qualification documents of local service providers in approved supplier reviews. Under Article 37(1) and (3), require providers to present qualifications obtained under Tajik legislation, and agree in the contract on qualification maintenance and notification obligations upon expiry.
3. Establish a repair record ledger and re-verify against the technical passport. Maintain repair records for each unit of equipment, and after every repair re-verify the safety indicators against the technical passport with a written conclusion, in preparation for inspections under Article 21(1)(12).
4. Incorporate metrology cycles into the equipment management system. Under Article 37(4), establish a metrological verification cycle ledger for equipment on the measuring instrument list with automatic reminders before expiry, avoiding expired verification affecting use and inspections.
5. Distinguish equipment condition from use behavior first in adverse event handling. Under Article 37 and Article 47(3), determine whether the event originates from equipment condition (Article 37) or from use behavior (Article 47(3)) before fixing the response pathway and the attribution of responsibility.

5. Verification checklist

• □ It has been confirmed that the implementing entity under Article 37(1) must be authorized by law
• □ The safety level in the technical passport has been broken down into verifiable specific indicators (Article 37(2))
• □ Local service providers have presented qualification documents and maintenance obligations are agreed in the contract (Article 37(1) and (3))
• □ A repair record ledger for each unit of equipment has been established with re-verification against the technical passport
• □ A metrological verification cycle ledger has been established for equipment on the measuring instrument list (Article 37(4))
• □ The adverse event handling process distinguishes equipment condition from use behavior (Article 37, Article 47(3))
• □ The risk of improper repair triggering a withdrawal under Article 21(1)(12) has been assessed

Regulatory information verified as of October 29, 2026.

In the Central Asian market, GRZAN focuses its core capabilities on three areas. First, distinguishing the different legal positions of each market within the Eurasian Economic Union: Kazakhstan and Kyrgyzstan are full member states where a national track and a Union track coexist; Uzbekistan is an observer state with only the national track; Tajikistan and Turkmenistan lie outside the Union framework and must proceed entirely under national procedures. Second, local authorized representative services: GRZAN acts as the statutory representative of manufacturers in these countries, undertaking registration submission, regulatory communication and post-market reporting obligations. Third, quality system and testing support: GRZAN helps establish a quality management system compliant with ISO 13485 and connects clients with locally accredited laboratory resources.

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