Tajikistan Medical Software and Measuring Instruments: Regulatory Treatment

1. Key takeaways

Tajikistan applies a cross-jurisdictional mechanism to medical equipment that constitutes measuring instruments. Article 37(4) of Law No. 1893 provides that the list of medical equipment and instruments that are measuring instruments is approved by the authorized state body in the healthcare sector together with the authorized state body in the field of technical and metrological regulation. GRZAN notes two points: first, Law No. 1893 contains no separate statutory provisions on the regulation of medical software, and the status of software products depends on whether they fall within the definition of medical products in Article 1(11); second, any equipment on the measuring instrument list must satisfy both the medical device registration requirements and a parallel set of metrological supervision requirements.

2. Legal basis

3. Expert insights

Insight 1: Article 37(4) is a rare interdepartmental joint provision in the Tajik regulatory framework, pointing to the overlap of metrological supervision. The provision requires the Ministry of Health to approve the measuring instrument list together with the authorized state body in the field of technical and metrological regulation. The GRZAN interpretation is that any equipment on the list must satisfy two sets of specifications simultaneously, for technical testing under Article 33 and for subsequent maintenance under Article 37. For products with measurement functions, such as blood pressure monitors, infusion pumps, patient monitors, biochemical analyzers and thermometers, this is a compliance point that must be confirmed early.

Insight 2: Law No. 1893 has no independent software provisions, and the status of software depends on the interpretation of Article 1(11). A full-text search of the law finds no mention of software, programs or algorithms. Whether software can be registered as a medical product depends on whether it meets the definition of Article 1(11): articles and materials applied in medical practice for the diagnosis, treatment and prevention of diseases. The GRZAN judgment is that the legal status of standalone medical software (SaMD) in Tajikistan is unclear. In planning, companies should first register software together with the hardware as an integrated product; where the software requires separate registration, they should obtain written confirmation from the Ministry of Health in advance on whether it falls within the scope of medical products.

Insight 3: Article 37(2) sets a clear and strict standard for equipment products. The provision states that the safety level of medical equipment after repair must not be lower than the safety level stated in the technical passport. The value of this clause is that it establishes the technical passport as the benchmark document for safety levels. For equipment containing software, software upgrades and parameter changes may affect the safety level, so software changes must also be evaluated against the benchmark of the technical passport. GRZAN recommends incorporating software version management into the technical passport system.

Insight 4: Article 37(1) assigns the qualifications for installation, repair and technical-metrological maintenance to persons and legal entities authorized under the legislation. The provision does not enumerate the qualification requirements but points to Tajik legislation. The GRZAN practical recommendation is that, when Chinese manufacturers conclude after-sales agreements with local service providers, they verify that the provider holds the relevant qualifications and expressly include the non-degradation obligation of Article 37(2) in the agreement.

Insight 5: The other relevant bodies mentioned in Article 33(3) find their echo in this article. Article 33(3) provides that technical testing within institutions is carried out under procedures determined by the Ministry of Health and other relevant bodies, and Article 37(4) clarifies that one of those other relevant bodies is the authorized state body in the field of technical and metrological regulation. The correspondence between the two provisions confirms that the metrology authority is a standing participant in the Tajik technical regulation system for devices.

4. Practical recommendations

1. Confirm at project initiation whether the product is on the measuring instrument list. Under Article 37(4), request the current list of medical equipment that are measuring instruments from the Ministry of Health and check model by model. For listed products, prepare metrological verification materials in parallel.
2. Connect measurement-function products to metrological requirements simultaneously. For blood pressure monitors, infusion pumps, patient monitors, biochemical analyzers, thermometers and similar products, arrange metrological verification during the technical testing stage to avoid two separate submissions.
3. Register software together with the hardware as the priority, and obtain written confirmation before standalone registration. Under Article 1(11), the status of software depends on the interpretation of the definition. Register with the hardware first; where separate registration is genuinely needed, first confirm in writing with the Ministry of Health whether the software falls within the scope of medical products.
4. Incorporate software version management into the technical passport system. Under Article 37(2), the safety level after repair must not fall below the level stated in the technical passport. Include software versions and parameter configurations in the technical passport and assess the safety impact of every upgrade in advance.
5. Implement the obligations of Article 37(2) in after-sales agreements. In agreements between Chinese manufacturers and local service providers, expressly require the provider to hold the relevant qualifications and commit that the safety level after repair will not fall below the level stated in the technical passport.

5. Verification checklist

• □ The current list of medical equipment that are measuring instruments has been requested from the Ministry of Health and checked model by model (Article 37(4))
• □ Metrological verification materials have been prepared in parallel for listed products
• □ The registration pathway for software products (with hardware or standalone) has been confirmed, with written Ministry of Health confirmation obtained where necessary
• □ Software versions and parameter configurations have been incorporated into the technical passport management (Article 37(2))
• □ Provider qualifications and the non-degradation safety obligation have been implemented in after-sales agreements (Article 37(1) and (2))
• □ It has been confirmed that technical testing must satisfy the procedures of both the Ministry of Health and the metrology authority (Article 33(3))
• □ The intended-use benchmark of Article 33(2) has been confirmed to be consistent with the technical passport

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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