Tajikistan Medical Device Expert Review: The Five-Criteria Evaluation Framework

1. Key takeaways

The expert review of medical devices in Tajikistan follows a five-dimension comprehensive evaluation standard: safety, quality, effectiveness, economic viability and risk. Article 18(1) of Law No. 1893 provides that the expert review of medicines, medical devices and parapharmaceuticals is conducted by the State Supervisory Authority for Pharmaceutical Activities in accordance with the Health Code, this law and other regulatory legal acts, on the basis of a comprehensive evaluation of these five aspects and on the basis of the submitted documents. Article 18(2) provides that the review requirements are established by the authorized state body in the field of health care. GRZAN judges that these five dimensions should become the skeleton of the registration dossier structure: when dossier chapters map one to one onto the review dimensions, the probability of deficiency letters drops noticeably, because reviewers can locate each dimension of evidence without requests for clarification.

2. Legal basis

3. Expert insights

Insight 1: the entry of economic viability into the review standard is the feature that most clearly separates Tajikistan from most markets. Article 18(1) places economic viability alongside safety, quality, effectiveness and risk. GRZAN reads this dimension against the national context: more than 90 percent of medicines and devices used in the country are imported, health spending accounts for roughly 7 percent of the state budget, and the health budget has grown at around 10 percent annually (this set of figures is a practical estimate used to explain policy orientation, not statutory data). For applicants the practical meaning is that the dossier must answer what the product means for the health economy of Tajikistan, not merely whether the product is safe and effective.

Insight 2: listing risk alongside safety shows that the review distinguishes inherent hazards from risk acceptability. Article 18(1) treats risk and safety as two independent dimensions. Safety addresses whether the product itself causes harm; risk addresses the combined evaluation of the probability of harm and the severity of its consequences. This reading is consistent with the classification by degree of use risk in Article 13(5) and with the acceptability of adverse biological influences in Article 33(1): the Tajik review framework is oriented toward risk acceptability rather than a simple pass-or-fail determination, so a dossier that quantifies residual risk and justifies its acceptance answers the framework directly.

Insight 3: Article 18(1) names the Health Code as the first basis of review. The provision refers to the Health Code of the Republic of Tajikistan, this law and other regulatory legal acts. The Health Code No. 1413 therefore stands above the review as one of its superior bases. GRZAN recommends that companies facing a review dispute cite the Health Code alongside Law No. 1893 and the Ministry of Health documents, because an argument anchored only in the lower-tier provisions is easier for the authority to set aside.

Insight 4: Article 8(17) opens a path for the recognition of foreign standards. The provision empowers the Ministry of Health to recognize, where necessary, the pharmacopoeias and quality standards for medicines and medical devices of other countries. For manufacturers, the meaning is that when national or international standards need to be reconciled with Tajik requirements, a recognition path led by the Ministry of Health exists. It is not automatic, however: it requires a case-by-case request supported by an equivalence argument, so the effort should be planned into the project timeline rather than assumed.

Insight 5: the confidentiality provision of Article 17(7) can be deployed during review. Review requires access to technical details, while Article 17(7) allows core information such as formulations or compositions to be recognized as confidential. Companies should mark clearly at submission which documents fall within the confidential scope and state which of the conditions of that paragraph is met, so that core information does not circulate beyond the reviewers who need it.

4. Practical recommendations

1. Restructure the registration dossier around the five dimensions. GRZAN recommends dividing the dossier into five main chapters covering safety, quality, effectiveness, economic viability and risk, with each chapter subdivided by evidence type, so reviewers can locate each dimension directly.
2. Prepare a standalone argument for the economic dimension. Include a cost comparison with existing treatment options in Tajikistan, cost per use, maintenance and training costs and an analysis of local accessibility, citing Tajik public data wherever available.
3. Draft the risk chapter in an acceptability structure. Follow the sequence of hazard identification, probability of occurrence, severity of consequences, risk control measures and acceptability of residual risk, keeping the wording consistent with Article 33(1).
4. Request recognition under Article 8(17) early when standards must be reconciled. Prepare a standards comparison document explaining the equivalence of the standards to be cited with the Tajik requirements, and submit it as a technical argument during review.
5. Mark confidential fields clearly at submission. Under Article 17(7), mark the confidential scope on the technical documents and state which condition of that paragraph is satisfied, so core information does not spread during review.

5. Verification checklist

• □ Confirmed the five-dimension review standard of Article 18(1)
• □ Restructured the registration dossier around the five dimensions
• □ Prepared a standalone argument for the economic dimension
• □ Drafted the risk chapter in an acceptability argument structure
• □ Obtained the review requirements document issued by the Ministry of Health under Article 18(2)
• □ Included the Health Code No. 1413 in the citation range under Article 18(1)
• □ Marked the confidential scope on the technical documents and stated the conditions of Article 17(7)

Regulatory information verified as of October 29, 2026.

In the Central Asian market, the core capabilities of GRZAN concentrate 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 dual-track choice exists between the national route and the Union route; Uzbekistan is an observer state with only a national route; Tajikistan and Turkmenistan sit outside the Union framework and must follow purely national procedures. Second, local authorized representative services: GRZAN acts as the statutory representative of manufacturers in these countries and undertakes registration submissions, regulatory communication and post-market reporting obligations. Third, quality system and testing support: GRZAN helps establish a quality management system conforming to ISO 13485 and connects clients with locally accredited laboratory resources.

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