EAEU Medical Device Rules and Turkmenistan: Why Decisions 78 and 34 Do Not Apply

1. Key takeaways

Two developments in EAEU device rules in recent years deserve attention:

• Decision No. 78 of the Board of the Eurasian Economic Commission (adopted November 3, 2016, amended in 2025), which added, among other things, Section XV;
• Decision No. 34 of the Board of the Eurasian Economic Commission (adopted May 22, 2025, effective June 21, 2025), which introduced a three-category division for devices packaged together with medicines (Articles 187 and 187(1)).

The conclusion is direct: neither of the two applies to Turkmenistan, because Turkmenistan is not an EAEU member (Article 45 of this series). Within this series their role is comparison, not authority. The practical message for manufacturers is to keep two separate rulebooks: one for the EAEU member states in the regional portfolio, and one for Turkmenistan.

2. Legal basis

3. Expert insights

Insight 1: Why devote a segment to regulations that do not apply.

Because the cost of misapplying them is high. When companies plan across the Central Asian region, the easiest error is to treat new EAEU rules as a common regional trend. Preparing Turkmen documentation according to the three-category division of Decision No. 34 would produce a classification argumentation that the competent authority never asked for, consuming budget and time without any regulatory benefit. The error is compounded by timing: regional plans built on EAEU milestones create internal deadlines that have no legal meaning in Turkmenistan, and correcting them mid-project is costly.

Insight 2: The three-category division of Decision No. 34 solves a problem specific to the EAEU.

That decision addresses the classification of products packaged together with medicines, which in the EAEU is a genuine boundary question because medicines and devices fall under two separate sets of rules. Turkmenistan does not have this problem at all: devices and medicines are regulated within one law and one system (Articles 01 and 02 of this series). Where the institutional premises differ, the rules naturally differ. The same applies in reverse: Turkmen requirements, such as the national dossier format, are not replaced by any EAEU submission already made.

Insight 3: Viewed in reverse, this non-applicability also reveals a feature of the Turkmen rules.

Because devices and medicines share one system, Turkmenistan does not need to draw a dedicated boundary between what is a medicine and what is a device in the EAEU manner. For combination product companies this is in fact a simplification: no argumentation cost needs to be invested in classification, and the dossier can focus on the safety, quality and effectiveness evidence of the product itself. This structural simplification should be stated in the regulatory strategy document, so that teams do not import combination-product classification work by habit.

Insight 4: The 2025 amendment of Decision No. 78 reflects the continuing evolution of EAEU rules.

Amendments of this kind update documentation requirements within EAEU member states. For companies active in Turkmenistan, the correct response is to watch without following: watching, because such amendments may indicate regional trends; not following, because the amended rules carry no legal force in Turkmenistan. A quarterly review of EAEU developments is sufficient for this purpose; deeper analysis is only warranted if a customer market inside the union becomes relevant.

Insight 5: What actually needs to be tracked in Turkmenistan is the domestic agenda.

The items worth tracking in this market are announcements of the Ministry of Health and its national center, amendments to the national registration regulation, and the advance of digital government services (Article 47 of this series). These are the variables that genuinely affect documentation and procedure, and they should occupy the monitoring resources that would otherwise be spent on regional noise. Assigning this monitoring to the local representative, who reads the announcements in the working language, keeps the effort modest and the output actionable.

4. Practical recommendations

1. Read the EAEU rules for comparison only, never as the documentary basis for Turkmenistan.
2. Do not prepare classification argumentation for Turkmenistan using the EAEU three-category division.
3. Combination products can exploit the single system for medicines and devices to reduce classification argumentation.
4. Track domestic announcements and regulation amendments in Turkmenistan, which are the effective variables.
5. List the applicable rules separately for each Central Asian country in regional planning to avoid mixing them.

5. Verification checklist

• □ EAEU rules have been marked as for comparison purposes.
• □ The Turkmen documentation does not apply the EAEU three-category division.
• □ The scope for simplified classification argumentation for combination products has been assessed.
• □ A mechanism for tracking domestic developments has been established.
• □ Separate rule lists have been drawn up for each Central Asian country.

Regulatory information verified as of October 30, 2026. The EAEU instruments cited in this document are Decision No. 78 of the Board of the Eurasian Economic Commission (adopted November 3, 2016, amended in 2025) and Decision No. 34 (adopted May 22, 2025, effective June 21, 2025, Articles 187 and 187(1)). Both apply only to EAEU member states; Turkmenistan is not a member, so they are not applicable and are cited here expressly for comparison. The domestic basis in Turkmenistan is the Law on the Supply of Medicines No. 319-V (January 12, 2016).

• Local resources in Turkmenistan: GRZAN can coordinate licensed local import entities and authorized representative resources, covering state registration submission, the consular legalization chain for documents, sample delivery, coordination with mandatory TDS certification and customs clearance support.
• Service capabilities: classification determination, registration pathway selection, dossier preparation in the national format, consular legalization and notarization, test and stability documentation, GMP and ISO 13485 evidence organization, variations and re-registration, vigilance and post-market maintenance.
• Contact: info@grzanglobal.com. GRZAN provides registration support in this country for manufacturers, importers and authorized representatives.