Armenia Medical Device Registration: QMS Production Inspections under EAEU Decision 43 of 2026

1. Key takeaways

The mandatory threshold for quality management system production inspections is the risk class: Class 2a sterile, Class 2b and Class 3 devices are subject to mandatory inspection, while Class 1 and Class 2a non-sterile devices may apply voluntarily. The judgment of GRZAN: Decision No. 43 of April 27, 2026, published 2026-05-19 and effective 2026-06-18, is the most substantive Union-level amendment of this cycle and introduces four changes, namely equal procedural standing for the authorized representative, a hard cap of 90 working days on inspection duration, an advance filing requirement of 90 working days for periodic inspections, and the sharing of sterilization facility inspection results across manufacturers.

2. Legal basis

3. Expert insights

Insight 1: the types and frequency of inspections are fixed by Articles 30 to 35 of Decision No. 106. Article 30 provides that the quality management system is assessed through an initial production inspection, a periodic planned production inspection and an unscheduled production inspection. Article 31 provides that the initial production inspection is conducted within the Union registration procedure for medical devices and that the inspection organization must inspect all manufacturing sites declared by the manufacturer. Article 33 provides that the report of the initial production inspection is valid for 3 years from its issuance. Article 34 provides that inspection results extend across a product group or subgroup, with groups applying to Class 1 and Class 2a and subgroups applying to Class 2b and Class 3. Article 35 provides that a periodic planned production inspection takes place every 3 years and that the manufacturer may approach any inspection organization within 6 months before the expiry of the previous inspection report. GRZAN points out that the 6-month window of Article 35 and the newly added 90-working-day rule are two different measures: the former marks the earliest point from which an application may be filed, while the latter is both the latest advance filing deadline and the maximum duration of the inspection; scheduling should follow the stricter 90-working-day rule.

Insight 2: change one, equal standing of the authorized representative alongside the manufacturer. Decision No. 43 of 2026 makes clear that all inspection procedures must involve the manufacturer of the medical device and its formally authorized representative, and that the authorized representative has the right to submit applications for periodic and unscheduled inspections, to coordinate with accredited inspection organizations and to sign the contracts for conducting inspections. GRZAN points out that this is a fundamental repositioning of the authorized representative within the Union compliance system: previously the manufacturer was the sole responsible party in the core stages of inspection and contracting while the representative only assisted with communication; after the amendment the representative can lead the process and share responsibility with the manufacturer.

Insight 3: changes two and three, time limits are quantified for the first time. The amendment states that the duration of periodic and unscheduled inspections must not exceed 90 working days, and that the application for a periodic inspection must be submitted at least 90 working days before the previous inspection report expires. GRZAN points out that Decision No. 106 already provided that the total period for organizing and conducting a production inspection, counted from the decision to start the inspection, must not exceed 90 working days; the 2026 amendment extends this cap to the two periodic inspection scenarios and gives, for the first time, a hard advance filing deadline, which significantly improves scheduling certainty for manufacturers.

Insight 4: change four, sterilization facility inspection results can be shared across manufacturers. After the amendment, where the medical devices of several manufacturers are sterilized using the same sterilization facility, the production conditions relating to that facility previously had to be inspected separately for each customer; the amendment removes the need for duplicate inspections, because the assessment results on the production conditions of that sterilization facility obtained during the inspection of one manufacturer can be recognized and used by other manufacturers. The precondition is that the manufacturer holds a valid production inspection report in which the relevant sterilization facility information is recorded. GRZAN points out that this is a substantive relief for consumable manufacturers using outsourced sterilization, but the facility information must be completely recorded in their own inspection report, otherwise the sharing mechanism cannot be invoked.

Insight 5: the supporting methodological document was updated in parallel. Recommendation No. 6 of the Board of the Eurasian Economic Commission, dated 2026-04-07, issued methodological recommendations on production inspections of medical devices. GRZAN points out that recommendation-type documents do not create obligations, but they are cited by inspection organizations in practice and should be treated as an input for inspection preparation, particularly for the design of quality management system documentation and site walkthroughs.

4. Practical recommendations

1. Determine inspection obligations by risk class: place Class 2a sterile, Class 2b and Class 3 on the mandatory inspection list, and treat Class 1 and Class 2a non-sterile as voluntary applications driven by commercial needs.
2. Rewrite the powers of attorney: add the three authorizations for submitting inspection applications, coordinating with inspection organizations and signing inspection contracts under the 2026 rules, together with an explicit joint liability clause.
3. Run an inspection countdown: work backwards from the 3-year validity of the inspection report, complete the periodic inspection application at least 90 working days before expiry, and reserve a 90-working-day implementation window.
4. Document outsourced sterilization: record the sterilization facility information in the manufacturer’s own inspection report, preserving the basis for later invocation of the result-sharing mechanism.
5. Cover all sites in one initial inspection: the initial inspection covers all declared manufacturing sites, so confirm the site list before filing to avoid supplementary inspections caused by omissions.

5. Verification checklist

1. □ Whether the device falls within the mandatory inspection scope, Class 2a sterile / Class 2b / Class 3, has been determined by risk class.
2. □ The effective date of Decision No. 43 of 2026, 2026-06-18, and its four changes have been confirmed.
3. □ The powers of attorney have been rewritten under the new rules with the three authorizations for inspection applications, coordination and contract signing.
4. □ A countdown ledger based on the 3-year validity of inspection reports has been established.
5. □ The 90-working-day advance filing for periodic inspections has been written into the annual quality plan.
6. □ It has been confirmed that the outsourced sterilization facility information is recorded in the manufacturer’s own inspection report.
7. □ All manufacturing sites have been declared, avoiding omissions in the initial inspection.

Regulatory information verified as of October 30, 2026.

GRZAN service note. GRZAN supports manufacturers in preparing for quality management system production inspections in the Eurasian Economic Union and Armenia, including risk-class obligation mapping, inspection countdown planning, authorized representative restructuring and sterilization result sharing. Regulatory monitoring is updated continuously and confirmed against the official sources cited above. For inquiries, contact info@grzanglobal.com.