Armenia Sterile Medical Device Evidence: Inspection, Labelling and Certificate Rules

1. Key takeaways

Sterile class 2a, class 2b and class 3 devices sit on the mandatory trigger line for manufacturing site inspections, while non-sterile class 1 and class 2a devices remain within the voluntary application zone. The GRZAN conclusion is that the sterile state is not just a labelling field: it directly changes three downstream obligations — the site inspection turns from voluntary to mandatory, the label must state the sterilisation method, and combining multiple models under one certificate requires the condition of identical sterility including the sterilisation method to be met. The question of whether a product is sterile is the single judgement with the largest cost impact in product line planning.

2. Legal basis

3. Expert insights

Insight one: sterility is one of the trigger conditions for a manufacturing site inspection. Under the system established by Decision No. 106, inspections are mandatory for sterile class 2a, class 2b and class 3 medical devices, regardless of whether in vitro diagnostics are involved, while for non-sterile class 1 and class 2a devices inspection applies only on a voluntary basis. The GRZAN observation is that this dividing line puts sterile class 2a and non-sterile class 2a products in different orders of compliance cost, and companies should therefore assess rigorously whether the sterile state is genuinely necessary at the product definition stage.

Insight two: Decision No. 27 writes the sterilisation method into the mandatory label content. Under the labelling requirements of Decision No. 27, where a device is supplied sterile the label must carry sterile-state information with the sterilisation method indicated; warnings and precautions must be displayed in a way that draws the attention of the user or third parties, and where more detail is given in the instructions for use, the label may keep such information to a minimum. The GRZAN observation is that the sterilisation method stated on the label — ethylene oxide, irradiation, moist heat — must match the sterilisation validation records; a mismatch between the label and the dossier is a high-frequency nonconformity.

Insight three: Article 19, subparagraph h, lists sterility including the sterilisation method among the identical characteristics required for combining certificates. The provision states that where several models are included under one registration certificate, the models must share identical characteristics in terms of scope of application, invasiveness, sterility (taking into account the sterilisation method), frequency of use (single use, repeated use on a single patient, repeated use on multiple patients), design and structural features, and duration of use. The GRZAN observation is that if a model family contains one version sterilised by ethylene oxide and another by irradiation, the two cannot be combined under a single registration certificate.

Insight four: Decision No. 43 of 2026 opens a sharing route for outsourced sterilisation. Before the amendment, where medical devices of several manufacturers were sterilised in the same sterilisation facility, the production conditions at that facility had to be inspected separately for each customer, creating excessive administrative and financial burdens. The amendment removed the duplication: the assessment of the production conditions of the sterilisation facility obtained during an inspection of one manufacturer may be recognised and used by other manufacturers. The precondition is that the manufacturer holds a valid manufacturing site inspection report in which the relevant sterilisation facility is identified. The GRZAN observation is that consumables manufacturers using outsourced sterilisation should ensure their own inspection report records the name, address and process details of the sterilisation facility in full.

Insight five: the validity period and extension rules of inspection reports. Article 33 of Decision No. 106 provides that the initial manufacturing site inspection report is valid for 3 years from the date of issue. Article 34 provides that inspection results extend across a product group (class 1 and class 2a, sterile and non-sterile) or subgroup (class 2b and class 3). When submitting a registration application for a device under a new name, if the production site has previously been inspected for devices of the same group or subgroup, the applicant must attach a copy of the manufacturing site inspection results issued no earlier than 3 years before the application date. The GRZAN observation is that the 3-year period is the key scheduling parameter for sterile product lines.

4. Practical recommendations

1. Assess the necessity of sterility before freezing the design: treat the sterile state as a cost decision in product definition, evaluating its impact on inspection, labelling and certificate splitting.
2. Keep the label and the dossier consistent: maintain a single source of truth for the sterilisation method field, synchronised across the label, the dossier and the sterilisation validation records.
3. Split certificates by sterilisation method: where a model family carries different sterilisation methods, file separate registration certificate applications.
4. Document outsourced sterilisation: record the sterilisation facility information explicitly in your own inspection report, preserving the basis for invoking the 2026 sharing mechanism.
5. Manage the 3-year cycle: run a countdown register against the 3-year validity of inspection reports and file the periodic inspection application 90 working days before expiry.

5. Verification checklist

1. □ It has been confirmed whether the product falls within the mandatory inspection scope (sterile class 2a, 2b or 3).
2. □ The label states the sterile state and sterilisation method, consistent with the dossier.
3. □ The sterilisation method within the model family is uniform; otherwise separate applications have been filed.
4. □ The outsourced sterilisation facility information is recorded in the company’s own inspection report.
5. □ A countdown register against the 3-year validity of the inspection report is in place.
6. □ The periodic inspection application, due 90 working days in advance, is written into the annual quality plan.
7. □ A copy of an inspection report issued no earlier than 3 years before the application date is attached for new-name device applications.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with sterile device compliance for the Armenian market, from inspection scoping and sterilisation labelling audits to certificate-splitting strategies and 3-year report cycle management. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.