Market Surveillance and Inspection of Medical Devices in Iran

1. Key takeaways

The Iranian competent authority carries out market surveillance and spot checks on devices placed on the market, and the inspection focuses on consistency of certificates and licences, labelling and instructions for use, traceability marks and quality system records. GRZAN’s assessment is that whether a spot check passes smoothly depends on the day-to-day document management of the local importing company, not on last-minute preparation. Companies should build an inspection-ready document package immediately after market entry, so that it can be presented at any time. Inspection readiness is a standing condition, not an event that can be improvised when the inspectors arrive at the warehouse door, and the difference between the two shows immediately in how calmly the inspection proceeds and how few questions escalate. The four focus areas also give the document package its structure: one section per focus area means the inspectors’ questions can be answered in the order they are asked.

2. Legal basis

1. Market surveillance and spot checks: the competent authority carries out supervisory spot checks and annual reviews of products placed on the market — see public industry sources; the official Iranian document number has not been published through public channels, and this is a practical estimate. Companies should therefore treat the existence and scope of inspection activity as established market practice, and build their readiness around the practice rather than around a citable provision, assuming that inspections can happen without advance notice.
2. Law on the Administration of Medical, Pharmaceutical, Food and Beverage Affairs, FAOLEX LEX-FAOC227692, dated 1955-06-20, Article 3 (import and sale require approval; unauthorised changes to labelling are prohibited) and Article 11 (penalties). This is the provision an inspection ultimately tests against: a product on the shelf must match its approval, and its label must match its approved version, with the penalties of Article 11 behind both requirements.
3. TTAC traceability mark requirements — this is a practical estimate. The requirement operates in practice through the traceability codes carried on the product, which inspectors can verify on the spot.

3. Expert insights

Insight one: consistency of certificates and licences is the first item checked. On the spot, the inspectors verify whether the physical product matches the registration information — model, manufacturer, IRC. Any inconsistency triggers further investigation, because from the inspector’s point of view a mismatch between the physical unit and the registered record raises the question of whether the unit in front of them is the product that was approved at all. Everything else in the inspection proceeds differently once that question is open, which is why this item comes first. The check is also fast and effectively binary: the unit either matches the record or it does not, and a mismatch found here usually turns the rest of the inspection into an investigation.

Insight two: labelling is the part of the inspection where problems are most easily found on the spot. Article 3 prohibits unauthorised changes to labelling, so the content and format of the Persian-language label must be fully consistent with the version approved at registration. A label that has drifted from the approved version, even in minor wording, exposes the shipment to questioning that a perfectly aligned label would never attract, and the drift is visible to anyone holding the product and the approval side by side. Because the comparison is made against the approved version, the approved version must be on site, and a missing reference document is itself a finding.

Insight three: the scannability of traceability marks will be physically tested. Inspectors may actually scan the traceability code on the product and verify that it is readable in the TTAC system. This action directly connects the identification work done before market entry with the inspection outcome after market entry: a code that was implemented carelessly will fail exactly when it is checked in the field, and there is no way to remediate it on the spot during an inspection. Quarterly self-scanning closes exactly this gap, by finding unreadable codes while they can still be traced back to a batch and reprinted.

4. Practical recommendations

1. Build an inspection-ready document package: registration certificate, IRC, approved label version, instructions for use, quality system certificate and import documents, stored in one central place so they can be produced immediately and so their completeness can be verified routinely rather than under pressure, with a contents list on the cover so one pass confirms nothing is missing.
2. Keep labels strictly identical to the approved version: any change goes through the formal channel first and only then reaches the market, never the other way round, because a corrected-after-the-fact label is still an unauthorised label in the inspector’s eyes, and superseded versions should be archived so the history of the label can be shown if asked.
3. Test the scannability of traceability codes periodically: sample and scan every quarter to verify readability, so that degradation is caught long before an inspector finds it and can be traced back to the batch or the printing process that caused it.
4. Designate a local contact person: spot checks are handled by the local entity, so a contact with decision-making authority must be designated in advance rather than improvised on the day, since hesitation at the warehouse door is itself a bad answer, and a deputy should be named too so the inspection is never answered by an empty chair.

5. Verification checklist

• □ The inspection-ready document package has been built and stored centrally
• □ The labels actually used on the market have been checked for consistency with the approved version
• □ The scannability of traceability codes has been verified by quarterly sampling
• □ A local contact person has been designated with clearly defined decision-making authority
• □ The response process for spot checks has been rehearsed and documented

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Iranian market. Our team manages adverse event reporting and recall coordination with IFDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com