Technical Review of High-Risk Devices such as Dialysis Equipment in Iran

1. Key takeaways

High-risk devices such as dialysis equipment enter a dedicated technical review in Iran, and the scope of that review extends beyond safety and effectiveness itself to include adaptation to the local environment. The judgment of GRZAN is that the Iranian reviewer’s attention to whether the device can actually operate in Iran is higher than most first-time applicants expect. The most frequent points of failure concentrate in three items: electrical grid adaptation, stability under high-temperature conditions, and the Persian-language operating interface. If these three items are not resolved, the safety and effectiveness documentation will still draw deficiency requests no matter how complete it is, because the reviewer cannot sign off on a device whose operational environment has not been demonstrated. The review is thus not a translation exercise of European documentation; it is an operational demonstration that the device functions under Iranian conditions.

• Class C and Class D products must submit stricter technical documentation together with clinical evaluation or clinical trial evidence.
• IEC 60601 (medical electrical equipment safety and EMC), ISO 10993 (biocompatibility) and IEC 62304 (medical device software lifecycle) are international standards generally accepted by the Iranian authority.
• Where a corresponding ISIRI mandatory standard exists, the ISIRI determination prevails over the international standard.
• Persian-language labelling and instructions for use are required, and localisation adaptation evidence is examined even though it does not appear on a published checklist.
• The Iranian grid operates at 220V, summer temperatures are high in parts of the country, and water quality differs from European conditions, so environment-specific stability evidence is expected.
• Persian operating interface, local emergency contact number and maintenance period descriptions are all checked as review items.
• Localisation adaptation should be submitted as a consolidated chapter so the reviewer finds one coherent answer instead of assembling one from scattered parameters.
• Deficiency requests on environment adaptation recur because applicants treat grid, temperature and water quality as installation details rather than as review evidence.

2. Legal basis

On the technical review of high-risk devices: Class C and Class D products are required to submit stricter technical documentation together with clinical evaluation or clinical trial evidence. This is documented in public industry material; the Iranian official document number has not been released through public channels, and this is a practical estimate.

On standards: the IEC 60601 series covering safety and electromagnetic compatibility of medical electrical equipment, the ISO 10993 series covering biocompatibility, and IEC 62304 covering the software lifecycle of medical device software are international standards generally accepted by the Iranian competent authority. Where a corresponding ISIRI mandatory standard exists, the ISIRI determination prevails — this is a practical estimate. In dossier planning this means each standard reference must be checked against the current ISIRI catalogue before it is cited.

On language: the requirement for Persian-language labelling and instructions for use is documented in public industry material and is likewise a practical estimate as to its formal source. Whatever its codified form, it is enforced in practice at the sample review stage, which is what matters for project planning.

3. Expert insights

Insight 1: localisation adaptation is a hidden test item — it is not written on the checklist but it is always asked. The Iranian grid runs at 220V, some regions experience high summer temperatures, and water quality conditions differ from those in Europe. Reviewers look for evidence of device stability under exactly these conditions. GRZAN recommends submitting the localisation adaptation as a standalone chapter of the dossier rather than scattering it across technical parameter sheets, so that the reviewer finds a consolidated answer instead of assembling one.

Insight 2: the clinical evidence requirement for high-risk devices is higher. Class C and Class D products need clinical evaluation reports based on scientific literature, and novel technologies may be asked to supplement local clinical data. Companies should anticipate, while preparing their clinical evidence, the scenario in which local data will be requested, so that the request does not arrive as an unmanageable surprise and clinical institutions can be contacted early. The cost of preparing this anticipation is low compared with the delay caused by a mid-review request for local data that no institution has been contacted about.

Insight 3: interface language and local service entry points are review items. The Persian operating interface, the local emergency contact telephone number and the maintenance period descriptions are all examined. This functions both as language compliance and as proof of local service capability, and a device that cannot demonstrate a serviceable presence in Iran will struggle on precisely this point. Service information is also among the first things a hospital procurement team asks about, so front-loading it serves both the review and the market.

4. Practical recommendations

• Submit a standalone localisation adaptation chapter: consolidate grid adaptation (220V), high-temperature stability and the water treatment plan into one coherent chapter.
• Complete the Persian interface before sample submission: Persianise the software interface and the instructions for use together, avoiding a second sample submission and the delay it implies.
• Reserve an interface for local clinical data: anticipate the scenarios in which supplementary local clinical data may be requested and contact clinical institutions early.
• Front-load local service information: write the emergency contact number, maintenance period and after-sales network into the instructions for use and the labels.

5. Verification checklist

• □ Grid adaptation (220V) and high-temperature environment stability have been verified
• □ The Persian operating interface and instructions for use have been completed and synchronised
• □ The clinical evaluation report has been submitted, and a plan for supplementary local clinical data has been anticipated
• □ Localisation adaptation has been submitted as a standalone chapter, not scattered across parameters
• □ The local emergency contact number and maintenance period have been written into labels and instructions for use

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 IFDA registration applications, prepares reference-country dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com