ISO 10993 Biological Evaluation Requirements for Medical Devices in Iran

1. Key takeaways

Biological evaluation in Iran is conducted under the ISO 10993 series, and the evaluation items are determined by the contact type and contact duration — not by a fixed checklist. The item set follows the device, not a template. The judgement of GRZAN is that the two most common company errors are, first, underestimating the contact duration, and second, misunderstanding the rules for carrying over existing data. The former leaves evaluation items missing and triggers deficiency requests; the latter leads to duplicate testing and wasted cost. Both errors share one root cause: treating the evaluation as a form to be filled in rather than a question to be reasoned about.

• Biological evaluation follows the ISO 10993 series, with the item set driven by contact type and contact duration. These two inputs determine the item set before any test is scheduled, so settling them first is the fastest route to a correct plan.
• There is no fixed checklist; the evaluation items are derived from the contact classification of the device.
• Error one: underestimating contact duration leaves items missing from the evaluation and triggers deficiency requests. The deficiency arrives late in the review, when it costs the most.
• Error two: misunderstanding the carry-over rules for existing data leads to tests being repeated that the existing data already covered. Duplicated testing is pure cost with no regulatory benefit.

2. Legal basis

The legal and normative references supporting this module are the following.

1. ISO 10993-1:2018 (Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process): generally accepted by the Iranian authorities; where a corresponding ISIRI standard exists, conformity is judged against the ISIRI standard — this is a practical estimate.
2. Contact classification rules: the evaluation items are determined by the three contact categories — surface contact, externally communicating and implant devices — combined with the contact duration (≤24 hours, >24 hours to 30 days, >30 days) — this is a practical estimate.
3. Law on the Administration of Medical, Pharmaceutical and Food-Beverage Affairs, FAOLEX LEX-FAOC227692, 1955-06-20, Article 3.

3. Expert insights

Insight 1: contact duration is the watershed for the number of evaluation items. Moving from ≤24 hours of contact to >30 days significantly increases the number of evaluation items that must be added — for example chronic toxicity, carcinogenicity and local effects after implantation. The classification is not a formality; it is the mechanism that scales the evaluation to the real exposure of the patient. This is also where a wording problem in the instructions for use becomes a testing problem: if the instructions describe the use scenario as long-term contact, the evaluation requirements rise accordingly, whether or not the company intended that reading. The contact duration stated in the documents and the contact duration assumed by the test plan must be the same duration, checked deliberately rather than accidentally. A device whose instructions describe long-term contact will be evaluated as long-term contact, whatever the test plan says.

Insight 2: the legitimate route to exemption is an equivalence argument. If the product is equivalent to an already marketed product in materials, manufacturing and contact conditions, existing data may be carried over through argumentation rather than repeat testing. The saving is real, but only when the argument is built properly. The key requirement is that the argument must cover all of the variables: material sourcing, processing, sterilization method and the remaining factors that could change the biological response. An equivalence argument that skips one of these variables is not a saving; it is a deficiency request waiting to be issued, plus a reputation for loose documentation that follows the rest of the dossier. The argument should be written down, not merely agreed in conversation.

Insight 3: biological evaluation is part of risk management, not a standalone report. ISO 10993-1:2018 positions the evaluation explicitly within a risk management process, and reviewers read it that way. The standard’s own framing is the reviewer’s expectation. The dossier should show the correspondence between the biological evaluation and the risk management documents — the hazards the evaluation addresses should appear as risks the risk file handles, and the conclusions of the evaluation should land in the risk conclusions. Submitting the biological evaluation in isolation from the risk management file, as if the two were parallel obligations with no connection, invites the reviewer to question whether either document was written with the other in view. A cross-referenced pair, by contrast, reads as one coherent argument. Cross-referencing costs an afternoon of editing and prevents a category of questions that otherwise recurs throughout the review.

4. Practical recommendations

• Determine the contact type and duration first, then the items: do not apply a fixed checklist; derive the items from the classification instead.
• Run the equivalence argument in full: compare materials, manufacturing, sterilization, packaging and contact conditions one by one. Every variable gets a written comparison.
• Cross-reference with the risk management documents: the conclusions of the biological evaluation must be carried into the risk documents and settled there, so the two documents read as one argument rather than two parallel ones.
• Prepare additional sourcing evidence for animal-derived materials: where animal-derived components are involved, prepare the sourcing and processing documentation in parallel, starting alongside the evaluation rather than after it.

5. Verification checklist

• □ The contact type and contact duration have been defined and the evaluation items determined
• □ Exempted items are supported by an equivalence argument covering all variables
• □ The conclusions of the biological evaluation have been cross-referenced with the risk management documents
• □ Sourcing and processing evidence for animal-derived components has been prepared
• □ The rules for carrying over existing data have been explained in writing in the dossier

Regulatory information verified as of October 29, 2026

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 prepares IFDA-compliant dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com