Medical Device Technical Review in Iran: The COME and MDB Committee Process

1. Key takeaways

Technical review of medical devices in Iran is carried out by the Medical Device Committee (in industry material also referred to as the Committee on Medical Equipment, COME, or the Medical Device Board, MDB). Its operating logic is a triage system: most routine products follow the general licensing pathway, and a full case-by-case technical review is triggered only when a product category falls on the committee’s exclusion list. GRZAN’s assessment is that companies able to demonstrate that they are not on the exclusion list see their review cycles shorten markedly; for this reason, the first page of a submission should be the “applicable pathway argument”, not the technical parameters. Reviewers read the opening page first, and the question they need answered before anything else is whether this case belongs in the general queue or in the committee’s own docket. A dossier that answers that question on page one lets the reviewer route the case immediately; a dossier that opens with specifications forces the reviewer to reconstruct the routing decision from scattered material, and every such reconstruction invites delay. The pathway argument is therefore not decoration but routing infrastructure, and it costs a single page to build. A practical way to test whether the argument is doing its job is to hand the first page to a colleague who knows nothing about the product: if they can say which queue the case belongs in and why, the page works; if they cannot, the page needs another revision before the dossier moves.

2. Legal basis

1. The Medical Device Committee review mechanism: the committee conducts technical review of safety, effectiveness and conformity with Iranian standards; review depth increases with risk class A/B/C/D — the mechanism is described in public industry material; no official document number has been published through open channels, so this is a practical estimate. Triage of this kind is standard where capacity is limited, and the practical consequence for applicants is that the burden of showing the correct route sits with the dossier itself.
2. The Directive on Issuance and Extension of Manufacturing Licences for Medical Equipment and Supplies: Class A and Class B manufacturing licence applications, tracking and certification are fully electronic end to end — cited from the public page of the Food and Drug Deputy of Iran University of Medical Sciences; no official document number has been identified, so this is a practical estimate.
3. The Seventh National Development Plan Law of the Islamic Republic of Iran, in force for Iranian calendar years 1403–1407, Chapter 14, Article 72, paragraph B (promoting regional mutual recognition and the issuance of registration certificates and market access licences).

3. Expert insights

Insight one: triage determines where review capacity is directed. Iran’s review capacity is finite, so a triage mechanism is the inevitable design. This means that if a company can argue its product’s routine character clearly, it can avoid the longest queue. GRZAN places the “applicable pathway argument” as the fixed opening chapter of every Iranian dossier. The argument does not need to be long; it needs to be decisive — naming the category, showing its position relative to the exclusion list, and pointing to comparable approvals in reference countries. Reviewers respond to files that respect their routing logic, and respect in this context is demonstrated structurally rather than rhetorically. The argument should also state, in one sentence, what the product is not, since exclusion lists are often framed by categories the product could be mistaken for.

Insight two: the review focus for high risk classes is predictable. For Classes C and D, review concentrates on three items: clinical evidence, risk-benefit analysis and quality system on-site assessment. Preparation for all three can be brought forward entirely, without waiting for the authority to issue deficiency requests. A Class C or D applicant who assembles these three workstreams before submission converts the most demanding part of the review into a confirmation exercise, and the deficiency cycle, which is where high-risk timelines usually bleed out, largely disappears. Bringing the three workstreams forward has a second benefit: the material produced for them raises the overall quality of the file, because clinical and risk-benefit writing done early is reviewed more calmly than writing done against a deficiency clock.

Insight three: Article 72, paragraph B is changing the committee’s output. The development plan law requires the Ministry of Health and Medical Education to promote regional acceptance of Iranian registration outcomes and to issue joint production quality certificates. The committee’s future review outputs will increasingly carry an “acceptable to other states” character. Organising material to a standard that a third party can re-verify is therefore a low-cost forward-looking investment when preparing a file today, because the same structure that serves an Iranian reviewer will serve a regional counterpart later with minimal rework. Companies exporting to several regional markets can treat this as an argument for a single master dossier architecture, maintained once and adapted per destination.

4. Practical recommendations

1. Open the dossier with the “applicable pathway argument”: use 1 page to argue why the general licensing pathway applies, attaching approvals from reference countries and the risk class basis.
2. Complete the 3-item preparation for Classes C/D: clinical evidence, risk-benefit analysis and quality system audit readiness, all finished before submission.
3. Organise material to the 4-item standard of third-party re-verifiability: dossier structure, indexing and the evidence chain are clear, leaving room for later regional mutual recognition.
4. Route Classes A/B through the electronic channel first: make full use of the fully electronic manufacturing licence and submission processes to reduce paper round trips and the delays they carry.

5. Verification checklist

• □ The dossier’s first chapter contains the “applicable pathway argument” with reference-country approval evidence attached
• □ The risk class and corresponding review depth have been confirmed, and the review focus list has been drawn up
• □ The three Class C/D materials (clinical, risk-benefit, quality system) were complete before submission
• □ For Classes A/B it has been confirmed that the fully electronic channel is available
• □ The dossier structure meets third-party re-verifiability requirements (index, version, dates all present)

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 manages IFDA (Iran FDA) registration procedures, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com