Medicines and Medical Devices Regulatory Agency (MMRA) · structured requirements

🇲🇳 Mongolia IVD regulatory data

Explore the IVD requirements currently available for Mongolia, organized by topic and linked to official sources.

31 facts22 dimensions10 official sourceslatest verification 2026-09-17

Changes after registration

Common questions about changing a registered IVD in Mongolia. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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IVD registration and certificate are valid for five years; renewal must be requested two months before expiry

validity.ivd-registration-five-years-renewal-two-months-before

Fact-level verified

Laboratory diagnostic devices are registered, extended and certified for a period of five years. The registrant must submit a request to extend the period two months before the registration's validity expires, together with the complete registration documents and a statement of the quantity of stock remaining on the market. A device differing from the registered or listed model is treated as invalid. Renewal documents include the post-market surveillance report.

Conditions

State registration of high- and medium-risk IVDs for five years is also provided in Law Art. 33.4.
Market surveillance and a user study are carried out before renewal (§2.11).
The renewal dossier is at §2.12.2.1–§2.12.2.4.

Source language: Mongolian. Verbatim §1.3: "Лабораторийн оношилгооны хэрэгслийг 5 жилийн хугацаагаар бүртгэж, сунган, гэрчилгээ олгоно." Translation: "Laboratory diagnostic devices shall be registered, extended and certified for a period of 5 years." Verbatim §2.9: "Бүртгүүлэгч бүртгэлийн хүчинтэй хугацаа дуусахаас 2 сарын өмнө хугацаа сунгуулах хүсэлтийг ирүүлж, бүртгэлийн баримт бичгийг бүрэн хүлээлгэн өгөх бөгөөд зах зээлд байгаа үлдэгдэл нөөцийн хэмжээг тусгасан байна." Translation: "The registrant shall submit a request to extend the period 2 months before the expiry of the registration's validity and shall hand over the registration documents in full, and shall state the quantity of remaining stock on the market."

Authority & regime

Which authority and binding regime govern this product, task, and date?

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The Agency's published structure includes a dedicated Medical Equipment Division

authority.agency-structure-includes-medical-equipment-division

Fact-level verified

The Agency's own site describes it as a Government implementing agency and publishes its management structure, which includes a Medical Equipment Division (Эмнэлгийн тоног төхөөрөмжийн газар) alongside the Administration and Management Division, the Licensing and Permits Regulatory Division, the Pharmacovigilance Surveillance and Research Division, the Medicines Supply Division, the Quality Control Division, the Medicines Registration Department, the Medicines Manufacturing Department and the Medicines Testing Laboratory. The Agency's published contact details are an Ulaanbaatar address in Chingeltei district, telephone +(976) 51-260182, and the abbreviation ЭЭХХЗГ.

Conditions

Confirms that medical devices are handled within the Agency rather than by a separate body.
The site header and body spell the name with and without a comma after 'Эм'; the legal instruments use the comma form 'Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар'.

Source language: Mongolian. Verbatim: "Засгийн газрын хэрэгжүүлэгч агентлаг Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар нь:" Translation: "The Government implementing agency, the Medicines and Medical Devices Control and Regulatory Agency:" The structure list is published verbatim as: "Удирдлагын баг / Захиргаа, удирдлагын газар / Лиценз зөвшөөрлийн зохицуулалтын газар / Эмийн аюулгүй байдлын тандалт, судалгааны газар / Эм хангамжийн газар / Чанарын хяналтын газар / Эмнэлгийн тоног төхөөрөмжийн газар / Эмийн бүртгэлийн хэлтэс / Эм үйлдвэрлэлийн хэлтэс / Эм шинжлэх лаборатори" Translation: "Management team / Administration and Management Division / Licensing and Permits Regulatory Division / Pharmacovigilance Surveillance and Research Division / Medicines Supply Division / Quality Control Division / Medical Equipment Division / Medicines Registration Department / Medicines Manufacturing Department / Medicines Testing Laboratory". Contact block verbatim: "Монгол улс, 15160 Улаанбаатар хот, Чингэлтэй дүүрэг, 3-р хороо, Энхтайваны өргөн чөлөө, Энхтайван найрамдлын ордон", "+(976) 51-260182", "info@mmra.gov.mn", abbreviation "Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар-ЭЭХХЗГ".

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Amendments require a five-item dossier for IVDs; listed equipment and consumables are updated in the electronic database

change.amendment-documents-and-listing-update

Fact-level verified

An amendment to an IVD registration requires a request, a comparison of the label and packaging, a risk assessment with stability data, a comparison of ISO certificates, the manufacturer's explanation, and national reference laboratory results, non-clinical study data or a clinical evaluation. For listed medical equipment and consumables, a request to change the listed information is uploaded to the electronic database within 10 working days of receipt in accordance with the working office's decision, and listing amendments are supported by the documents at §3.11.

Conditions

A device differing from the registered or listed model is treated as invalid (§1.4).
IVD amendment dossier: §2.12.3.1–§2.12.3.5; listing amendment dossier: §3.11.1–§3.11.5.

Source language: Mongolian. Verbatim §3.6: "Жагсаалтад орсон эмнэлгийн тоног төхөөрөмж, эмнэлгийн хэрэглэгдэхүүний мэдээлэлд өөрчлөлт оруулах хүсэлт хүлээн авснаас хойш ажлын 10 хоногийн дотор ажлын албаны шийдвэрийн дагуу цахим мэдээллийн санд байршуулсан мэдээллийг шинэчилнэ." Translation: "Within 10 working days after receiving a request to make a change to the information of medical equipment and medical consumables entered on the list, the information posted in the electronic information database shall be updated in accordance with the working office's decision."

Classification rules

What local class follows from which rules and decisive product facts?

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The foreign risk class may permissively be taken into account when classifying a device

classification.foreign-risk-class-may-be-taken-into-account

Fact-level verified

Order A/136 §3.6 provides that in classifying a given medical device by risk grade, the risk grade to which it belongs in the country of manufacture may be taken into account. The verb is permissive (болно, "may"), not mandatory, and it does not name any foreign regulator, class scheme or approval.

Conditions

Permissive, not a requirement: the Agency may take the foreign class into account but is not bound to.
No foreign authority, jurisdiction or classification system is named anywhere in Order A/136.
This is a classification input only; it is not an approval-recognition route and creates no market-access right.

Source language: Mongolian. Read from rasterised page images (scanned PDF, no text layer). Verbatim §3.6: "Тухайн эмнэлгийн хэрэгслийг эрсдэлийн зэргээр ангилахад үйлдвэрлэсэн улсад ямар эрсдэлийн зэрэгт хамаарч байгааг харгалзан үзэж болно." Translation: "In classifying a given medical device by risk grade, the risk grade to which it belongs in the country of manufacture may be taken into account." This is the only place in any Mongolian device instrument retrieved for this round where a foreign risk class is mentioned.

Devices classified into three risk grades (I, IIa/IIb, III); IVDs into four classes (A, B, C, D)

classification.three-device-risk-grades-four-ivd-classes

Fact-level verified

Under the Agency head's Order A/136, medical consumables and medical equipment are classified by risk grade as low (I), medium (IIa, IIb) or high (III), and laboratory diagnostic devices (IVDs) are classified by risk grade as low (A), medium (B, C) or high (D). Classification of devices considers five factors (invasiveness, duration of use, body site, purpose of use, active/ non-active) and IVDs three factors; where more than one class could apply the highest class prevails. The classification list is built on the international GMDN nomenclature and is submitted to the Agency.

Conditions

The four IVD classes are written as three risk grades (low A; medium B, C; high D).
The classification list and the procedure for classifying devices by risk grade are approved by the head of the Agency (Law Art. 33.3).

Source language: Mongolian. The source PDF (mmra.gov.mn .../А136.pdf, stamped "Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газрын даргын 2026 оны 08 дугаар сарын 04-ны өдрийн А/136 дугаар тушаалын хавсралт", heading "ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ ЭРСДЭЛИЙН ЗЭРГЭЭР АНГИЛАХ ЖУРАМ") is a scanned PDF with no text layer, so the passage was read from rasterised page images. Verbatim §2.2: "Эмнэлгийн хэрэглэгдэхүүн, эмнэлгийн тоног төхөөрөмжийг эрсдэлийн зэргээр бага (I), дунд (IIa, IIb), өндөр (III) эрсдэлтэй гэж ангилна." Translation: "Medical consumables and medical equipment shall be classified by risk grade as low (I), medium (IIa, IIb) and high (III) risk." Verbatim §2.4: "Лабораторийн оношилгооны хэрэгслийг эрсдэлийн зэргээр бага (A), дунд (B, C), өндөр (D) эрсдэлтэй гэж ангилна." Translation: "Laboratory diagnostic devices shall be classified by risk grade as low (A), medium (B, C) and high (D) risk."

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evaluation and study results are a mandatory IVD registration dossier item

clinical.clinical-evaluation-results-required

Fact-level verified

Clinical evaluation and study results are a mandatory item of the IVD registration dossier. For amendments, clinical evaluation may be required as supporting evidence. No separate clinical-investigation authorisation procedure for medical devices was located in the instruments retrieved for this round.

Conditions

The requirement is a dossier item (Annex 2 §2.12.1.7) and an amendment supporting document (§2.12.3.5), not a standalone authorisation instrument.
No device clinical-investigation approval procedure was located; whether one exists outside the retrieved instruments is recorded as an open point.

Source language: Mongolian. Verbatim §2.12.1.7: "Эмнэлзүйн үнэлгээ, судалгааны дүн;" Translation: "Clinical evaluation and study results;" The bounded claim is limited to what the dossier list requires; this file does not assert that Mongolia has a clinical-investigation approval regime for devices, because none was located.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Law covers human medicines, medical devices and health supplements; veterinary products excluded

scope.law-covers-human-medicines-devices-and-supplements

Fact-level verified

The Law applies to relations concerning human medicines, medical devices and health supplementary products, and expressly does not apply to relations concerning veterinary medicines and devices, disinfection and sterilisation preparations, and feed supplements. "Medical device" is defined by intended purpose (prevention, diagnosis, treatment, monitoring of disease; supporting, replacing, restoring or rehabilitating bodily function; sterilising or disinfecting medical devices), with three enumerated sub-categories: laboratory diagnostic devices (IVDs) using samples taken from the human or animal body, medical equipment requiring the professional activity of a medical equipment engineer or technician, and medical consumables that are single-use or reusable.

Conditions

The IVD sub-category definition covers devices used with samples taken from the human or animal body, for diagnosing disease, therapeutic monitoring, confirmation, or detecting infection in biological products.
Veterinary devices, disinfectants/sterilants and feed supplements fall outside the Law.

Source language: Mongolian. Verbatim Art. 3.1: "Энэ хууль нь хүний эм, эмнэлгийн хэрэгсэл, эрүүл мэндийн нэмэлт бүтээгдэхүүнтэй холбогдсон харилцаанд үйлчлэх бөгөөд мал, амьтны эм, эмнэлгийн хэрэгсэл, ариутгал, халдваргүйтгэлийн бэлдмэл, тэжээлийн нэмэлттэй холбогдсон харилцаанд үйлчлэхгүй." Translation: "This Law shall apply to relations connected with human medicines, medical devices and health supplementary products, and shall not apply to relations connected with veterinary medicines and medical devices, disinfection and sterilisation preparations, and feed supplements." Verbatim Art. 4.1.10.а: "\"лабораторийн оношилгооны хэрэгсэл\" гэж хүн, амьтны биеэс авсан сорьцыг ашиглан өвчин эмгэгийг оношлох, эмчилгээний хяналт хийх, баталгаажуулах, биобэлдмэлд халдвар илрүүлэх зориулалттай дангаар болон бусад хэрэгсэлтэй хослуулан ашиглах эмнэлгийн хэрэгслийг;" Translation: "'laboratory diagnostic device' means a medical device intended, alone or in combination with other devices, to diagnose diseases, conduct therapeutic monitoring, confirm, or detect infection in biological products, using samples taken from the human or animal body;"

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Ten-item IVD registration dossier including ISO 13485, performance and stability data, clinical evaluation results and Mongolian-labelled IFU

dossier.ivd-registration-documents

Fact-level verified

The IVD registration dossier comprises an applicant's request; an introduction to the factory; a copy of the ISO 13485 certificate; evidence that the product falls within the 'laboratory diagnostic device' classification in its country of origin; quality, description, performance and stability data; laboratory test results and prototype test results; clinical evaluation and study results; the instructions for use for medical specialists together with a Mongolian copy; packaging artwork and samples; and accredited laboratory results where required.

Conditions

Clinical evaluation and study results are a mandatory dossier item (§2.12.1.7).
The IFU for medical specialists must be accompanied by a Mongolian copy (§2.12.1.8).
§2.12.1.4 does not apply to nationally manufactured IVDs.

Source language: Mongolian. Verbatim §2.12.1.7: "Эмнэлзүйн үнэлгээ, судалгааны дүн;" Translation: "Clinical evaluation and study results;" Verbatim §2.12.1.8: "Эмнэлгийн мэргэжилтнүүдэд зориулсан хэрэглэх заавар, Монгол хувийн хамт;" Translation: "Instructions for use intended for medical specialists, together with a Mongolian copy;" Verbatim §2.12.1.3: "ISO 13485 гэрчилгээний хуулбар;" Translation: "Copy of the ISO 13485 certificate;"

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Registration and listing are filed by the manufacturer, a supplying organisation or the manufacturer's official representative

operators.manufacturer-supplying-organisation-official-representative

Fact-level verified

An application for registration, renewal, amendment or de-listing is lodged with the Agency by the manufacturer, the supplying organisation (ханган нийлүүлэх байгууллага) or the manufacturer's official representative. Where a supplying organisation is to exercise the functions provided in Art. 40.8 of the Law in Mongolia, the listing dossier must include an original letter of the manufacturer designating that supplying organisation.

Conditions

An original manufacturer's letter designating the Mongolian supplying organisation is a mandatory dossier item for equipment listing (§3.9.12) and consumables listing (§3.10.12).
The applicant is responsible for the accuracy of the submitted information and pays the applicable fees (§3.4).

Source language: Mongolian. Verbatim §3.9.12: "Эмнэлгийн тоног төхөөрөмжийн ямар ханган нийлүүлэх байгууллага Монгол Улсад Эм, эмнэлгийн хэрэгслийн тухай хуулийн 40 дүгээр зүйлийн 40.8-д заасан чиг үүргийг хэрэгжүүлэхийг тодорхойлсон үйлдвэрлэгчийн албан бичиг эх хувь." Translation: "The original copy of the manufacturer's official letter designating which medical equipment supplying organisation is to exercise in Mongolia the functions provided in Article 40.8 of Article 40 of the Law on Medicines and Medical Devices." Verbatim §2.12: "... үйлдвэрлэгч, ханган нийлүүлэх байгууллага эсхүл үйлдвэрлэгчийн албан ёсны төлөөлөгч ... Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газарт ..." (the lodging parties are the manufacturer, the supplying organisation or the manufacturer's official representative, filing with the Agency).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Import-supply permit condition: premises and staffing meeting the storage-and-distribution standard

establishment.import-permit-premises-storage-distribution-standard

Fact-level verified

An application for the import-supply special permit must be supported by an expert conclusion and evidence on whether the applicant's buildings and premises, their organisation and its human resources meet the conditions and requirements of the good storage and distribution practice standard (эм хадгалалт, түгээлтийн зохистой дадлын стандарт). The parallel condition for the manufacture-export permit is the good manufacturing practice standard, plus documentation that production equipment meets its basic performance and safety requirements.

Conditions

An import-supply permit holder may hold additional warehouses; each additional warehouse is endorsed on the permit certificate on a commission decision (Art. 9.2).

Source language is Mongolian; verbatim passage and English translation below.

Import-supply special permit is required to import and supply medical devices

establishment.import-supply-special-permit-required

Fact-level verified

A legal entity may import and supply medical equipment, laboratory diagnostic devices and medical consumables only under an 'import-supply special permit' (импортлох-ханган нийлүүлэх тусгай зөвшөөрөл) granted on the decision of the special-permit commission and valid for the period set by Article 2.2(1) of the Law on Permits and Notifications. Manufacture-export is a separate permit (6.1.1) and retail sale a third (6.1.3). The import-supply and manufacture-export permits are granted, extended, suspended, restored and annulled by the state administrative body responsible for medicines and medical devices; the sale permit by the aimag or capital health department. A permit may not be sold, gifted, pledged or otherwise transferred.

Conditions

The permit is issued to a legal entity regardless of the form of ownership, alone or in combination with other permit directions (Art. 6.1).
The three device-relevant directions are manufacture-export (Art. 6.1.1), import-supply (Art. 6.1.2) and sale (Art. 6.1.3); the sale permit is issued by the local health department, not the national agency (Art. 6.4).

Source language is Mongolian; the passage is quoted verbatim below with an English translation. The article text was read in the consolidated 5 June 2024 version on legalinfo.mn (the page carries the text twice, once in capitals and once in normal case; both render the same wording).

Import-supply permit holder must supply wholesale to health organisations and pharmacies and may not handle unregistered devices

establishment.wholesale-supply-scope-and-unregistered-device-ban

Fact-level verified

A holder of the import-supply special permit must supply medical devices at wholesale price to health organisations and pharmacies, and is prohibited from importing, supplying or distributing devices that are not registered or not entered in the state register, and from breaching the storage, distribution and transport regime specified by the manufacturer.

Source language is Mongolian; verbatim passage and English translation below. The wholesale-channel restriction is written as a duty on the permit holder in Article 9.1.3; the separate prohibition in Article 9.4.3 names only medicines, so no device-specific 'may not sell to anyone else' claim is made here.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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IVD and equipment instructions for use must be in Mongolian; the equipment user manual and device labels may be Mongolian or English

label.ivd-ifu-mongolian-device-label-mongolian-or-english

Fact-level verified

The instructions for use of laboratory diagnostic devices must be in Mongolian and contain the prescribed information. The instructions for use of medical equipment must also be in Mongolian. The medical equipment user manual must be in Mongolian or English. Medical device labels and markings must be written in either Mongolian or English.

Conditions

IVD IFU content requirements: Arts. 38.3.1–38.3.6.
Equipment IFU content requirements: Arts. 38.5.1–38.5.6.
Equipment user manual content requirements: Arts. 38.6.1–38.6.12.
Annex 2 separately requires the IVD IFU to be filed with a Mongolian copy (§2.12.1.8) and the listing IFU to be filed with a Mongolian translation (§§3.9.9, 3.10.9).

Source language: Mongolian. Verbatim Art. 38.3 chapeau: "Лабораторийн оношилгооны хэрэгслийн хэрэглэх заавар монгол хэлээр байх бөгөөд дараах мэдээллийг агуулна:" Translation: "The instructions for use of laboratory diagnostic devices shall be in Mongolian and shall contain the following information:" Verbatim Art. 38.5 chapeau: "Эмнэлгийн тоног төхөөрөмжийн хэрэглэх заавар монгол хэлээр байх бөгөөд дараах мэдээллийг агуулна:" Translation: "The instructions for use of medical equipment shall be in Mongolian and shall contain the following information:" Verbatim Art. 38.6: "Эмнэлгийн тоног төхөөрөмжийн хэрэглэгчийн гарын авлага монгол, эсхүл англи хэлээр байх бөгөөд дараах мэдээллийг агуулна:" Translation: "The medical equipment user manual shall be in Mongolian or English and shall contain the following information:" Verbatim Art. 38.10: "Эмнэлгийн хэрэгслийн шошго, тэмдэглэгээ монгол, англи хэлний аль нэг хэлээр бичигдсэн байна." Translation: "Medical device labels and markings shall be written in one of the Mongolian or English languages."

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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Registration procedure adopted by Minister of Health Order No. A/206; Annex 2 governs medical devices

legal-basis.registration-procedure-order-a206

Fact-level verified

Minister of Health Order No. A/206 approves the registration procedures: Annex One for medicines and pharmaceutical substances, Annex Two for medical devices, Annex Three for health supplementary products, Annex Four the application form template, and Annex Five the registration certificate template. The Annex Two procedure (Эмнэлгийн хэрэгслийг бүртгэх журам) is the operative rule for IVD registration and for listing of medical equipment and consumables. The order repeals the annexes of Order A/295 of 2019 and Order A/176 of 2023.

Conditions

Dating discrepancy: the legalinfo.mn typed records for both the order and its Annex Two give 26 May 2025; the signed Ministry of Health PDF carries a handwritten date that reads 2025 оны 06 сарын 16 (16 June 2025). This file uses the typed-record date as effectiveFrom and records the discrepancy rather than asserting a single date.
Order A/206 was issued on the basis of Law on Government Art. 24.2 and Law on Medicines and Medical Devices Art. 15.4.
Order A/295 of 2019 (annexes 1, 3, 4) and Order A/176 of 2023 were repealed by paragraph 4.

Effective from 2025-05-26

Source language: Mongolian. Verbatim para. 1: "1.\"Эм, эмийн үйлчлэгч бодисыг бүртгэх журам\"-ыг нэгдүгээр, \"Эмнэлгийн хэрэгслийг бүртгэх журам\"-ыг хоёрдугаар, \"Эрүүл мэндийн нэмэлт бүтээгдэхүүнийг бүртгэх журам\"-ыг гуравдугаар, \"Бүртгэлийн өргөдлийн маягтын загвар\"-ыг дөрөвдүгээр, \"Бүртгэлийн гэрчилгээний загвар\"-ыг тавдугаар хавсралтаар тус тус баталсугай." Translation: "1. Let the 'Procedure for registering medicines and pharmaceutical substances' be approved as the first annex, the 'Procedure for registering medical devices' as the second, the 'Procedure for registering health supplementary products' as the third, the 'Registration application form template' as the fourth, and the 'Registration certificate template' as the fifth annex respectively." The legalinfo typed date is "2025 оны 5 дугаар сарын 26-ны өдөр", Дугаар А/206. The handwritten date on the signed PDF page 1 reads "2025 оны 06 сарын 16 өдөр", signed САЙД Т.МӨНХСАЙХАН.

Law on Medicines and Medical Devices (revised edition, 5 June 2024); registration procedure delegated to the Minister of Health

legal-basis.revised-law-2024-and-ministerial-delegation

Fact-level verified

The governing instrument is the Law on Medicines and Medical Devices (Эм, эмнэлгийн хэрэгслийн тухай хууль) in its revised edition adopted 5 June 2024 and subsequently amended on 3 July 2026. Article 15.4 delegates the procedure for registering medicines, medical devices, pharmaceutical substances and health supplements to the Government member in charge of health.

Conditions

The 2024 revised edition is the version in force; the text carries inline amendment markers from the law of 3 July 2026.
The Ministerial procedure adopted under Art. 15.4 is Order A/206 (see the separate legal-basis fact).

Effective from 2024-06-05

Source language: Mongolian. Adoption block: "МОНГОЛ УЛСЫН ХУУЛЬ / 2024 оны 06 сарын 05 өдөр / Төрийн ордон, Улаанбаатар хот / ЭМ, ЭМНЭЛГИЙН ХЭРЭГСЛИЙН ТУХАЙ / /Шинэчилсэн найруулга/" — translation: "Law of Mongolia, 5 June 2024, State Palace, Ulaanbaatar, On Medicines and Medical Devices, /Revised edition/". Verbatim Art. 15.4: "Эм, эмнэлгийн хэрэгсэл, эмийн үйлчлэгч бодис, эрүүл мэндийн нэмэлт бүтээгдэхүүнийг бүртгэх журмыг эрүүл мэндийн асуудал эрхэлсэн Засгийн газрын гишүүн батална." Translation: "The procedure for registering medicines, medical devices, pharmaceutical substances and health supplementary products shall be approved by the Government member in charge of health affairs." Amendment markers throughout read: "Энэ хэсэгт 2026 оны 07 дугаар сарын 03-ны өдрийн хуулиар өөрчлөлт оруулсан." ("This part was amended by the law of 3 July 2026.")

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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The supplying organisation must conduct surveillance on the devices it supplies, bear testing costs and recall non-conforming devices

pms.supplying-organisation-surveillance-and-recall-duty

Fact-level verified

The manufacturer and the supplying organisation must conduct surveillance studies (тандалт судалгаа) on the medical devices they supply and, where necessary, must bear the costs of testing medical consumables, of inspection, verification and calibration of medical equipment, and of analysis of laboratory diagnostic devices; where the requirements are not met they are obliged to recall the product. Market surveillance and a user study are also carried out before renewal of an IVD registration, and the renewal dossier includes a post-market surveillance report.

Conditions

The duty is placed on the factory and the supplying organisation jointly (үйлдвэр, ханган нийлүүлэх байгууллага).
A post-market surveillance report is a renewal dossier item (Annex 2 §2.12.2).
Market surveillance and a user study precede renewal (Annex 2 §2.11).

Source language: Mongolian. Verbatim Art. 35.2: "Үйлдвэр, ханган нийлүүлэх байгууллага өөрийн нийлүүлсэн эмнэлгийн хэрэгсэлд тандалт судалгаа хийж, шаардлагатай тохиолдолд эмнэлгийн хэрэглэгдэхүүнийг шинжлэх, эмнэлгийн тоног төхөөрөмжид шалгалт баталгаажуулалт, шалгалт тохируулга хийх, лабораторийн оношилгооны хэрэгслийн шинжилгээ хийх зардлыг хариуцаж, шаардлага хангаагүй тохиолдолд эргүүлэн татах үүрэгтэй." Translation: "The factory and the supplying organisation shall conduct surveillance studies on the medical devices they supply and, where necessary, shall bear the costs of testing medical consumables, of carrying out inspection and verification and calibration of medical equipment, and of carrying out analysis of laboratory diagnostic devices, and shall be obliged to recall them where the requirements are not met."

Official forms & portals

Which current form, portal, account, and submission package must be used?

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IVD registration applications are filed through the E-business electronic system

forms.e-business-electronic-filing-portal

Fact-level verified

Once the registration documents are complete, the applicant for laboratory diagnostic device (IVD) registration files them with the Medicines and Medical Devices Control and Regulatory Agency through the 'E-business' electronic system (Е-business цахим систем) and is issued a number; the registration fee must then be settled within 5 working days.

Conditions

This filing channel is stated in the IVD chapter of the procedure. The parallel route for medical equipment and medical consumables is entry into the medical device list, filed as paper documents (applicant's official letter plus the manufacturer-signed original application) under §§ 3.9–3.10.
The procedure numbers the filing as a stage of the registration sequence in § 2.1; no numbered paper form template is named in the instrument.

Source language is Mongolian; verbatim passage and English translation below. Review-time stages in § 2.3 are deliberately not reproduced here — review clocks belong to the typed dataset.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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State inspectors inspect device quality and safety and may inspect without a warrant on serious-risk findings

inspection.state-inspector-inspection-and-unannounced-entry

Fact-level verified

The state administrative body responsible for medicines and medical devices has medicines-and-medical-devices state inspectors whose duty is to carry out professional inspection (мэргэжлийн хяналт шалгалт) of the quality and safety of devices and of compliance with the legislation; the head of that body is the chief state inspector. The inspectors exercise the rights and duties of Article 10 of the Law on State Inspection and enjoy the guarantees of Article 11 of that law, and in addition may carry out an inspection without a warrant on the decision of a competent official where a situation has arisen that directly or indirectly causes, or is capable of causing, serious danger or harm to human life, health or the environment. They enforce the device legislation and standards and may inspect device imports and exports jointly with the customs authority.

Conditions

Relations connected with state-inspector inspection that this law does not regulate are governed by the Law on State Inspection (Art. 56.4).

Source language is Mongolian; the passages are quoted verbatim below with English translations. Inspection of overseas manufacturing sites is not provided for in these articles.

Manufacturer's ISO 13485 certificate is the QMS evidence required for device listing

qms.iso-13485-certificate-required-for-listing

Fact-level verified

The QMS evidence required to enter medical equipment into the medical device list is a copy of the manufacturer's medical device quality management system certificate (ISO 13485) certified by a competent authority and countersigned by the manufacturer; an application to renew an IVD registration must also include a copy of the manufacturer's ISO 13485 certificate.

Conditions

The certificate must be certified by a competent authority (Эрх бүхий байгууллагаас баталгаажуулсан), not merely issued by the certification body to the manufacturer.
The listing package also requires the product's marketing authorisation or free sale certificate (§ 3.9.5) and, for devices placed through a Mongolian supplier, the manufacturer's original letter designating that supplier (§ 3.9.12).

Source language is Mongolian; verbatim passage and English translation below. The claim is bounded to what the dossier requires: the procedure does not state whether a Mongolian on-site audit of the manufacturer is ever performed instead.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall deadlines of 24 hours, 72 hours or 14 days by severity; the supplying organisation bears the cost

recall.recall-deadlines-by-risk-and-cost

Fact-level verified

Where laboratory analysis shows that medicines, vaccines, biological products or medical devices fail the requirements, are unregistered, or may be counterfeit and may cause a serious risk to human life, they must be recalled within 24 hours; where they may pose a short-term health risk, within 72 hours; and where the probability of health risk or adverse effect is low, within 14 days. Recalls are carried out from health organisations, supply organisations and consumers under Art. 20.6, and the supplying organisation bears the cost of testing and of recall where requirements are not met.

Conditions

The deadline tiers are 24 hours (serious risk to life), 72 hours (short-term health risk) and 14 days (low probability of risk).
The recall duty runs from health organisations, supply organisations and consumers.
Costs are borne by the factory and the supplying organisation.

Source language: Mongolian. Verbatim Art. 20.9: "Лабораторийн шинжилгээний дүнгээр шаардлага хангаагүй, улсын бүртгэлд бүртгэлгүй, хуурамч байж болзошгүй эм, вакцин, биобэлдмэл, эмнэлгийн хэрэгсэл нь хүний амь насанд ноцтой эрсдэл учруулж болзошгүй бол 24 цагийн дотор, эрүүл мэндэд богино хугацааны эрсдэл үзүүлж болзошгүй бол 72 цагийн дотор, эрүүл мэндэд эрсдэл, сөрөг нөлөө үзүүлэх магадлал бага бол 14 хоногт багтаан эрүүл мэндийн байгууллага, хангамжийн байгууллага, хэрэглэгчээс энэ хуулийн 20.6-д заасны дагуу эргүүлэн татна." Translation: "Where laboratory analysis results show that medicines, vaccines, biological products or medical devices that fail the requirements, are not entered in the state register, or may be counterfeit, may cause a serious risk to human life, they shall be recalled within 24 hours; where they may pose a short-term risk to health, within 72 hours; where the probability of causing a risk or adverse effect to health is low, within 14 days, from health organisations, supply organisations and consumers in accordance with Article 20.6 of this Law."

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Medical device list is per-manufacturer, per-model or per-product number; nine categories are exempt from registration

pathways.device-list-route-and-exemptions

Fact-level verified

High- and medium-risk medical equipment and medical consumables are entered on the list by country of manufacture, manufacturer, model or product number individually. Nine categories of device do not require registration: low-risk devices other than IIa/IIb/III equipment, consumables and IVDs; spare parts; IVDs supplied under an external quality assessment contract; rare-disease IVDs; devices for research; registration samples; devices for exhibition; devices for use in a disaster or a serious public-health situation; and devices received by international post or carried by a passenger for a citizen's personal use. The last four categories of exempt device may not be sold.

Conditions

Devices in the exempt categories under Arts. 33.9.5, 33.9.6, 33.9.7 and 33.9.9 may not be sold (Art. 33.10).
The list entry is per country of manufacture, manufacturer, model or product number (Art. 33.8).

Source language: Mongolian. Verbatim Art. 33.8: "Өндөр, дунд эрсдэлтэй эмнэлгийн тоног төхөөрөмж, эмнэлгийн хэрэглэгдэхүүнийг үйлдвэрлэсэн улс, үйлдвэрлэгч, загвар, эсхүл бүтээгдэхүүний дугаар тус бүрээр нь жагсаалтад оруулна." Translation: "High- and medium-risk medical equipment and medical consumables shall be entered on the list by country of manufacture, manufacturer, model or product number individually." Verbatim Art. 33.10: "Энэ хуулийн 33.9.5, 33.9.6, 33.9.7, 33.9.9-д заасан эмнэлгийн хэрэгслийг худалдан борлуулахыг хориглоно." Translation: "The sale of medical devices provided in Articles 33.9.5, 33.9.6, 33.9.7 and 33.9.9 of this Law is prohibited."

Two authorisation forms for devices: state registration (IVDs) and entry on the medical device list (equipment and consumables)

pathways.two-device-authorisation-forms

Fact-level verified

Devices manufactured in, imported into, supplied or sold in Mongolia must be registered, save for the statutory exemptions. The Agency grants the registration in two forms — state registration (улсын бүртгэл) or inclusion in the medical device list (эмнэлгийн хэрэгслийн жагсаалт) — taking into account the requirements of Arts. 15.3.1 (proven quality, safety and efficacy) and 15.3.7 (implementation of good reliance practice) and the fact that the device has been placed on the market in the country of manufacture, and on the basis of the Medical Devices Council's decision under Art. 51.1. High- and medium-risk laboratory diagnostic devices are registered in the state register for a period of five years on the basis of the manufacturer's request, the registration documents, an expert opinion and the Council's decision.

Conditions

State registration (улсын бүртгэл) applies to laboratory diagnostic devices; the medical device list (жагсаалт) applies to equipment and consumables — see the separate pathways fact on Art. 33.8.
Registration of high- and medium-risk IVDs is for five years (Art. 33.4).
The classification procedure and list under Art. 33.3 are approved by the head of the Agency.

Source language: Mongolian. Verbatim Art. 33.1: "Монгол Улсад үйлдвэрлэх, импортлох-ханган нийлүүлэх, худалдах эмнэлгийн хэрэгсэл энэ хуулийн 33.9-д зааснаас бусад тохиолдолд бүртгэлтэй байна." Translation: "Medical devices manufactured, imported/supplied or sold in Mongolia shall be registered, except in the cases provided in Article 33.9 of this Law." Verbatim Art. 33.2: "Эм, эмнэлгийн хэрэгслийн асуудал хариуцсан төрийн захиргааны байгууллага энэ хуулийн 33.1-д заасан бүртгэлийг энэ хуулийн 15.3.1, 15.3.7 дахь заалт болон үйлдвэрлэгч улсад зах зээлд гаргасныг харгалзан үзэж, энэ хуулийн 51.1-д заасан Эмнэлгийн хэрэгслийн зөвлөлийн шийдвэрийг үндэслэн дараах хэлбэрээр олгоно: 33.2.1.улсын бүртгэл; 33.2.2.эмнэлгийн хэрэгслийн жагсаалт." Translation: "The State administrative body in charge of medicines and medical devices shall grant the registration provided in Article 33.1 of this Law in the following forms — 33.2.1. state registration; 33.2.2. medical device list — taking into account the provisions of Articles 15.3.1 and 15.3.7 of this Law and the fact that it has been placed on the market in the country of manufacture, and on the basis of the decision of the Medical Devices Council provided in Article 51.1 of this Law."

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Mongolia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Mongolia (6 records)

MongoliaWHO

Prior approval / evidence record

WHO prequalification or the WHO list (medicines route only)

Authority: WHO prequalification or the WHO list (medicines route only)
Accepted: No
Benefit: The accelerated route that names WHO prequalification exists for medicines and is not carried into the device pathway; no device instrument retrieved names WHO, the FDA, the EU, the PMDA or any other authority as a reliance basis for devices. Recorded here so the boundary is visible: for devices the foreign element is documentary only.

Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ БҮРТГЭХ ЖУРАМ (procedure for registering medical devices): IVD state registration, medical device list entry, amendment, renewal and de-listing Эм, эмнэлгийн хэрэгслийн тухай хууль (Law on Medicines and Medical Devices) — Arts. 33 (registration and exemptions), 44 (import declaration), 51 (Medical Devices Council), 58.2 (fees)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MongoliaEurasian Economic Union (EAEU)

Prior approval / evidence record

Mongolia is not a member of the Eurasian Economic Union and applies no regional device recognition

reliance.no-eaeu-or-regional-device-recognition

Fact-level verified

Statement: Mongolia is not a member of the Eurasian Economic Union and therefore does not apply the EAEU's single-market device circulation regime. The EAEU Member-States are Armenia, Belarus, Kazakhstan, the Kyrgyz Republic and the Russian Federation; Mongolia is not among them, and no other regional mutual-recognition arrangement for medical devices covering Mongolia was located.
Source Approval: none
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Regional Bloc
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Established from the EAEU's own official portal listing its Member-States; Mongolia does not appear.
Mongolia is not an ASEAN member, is not in the GCC and is not an EU/EEA state, so no other regional single-market device regime reaches it.

Source language: English (the EAEU portal's English-language page). Verbatim: "The Member-States of the Eurasian Economic Union are the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic and the Russian Federation." Mongolia is not listed. Recorded as a no_reliance_route fact because the customer question for Mongolia is answered in the negative on regional recognition as well as on national recognition.

MongoliaSource authority not specified

Prior approval / evidence record

The Agency may conclude cooperation MoUs with foreign counterpart bodies, but the power creates no device recognition route

reliance.cooperation-mou-power-creates-no-device-route

Fact-level verified

Statement: The Law empowers the Agency to conclude memoranda of understanding on trust with foreign bodies having the same function and with international organisations, to take part in memberships and to cooperate. This is an institutional cooperation power: it establishes no route by which a foreign device approval is recognised or a Mongolian registration facilitated, and no MoU operating as a device recognition route was located.
Source Approval: none (no MoU creating a device recognition route was located)
Edge Type: Cooperation Mou
Market Access Strength: none
Regulatory Layer: institutional
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The power is to establish MoUs, participate in memberships and cooperate — it creates no route, so it is recorded as cooperation_mou with marketAccessStrength 'none' per the contract rule on MoUs.
No MoU operating as a device recognition route was located on mmra.gov.mn or in the legal database.

Source language: Mongolian. Verbatim Art. 50.1.20: "гадаад улсын ижил чиг үүрэг бүхий байгууллага, олон улсын байгууллагатай итгэлцлийн санамж бичиг байгуулах, гишүүнчлэлд хамрагдах, хамтран ажиллах;" Translation: "to conclude memoranda of understanding on trust with bodies of foreign states having the same function and with international organisations, to take part in memberships, and to cooperate;" The same article elsewhere (Art. 50.1.20 context) lists the Agency's other powers; this item is the only foreign-cooperation provision in the Law.

MongoliaSource authority not specified

Prior approval / evidence record

Institutional memoranda of understanding with foreign bodies

Authority: Institutional memoranda of understanding with foreign bodies
Accepted: No
Benefit: Art. 50.1.20 empowers the Agency to conclude trust memoranda with foreign bodies of the same function and with international organisations, but this is a cooperation power: it creates no device route and no such memorandum operating as a recognition route was located.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MongoliaUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval

Authority: FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
Accepted: No
Benefit: Mongolia recognises none of them and names none of them. Art. 33.2 requires the Agency to take into account that the device has been placed on the market in its country of manufacture, Order A/136 §3.6 permits the foreign risk grade to be considered, and Annex Two §§3.9.5 and 3.10.5 require a marketing authorisation or free-sales certificate — but no authority, country or reference list appears anywhere in the Law, in Order A/206 or in Annex Two, the foreign element is evidence of origin-country market placement rather than a recognised authorisation, no clock is shortened, and the Medical Devices Council still takes the decision.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MongoliaSource authority not specified

Prior approval / evidence record

Foreign market placement in the country of manufacture is taken into account, but no foreign approval is recognised and the full local review runs

reliance.origin-country-market-placement-considered

Fact-level verified

Statement: Mongolia operates no recognition route for foreign medical device approvals. Under Art. 33.2 of the Law on Medicines and Medical Devices the Agency grants device registration taking into account the requirements of Arts. 15.3.1 and 15.3.7 and the fact that the device has been placed on the market in the country of manufacture (үйлдвэрлэгч улсад зах зээлд гаргасныг харгалзан үзэж), and on the basis of the Medical Devices Council's decision. The instrument names no foreign regulator, no foreign approval and no reference-country list: the foreign element is evidence of origin-country market placement, not a recognised authorisation. A full Mongolian application, dossier and Council review still run, and the Council retains the decision.
Source Approval: none (no FDA, CE, PMDA, MFDS or NMPA approval is named or recognised; only evidence that the device is placed on the market in its country of manufacture is taken into account)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Art. 15.3.7 (итгэлцлийн зохистой дадлыг хэрэгжүүлэх — implementation of good reliance practice) is a bare statutory principle and establishes no route; it is a consideration the Agency weighs, not a recognition mechanism.
No reference-country, recognised-authority or reliance list for devices exists in the Law, in Order A/206 or in its Annex 2.
The Medical Devices Council decides; the Agency's working office performs the initial analysis and expert opinion.

Source language: Mongolian. Verbatim Art. 33.2: "Эм, эмнэлгийн хэрэгслийн асуудал хариуцсан төрийн захиргааны байгууллага энэ хуулийн 33.1-д заасан бүртгэлийг энэ хуулийн 15.3.1, 15.3.7 дахь заалт болон үйлдвэрлэгч улсад зах зээлд гаргасныг харгалзан үзэж, энэ хуулийн 51.1-д заасан Эмнэлгийн хэрэгслийн зөвлөлийн шийдвэрийг үндэслэн дараах хэлбэрээр олгоно:" Translation: "The State administrative body in charge of medicines and medical devices shall grant the registration provided in Article 33.1 of this Law, taking into account the provisions of Articles 15.3.1 and 15.3.7 of this Law and the fact that it has been placed on the market in the country of manufacture, and on the basis of the decision of the Medical Devices Council provided in Article 51.1 of this Law, in the following forms:" Bounded claim: the text says foreign market placement is 'taken into account' (харгалзан үзэж); it does not name or accept any foreign approval, so this file does not upgrade it to recognition of FDA/CE/PMDA/MFDS/NMPA.

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Working-day stage limits: IVD registration 5+15+30+5 days; device listing 10+10+10 days

timelines.ivd-registration-and-device-list-stage-limits

Fact-level verified

For IVD registration the Agency's working office performs the initial analysis within 5 working days of receiving the documents, the expert produces the conclusion within 15 working days, the matter is submitted to the Medical Devices Council within 30 working days, and the certificate is issued within 5 working days of the Council minutes. For entry of equipment or consumables on the medical device list, the initial analysis and transmission to the Council secretaries is done within 10 working days, the Council decides within 10 working days, and the listing number is issued within 10 working days of the decision. A listing amendment is uploaded to the electronic database within 10 working days of receipt.

Conditions

The applicant has 5 working days to pay after submitting through the E-business system (§2.2).
A de-listing decision is entered in the electronic database within 1 working day; where a decision to reconsider is taken, the Medical Devices Council and the relevant sectoral council consider the matter within 1 month of the required materials being submitted (§2.6).

Source language: Mongolian. Verbatim §2.3: "Ажлын алба нь Е-business цахим системээр ирүүлсэн баримт бичигт ажлын 5 хоногт багтаан анхдагч дүн шинжилгээг хийж, шинжээч нь ажлын 15 хоногт багтаан дүгнэлтийг гаргана." Translation: "The working office shall perform the initial analysis of the documents submitted through the E-business electronic system within 5 working days, and the expert shall produce the conclusion within 15 working days." Verbatim §3.1: "Ажлын алба нь жагсаалтад оруулах хүсэлт бүхий баримт бичгийг хүлээж авснаас хойш ажлын 10 хоногийн дотор анхдагч дүн шинжилгээ хийж Эмнэлгийн хэрэгслийн зөвлөлийн холбогдох салбар зөвлөлийн хуралдаанаар хэлэлцүүлэх хүсэлтийг тухай бүр зөвлөлийн нарийн бичгийн дарга нарт илгээнэ." Translation: "The working office shall, within 10 working days after receiving the documents requesting entry on the list, perform the initial analysis and send the request for discussion at the meeting of the relevant sectoral council of the Medical Devices Council to the council secretaries each time."

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Nine categories of device are exempt from registration, including devices for disaster and public-health emergencies and for personal use

special-access.nine-exempt-categories-and-sale-prohibition

Fact-level verified

Nine categories of medical device do not require registration: low-risk devices other than IIa/IIb/III equipment, consumables and IVDs; spare parts; IVDs supplied under an external quality assessment contract; rare-disease IVDs; devices for research; registration samples; devices for exhibition; devices for use in a disaster or serious public-health situation; and devices received by international post or carried by a passenger for a citizen's personal use. The latter four categories may not be sold. Devices for disaster and public-health emergency use and personal-import devices are therefore exempt from registration but may not be placed on the market commercially.

Conditions

Prohibition on sale applies to the exempt categories in Arts. 33.9.5, 33.9.6, 33.9.7 and 33.9.9 (Art. 33.10).
Under Art. 44.2, devices under Arts. 17.1.7 and 33.9.9 do not require an import declaration at the state border.

Source language: Mongolian. Verbatim Art. 33.9.8: "гамшиг, нийгмийн эрүүл мэндийн ноцтой байдлын үед хэрэглэх эмнэлгийн хэрэгсэл;" Translation: "medical devices for use in a disaster or a serious public-health situation;" Verbatim Art. 33.9.9: "иргэний хувийн хэрэглээний зориулалтаар улс хоорондын шуудан илгээмжээр хүлээн авсан болон зорчигчийн хувийн хэрэглээний эмнэлгийн хэрэгсэл." Translation: "medical devices received by international postal consignment for a citizen's personal use, and medical devices for a passenger's personal use."

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

IVD registration requires ISO 13485 QMS evidence and, where necessary, accredited-laboratory results

standards.iso13485-certified-qms-and-accredited-lab-tests

Fact-level verified

For laboratory diagnostic devices, Order A/206 requires a manufacturer-certified copy of the ISO 13485 quality-management-system certificate, quality-assurance documents including stability data and, where necessary, accredited-laboratory test results.

Conditions

The cited clauses concern laboratory diagnostic devices; renewal documentation also includes the ISO 13485 certificate copy under clause 2.12.2.2.

Mongolian original; the general-device dossier and change procedures are separate and are not inferred from the IVD clauses.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Appeal against a device decision runs through the general administrative-law complaint route

submission.appeal-of-administrative-act-general-administrative-law

Fact-level verified

An applicant may challenge an administrative act of the device regulator by filing a complaint for revision of whether the act is consistent with the law and its designated purposes. The complaint is filed with the higher-level administrative body of the body that issued the act, or with an administrative body charged with reviewing and resolving complaints; where no such body exists it may be filed with the body that issued the act. It must be filed within 30 days of notification of the act, and must be resolved and answered within 30 days, extendable by the management official of the administrative body by up to 30 days with notice to the complainant.

Conditions

This is the general administrative-law remedy, not a device-specific one: the Law on Medicines and Medical Devices and Order A/206 Annex 2 create no separate appeal against a registration, listing or special-permit decision.
The complaint must meet the requirements of Article 10 of the Law on Resolution of Petitions and Complaints filed by Citizens to State Bodies and Officers (Art. 92.2).
Where the statute of limitation is exceeded for compelling reasons, the reviewing body restores it within 3 months after expiry (Art. 94.2).

The legalinfo.mn page for this law publishes the Mongolian text and the publisher's own English translation side by side; both are quoted verbatim below, so no translation of my own is used. The route is recorded here as the general administrative-law remedy, as the round-209 contract directs for this dimension.

Removal decisions may be reconsidered by the Medical Device Council within one month

submission.reconsideration-by-medical-device-council

Fact-level verified

Where a decision is taken to remove a laboratory diagnostic device from the register, the information is entered in the medical device electronic database within 1 working day; where a decision to reconsider (дахин хэлэлцүүлэх) is taken, the matter is considered by the Medical Device Council and the relevant sectoral council within 1 month of the required materials being submitted.

Source language is Mongolian; verbatim passage and English translation below. This is the only reconsideration or re-hearing provision found in the procedure: Annex 2 contains no separate deficiency-response article and no device-specific appeal article, and the listing chapter (Chapter 3) has no equivalent.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Manufacturers must enter the serial number, standard code and quantity of each device batch into the electronic database

traceability.serial-number-standard-code-quantity-in-electronic-register

Fact-level verified

The Law requires the serial number, standard code and quantity of each batch of medicines and medical devices to be entered into the electronic database on each occasion. Entry of the registration or listing in the electronic database is what makes it effective, and the listing metadata recorded for equipment and consumables includes the product name and the instructions for use, held and updated in the electronic information database.

Conditions

Under Annex 2 §2.13, registration or listing takes effect on entry in the electronic database.
Listing metadata is at Annex 2 §§3.7–3.8 (11 fields for medical equipment in §3.7.1–3.7.11 and 13 fields for medical consumables in §3.8.1–3.8.13, each ending with 'Хэрэглэх заавар' — instructions for use).
The obligation is framed as batch-level (цувралын дугаар, стандарт код, тоо хэмжээ) rather than as a UDI-DI/UDI-PI system; no UDI-specific instrument was located.

Source language: Mongolian. Verbatim Art. 11.1.7: "эм, эмнэлгийн хэрэгслийн цувралын дугаар, стандарт код, тоо хэмжээг тухай бүр цахим санд оруулах." Translation: "to enter the serial number, standard code and quantity of each batch of medicines and medical devices into the electronic database on each occasion." No separate UDI regulation was located; whether Mongolia intends a full UDI system is recorded in unresolved.

Related structured datasets

Classification systems · 1 record

Open Mongolian IVD risk grades: low (A), medium (B, C) and high (D) →

mongolia:ivd

Jurisdiction Id

mongolia

Domains

Name

Mongolian IVD risk grades: low (A), medium (B, C) and high (D)

Description

Order A/136 §2.4 of the head of the Medicines and Medical Devices Control and Regulatory Agency writes the four IVD classes as three risk grades, verbatim: 'Лабораторийн оношилгооны хэрэгслийг эрсдэлийн зэргээр бага (A), дунд (B, C), өндөр (D) эрсдэлтэй гэж ангилна' — low (A), medium (B and C), high (D). The grade word is the Order's own risk descriptor and the class letter subdivides it, so the two medium classes carry the identical descriptor: the classification rules repeat one grade word over both, most directly at §§5.4.1 and 5.4.2, adjacent rules in the same subsection that send self-testing devices to 'дунд эрсдэлтэй буюу B зэрэгт хамаарна' and 'дунд эрсдэлтэй буюу C зэрэгт хамаарна' (and §5.3.7 likewise to 'дунд эрсдэлтэй буюу C зэрэгт хамаарна'). B and C are therefore distinguished only by which rule applies, and the Order gives neither a risk word of its own. §2.6 resolves a device falling within two or more grades by entering it in the list of the highest grade. Classification is applied through the classification list built on the GMDN nomenclature (§3.1), and the classification procedure and list are approved by the Agency head under Art. 33.3 of the Law on Medicines and Medical Devices.

Classes

Id
a
Label
Class A (бага эрсдэлтэй)
Normalized Risk Level
low
Id
b
Label
Class B (дунд эрсдэлтэй)
Normalized Risk Level
medium
Id
c
Label
Class C (дунд эрсдэлтэй)
Normalized Risk Level
medium
Id
d
Label
Class D (өндөр эрсдэлтэй)
Normalized Risk Level
high

Regulator

Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар (Medicines and Medical Devices Control and Regulatory Agency), abbreviated ЭЭХХЗГ

Official Domains

mmra.gov.mn
legalinfo.mn

Source Status

official-source-verified

Reference Sources

Title
Order A/136 §3.1 — the classification list is built on the international GMDN nomenclature
Url
https://mmra.gov.mn/Files/%D0%AD%D0%A2%D0%A2%D0%93/%D0%90136.pdf
Reviewed On
2026-09-16
Supports
The grade is assigned per GMDN entry, so a Mongolian class cannot be derived from the product name alone; the list is the operative instrument and the procedure is the rule set behind it.
Title
Эм, эмнэлгийн хэрэгслийн тухай хууль (Law on Medicines and Medical Devices), Art. 33.3
Url
https://legalinfo.mn/mn/detail?lawId=17140713569541
Reviewed On
2026-09-16
Supports
The statutory delegation: the classification procedure and the classification list are approved by the head of the Agency, not by the Law or by ministerial order, which is why this scheme is bound to Order A/136.

Source Title

Эмнэлгийн хэрэгслийг эрсдэлийн зэргээр ангилах журам (procedure for classifying medical devices by risk grade), approved by Order A/136 of the head of the Medicines and Medical Devices Control and Regulatory Agency, 4 August 2026 — §2.4

Source Url

https://mmra.gov.mn/Files/%D0%AD%D0%A2%D0%A2%D0%93/%D0%90136.pdf

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Mongolia registration →

Country

Mongolia

Jurisdiction Id

mongolia

Country Code

Flag

🇲🇳

Regulator

Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар (Medicines and Medical Devices Control and Regulatory Agency), a Government implementing agency within the portfolio of the Minister of Health, with the Medical Devices Council seated at the health ministry as the deciding body

Regulator Abbrev

Medicines and Medical Devices Regulatory Agency (MMRA)

Region

asia-pacific

Tier

Risk Classification

4 national grades: equipment and consumables low (I), medium (IIa, IIb), high (III); IVDs low (A), medium (B, C), high (D) — Order A/136 §§2.2, 2.4, approved under Law Art. 33.3

Classes

Id
ivd-state-registration
Class Name
Laboratory diagnostic devices (IVD) of medium and high risk (classes B, C, D) — state registration with a 5-year certificate
Pathway
Registration dossier filed with the Agency through the E-business system, initial analysis and expert opinion by the working office, decision by the Medical Devices Council, certificate signed by the Agency head
Official Timeline
Min
55
Max
55
Unit
working-days
Verification Status
official-verified
Official Source
Title
Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ БҮРТГЭХ ЖУРАМ (procedure for registering medical devices): IVD state registration, medical device list entry, amendment, renewal and de-listing
Url
https://legalinfo.mn/mn/detail?lawId=17431734185862
Accessed Date
2026-09-16
Realistic Timeline
Min
3
Max
6
Notes
Official clock: 55 working days is the sum of the published stage limits in Annex Two §§2.3 to 2.5 — initial analysis within 5 working days, expert opinion within 15 working days, tabling at the Medical Devices Council within 30 working days of the expert opinion, and issue of the certificate within 5 working days of the Council minutes. The instrument states each limit against its own triggering event and does not say the stages run back to back, so this is the sum of the limits rather than a guaranteed end-to-end period.
The applicant's own clock runs alongside: after filing through the E-business system the registrant has 5 working days to pay the registration fee (§2.2), and the procedure makes the applicant responsible for the accuracy and completeness of the submission and for paying the fee in the period demanded (§§2.4 in the listing section, 3.4).
The instrument sets no bound on when the Medical Devices Council itself meets; the 30 working days covers the working office's action to bring the matter before it.
Registration is valid for 5 years and is renewable; the renewal request and the full dossier must be filed at least 2 months before expiry, and a device whose renewal is not filed is treated as unregistered from the expiry date (§§1.3, 2.9, 2.10).
Batch-level traceability, not UDI: the device information must be entered into the electronic device database for the registration to take effect (§2.13), and Art. 11.1.7 requires the batch serial number, standard code and quantity to be entered there.
Class A (low-risk) IVDs are outside this row: Art. 33.9.1 exempts laboratory diagnostic devices other than high- and medium-risk ones from registration, so the IVD registration clock covers classes B, C and D.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
medical-equipment-and-consumables-list-entry
Class Name
Medical equipment and medical consumables of medium and high risk (grades IIa, IIb, III) — entry on the medical device list
Pathway
Listing dossier to the Agency; initial analysis within 10 working days, sub-council opinion and referral within 10 working days, Medical Devices Council decision and issue of a registration number within 10 working days
Official Timeline
Min
30
Max
30
Unit
working-days
Verification Status
official-verified
Official Source
Title
Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ БҮРТГЭХ ЖУРАМ (procedure for registering medical devices): IVD state registration, medical device list entry, amendment, renewal and de-listing
Url
https://legalinfo.mn/mn/detail?lawId=17431734185862
Accessed Date
2026-09-16
Realistic Timeline
Min
4
Max
8
Notes
Official clock: three consecutive 10-working-day stages in Annex Two section three — the working office completes the initial analysis of the listing request and sends it to the sub-council secretaries (§3.1), the request is brought to the Medical Devices Council within 10 working days of the sub-council's opinion (§3.2), and a registration number is issued and entered in the electronic system within 10 working days of the Council's decision (§3.3). 30 working days is the sum of the three published limits.
The three stages are anchored to events the instrument does not itself time — receipt of the request, the sub-council's opinion and the Council's decision — so the sum is the published stage budget, not a promise of 30 working days end to end.
Art. 33.8 requires the list entry to identify the device per country, manufacturer and model; Annex Two §3.5 gives list entries an FMD (foreign) or LMD (local) marker, the five-digit international nomenclature (GMDN) code and a five-digit list number.
ISO 13485 certification of the manufacturer's quality management system is a mandatory dossier item (§§3.9.4, 3.10.4) and the manufacturer's original letter designating the Mongolian supplying organisation is required for equipment and consumables alike (§§3.9.12, 3.10.12) — a documentary QMS requirement, not a manufacturing-site audit; whether the Agency audits foreign sites is unresolved.
No clinical investigation and no local testing are required by the procedure read; where needed, results from a national accredited laboratory or the national reference laboratory are filed instead (§§2.12.1.10, 2.12.3.5).
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
device-list-amendment
Class Name
Amendment of an existing medical device list entry (manufacturer, labels, packaging or stability change)
Pathway
Amendment request to the Agency with the changed labelling artwork, risk assessment, stability data or the manufacturer's old and new ISO certificates, as applicable
Official Timeline
Min
10
Max
10
Unit
working-days
Verification Status
official-verified
Official Source
Title
Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ БҮРТГЭХ ЖУРАМ (procedure for registering medical devices): IVD state registration, medical device list entry, amendment, renewal and de-listing
Url
https://legalinfo.mn/mn/detail?lawId=17431734185862
Accessed Date
2026-09-16
Realistic Timeline
Min
1
Max
3
Notes
Official clock: within 10 working days of receiving a request to change the information of a listed device, the working office updates the electronic database by its own decision (Annex Two §3.6).
Annex Two §3.6 names only listed equipment and consumables; §2.12.3 sets no clock for amendments to a registered IVD.
The dossier for an amendment is enumerated in §2.12.3 for registered IVDs and §3.11 for listed equipment and consumables (comparative old/new labelling artwork, an explanation of the change, risk-assessment and stability reports where the change touches the valid term, and the manufacturer's old and new ISO certificates where the name or address changes).
The same 10-working-day limit covers amendments to listed equipment and consumables (§3.6) and to registered IVDs, so the row is a route-wide clock rather than one tied to a single risk grade.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
statutory-exempt-categories
Class Name
Low-risk devices (grade I equipment and consumables, class A IVDs) — no registration and no list entry under Art. 33.9.1
Pathway
Statutory exemption under Art. 33.9; an import declaration per consignment still applies to the Art. 33.9.1 to 33.9.8 categories
Official Timeline
Min
0
Max
0
Unit
days
Verification Status
official-verified
Official Source
Title
Эм, эмнэлгийн хэрэгслийн тухай хууль (Law on Medicines and Medical Devices) — Arts. 33 (registration and exemptions), 44 (import declaration), 51 (Medical Devices Council), 58.2 (fees)
Url
https://legalinfo.mn/mn/detail?lawId=17140713569541
Accessed Date
2026-09-16
Realistic Timeline
Min
0
Max
0
Notes
Verified negative, not an estimate: Art. 33.1 makes devices registered except in the cases in Art. 33.9, and Art. 33.9.1 excludes devices other than high- and medium-risk medical equipment, medical consumables and laboratory diagnostic devices. A grade I device therefore has no application to file and the instruments fix no clock for it, which is why the row carries a published zero.
The other exempt categories are equipment spare parts and consumables needed for normal operation (33.9.2), laboratory diagnostics supplied under an agreement with an international external-quality-control body (33.9.3), orphan devices for rare diseases (33.9.4), research, training and clinical-trial devices (33.9.5), registration samples (33.9.6), exhibition devices (33.9.7), disaster and public-health-emergency devices (33.9.8), and personal-use devices received by international mail or carried by travellers (33.9.9).
The exemption is not licence to sell: Art. 33.10 prohibits the sale of devices in categories 33.9.5, 33.9.6, 33.9.7 and 33.9.9.
An import declaration is still required for each consignment of the 33.9.1 to 33.9.8 categories (Art. 44.1.4); only the personal-use category in Art. 33.9.9 is exempt from it (Art. 44.2).
This row is linked to the low-risk grade because Art. 33.9.1 is class-drawn; the situational categories in Art. 33.9.2 to 33.9.9 are not, and can cover a medium- or high-risk device (an orphan device or an emergency import, for instance) without any registration.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval
Accepted
No
Benefit
Mongolia recognises none of them and names none of them. Art. 33.2 requires the Agency to take into account that the device has been placed on the market in its country of manufacture, Order A/136 §3.6 permits the foreign risk grade to be considered, and Annex Two §§3.9.5 and 3.10.5 require a marketing authorisation or free-sales certificate — but no authority, country or reference list appears anywhere in the Law, in Order A/206 or in Annex Two, the foreign element is evidence of origin-country market placement rather than a recognised authorisation, no clock is shortened, and the Medical Devices Council still takes the decision.
Authority
WHO prequalification or the WHO list (medicines route only)
Accepted
No
Benefit
The accelerated route that names WHO prequalification exists for medicines and is not carried into the device pathway; no device instrument retrieved names WHO, the FDA, the EU, the PMDA or any other authority as a reliance basis for devices. Recorded here so the boundary is visible: for devices the foreign element is documentary only.
Authority
Institutional memoranda of understanding with foreign bodies
Accepted
No
Benefit
Art. 50.1.20 empowers the Agency to conclude trust memoranda with foreign bodies of the same function and with international organisations, but this is a cooperation power: it creates no device route and no such memorandum operating as a recognition route was located.

Key Requirements

File the registration or listing dossier with the Agency through the E-business electronic system and pay the applicable fee within 5 working days of filing (Annex Two §2.2); the applicant is responsible for the accuracy and completeness of the submission and for paying the fee in the period demanded (§§2.12, 3.4).
The application is lodged by the manufacturer, the Mongolian supplying organisation (ханган нийлүүлэх байгууллага) or the manufacturer's official representative (үйлдвэрлэгчийн албан ёсны төлөөлөгч) (Annex Two §2.12).
An original letter from the manufacturer designating the Mongolian supplying organisation, identifying the functions under Art. 40.8, is a mandatory dossier item for equipment and consumables listing (Annex Two §§3.9.12, 3.10.12).
ISO 13485 certificate for the manufacturer's quality management system, in a certified copy (Annex Two §§2.12.1.3, 3.9.4, 3.10.4).
Origin-country evidence that the product may be placed on the market: a marketing authorisation or free-sales certificate (Annex Two §§3.9.5, 3.10.5). No country or authority is named, so any origin country's document satisfies it, and it confers no shortened route.
For IVDs, evidence from the country of origin that the product falls in the 'laboratory diagnostic device' category, which does not apply to nationally manufactured IVDs (Annex Two §2.12.1.4).
Classification per the Agency head's risk-grade procedure and list built on the international GMDN nomenclature (Order A/136 §§2.2, 2.4, 3.1, under Law Art. 33.3).
The Medical Devices Council seated at the health ministry takes the registration, listing and de-listing decision; the Agency's working office performs the initial analysis and the expert opinion and acts as the Council's working office (Law Arts. 33.2, 51.1, 51.2; Annex Two §1.2).
Registration and listing take effect when the applicant enters the device information into the electronic device database (Annex Two §2.13); listing entries carry an FMD or LMD marker, the five-digit GMDN code and a five-digit list number (§3.5).
IVD registration runs for 5 years; the renewal request with market-surveillance and user-survey evidence and the full dossier must be filed at least 2 months before expiry (Annex Two §§1.3, 2.9, 2.11).
A separate import declaration is required for each consignment (Law Art. 44.1), carrying the product name, form, model, quantity, batch number, manufacturer and border-crossing period (Art. 44.3); it is not required for the personal-use category (Art. 44.2).
Batch serial number, standard code and quantity must be entered in the electronic database (Law Art. 11.1.7) — traceability is batch-level; no UDI instrument was located.

Local Rep Required

Yes

Local Rep Name

Supplying organisation (ханган нийлүүлэх байгууллага) or the manufacturer's official representative (үйлдвэрлэгчийн албан ёсны төлөөлөгч)

Mdsap Accepted

Mdsap Benefit

No MDSAP or reliance route exists. The ISO 13485 certificate is a mandatory dossier item in the IVD registration and in the equipment and consumables listing (Annex Two §§2.12.1.3, 3.9.4, 3.10.4) but buys no timeline reduction, and no audit report is accepted in place of it.

Registration Validity

5 years for the state registration of laboratory diagnostic devices (IVD), renewable on a request filed at least 2 months before expiry (Annex Two §§1.3, 2.9, 2.10); a medical device list entry continues until it is amended or removed (§3.6)

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — ЭМНЭЛГИЙН ХЭРЭГСЛИЙГ БҮРТГЭХ ЖУРАМ (procedure for registering medical devices): IVD state registration, medical device list entry, amendment, renewal and de-listing
Url
https://legalinfo.mn/mn/detail?lawId=17431734185862
Accessed Date
2026-09-16
Title
Эм, эмнэлгийн хэрэгслийн тухай хууль (Law on Medicines and Medical Devices) — Arts. 33 (registration and exemptions), 44 (import declaration), 51 (Medical Devices Council), 58.2 (fees)
Url
https://legalinfo.mn/mn/detail?lawId=17140713569541
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Medicines and Medical Devices Regulatory Agency (MMRA). Appoint a Supplying organisation (ханган нийлүүлэх байгууллага) or the manufacturer's official representative (үйлдвэрлэгчийн албан ёсны төлөөлөгч).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Medicines and Medical Devices Regulatory Agency (MMRA) including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Medicines and Medical Devices Regulatory Agency (MMRA) reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Medicines and Medical Devices Regulatory Agency (MMRA) may issue questions.
Duration
55 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Medicines and Medical Devices Regulatory Agency (MMRA) issues Mongolia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Mongolia fees →

Jurisdiction Id

mongolia

Country

Mongolia

Country Code

Authority

Ministry of Health / Medical Device and Medical Equipment Regulatory Agency (MMRA); State Stamp Duty administered under the Law on State Stamp Duty

Low Risk Local

Min: 44000
Max: 200000
Currency: MNT
Per Product: No

High Risk Local

Min: 44000
Max: 200000
Currency: MNT
Per Product: No

Details

Id
special-permit-manufacture-export
Item
Special permit to manufacture and export medicines, medical equipment, laboratory diagnostic devices and medical supplies
Currency
MNT
Amount Local
44000
Amount Local Min
44000
Amount Local Max
110000
Amount Local Formatted
MNT 44,000–110,000
Frequency
Per permit issued
Notes
Article 27.1.1 of the Law on State Stamp Duty, as re-drafted by the law of 5 June 2024. The item expressly names 'эмнэлгийн тоног төхөөрөмж' (medical equipment), 'лабораторийн оношилгооны хэрэгсэл' (laboratory diagnostic devices) and 'эмнэлгийн хэрэглэгдэхүүн' (medical supplies). Government Resolution No. 173 fixes 110,000 MNT inside this band for the combined manufacture/sale/import permit as it stood before the 2024 split.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://legalinfo.mn/mn/detail/515
Source Title
Улсын тэмдэгтийн хураамжийн тухай хууль (Law on Mongolia on State Stamp Duty), Article 27 'Эрүүл мэндийн чиглэлээр эрхлэх үйл ажиллагаанд зөвшөөрөл олгоход хураах тэмдэгтийн хураамжийн хэмжээ', items 27.1.1-27.1.3 as re-drafted by the law of 5 June 2024
Source Effective Date
2024-06-05
Verified On
2026-09-16
Id
special-permit-import-supply
Item
Special permit to import and supply medicines, medical equipment, laboratory diagnostic devices and medical supplies
Currency
MNT
Amount Local
50000
Amount Local Min
50000
Amount Local Max
200000
Amount Local Formatted
MNT 50,000–200,000
Frequency
Per permit issued
Notes
Article 27.1.2 — the item that reaches a foreign manufacturer's Mongolian importer. The band is statutory; the point inside it is not established, because Government Resolution No. 173 was made against the pre-2024 wording in which manufacture, sale and import were a single item, and no later resolution matching the split wording was located. This is not a registration fee for a device product; the product-registration fee power under Article 58.2 of the Law on Medicines and Medical Devices is still a draft and charges nothing today.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://legalinfo.mn/mn/detail/515
Source Title
Улсын тэмдэгтийн хураамжийн тухай хууль (Law on Mongolia on State Stamp Duty), Article 27 'Эрүүл мэндийн чиглэлээр эрхлэх үйл ажиллагаанд зөвшөөрөл олгоход хураах тэмдэгтийн хураамжийн хэмжээ', items 27.1.1-27.1.3 as re-drafted by the law of 5 June 2024
Source Effective Date
2024-06-05
Verified On
2026-09-16
Id
special-permit-sale
Item
Special permit to sell medicines and medical devices
Currency
MNT
Amount Local
44000
Amount Local Min
44000
Amount Local Max
110000
Amount Local Formatted
MNT 44,000–110,000
Frequency
Per permit issued
Notes
Article 27.1.3, which expressly names 'эмнэлгийн хэрэгсэл' (medical devices) and narcotic drugs. Same band-and-resolution structure as item 27.1.1; same limitation on the point inside the band.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://legalinfo.mn/mn/detail/515
Source Title
Улсын тэмдэгтийн хураамжийн тухай хууль (Law on Mongolia on State Stamp Duty), Article 27 'Эрүүл мэндийн чиглэлээр эрхлэх үйл ажиллагаанд зөвшөөрөл олгоход хураах тэмдэгтийн хураамжийн хэмжээ', items 27.1.1-27.1.3 as re-drafted by the law of 5 June 2024
Source Effective Date
2024-06-05
Verified On
2026-09-16
Id
resolution-combined-permit
Item
State stamp duty — combined manufacture, sale and import permit for medicines, medical devices, instruments, equipment, prostheses and orthopaedics
Currency
MNT
Amount Local
110000
Amount Local Formatted
MNT 110,000
Frequency
Per permit issued
Notes
Annex item 13.1.1 of Government Resolution No. 173 of 9 May 2023, the operative figure for the permits Article 27.1.1, 27.1.4, 27.1.5 and 27.1.6 leave open. Read it as the fixed amount for the combined permit as it stood in 2023: the 5 June 2024 law split that permit into manufacture-export, import-supply and sale. Later amendments to the resolution's annex were not verified this round.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://legalinfo.mn/mn/detail/16759311152511
Source Title
Government Resolution No. 173 of 9 May 2023 'Улсын тэмдэгтийн хураамжийн хувь, хэмжээг тогтоох тухай', Annex 'ТЭМДЭГТИЙН ХУРААМЖИЙН ХУВЬ, ХЭМЖЭЭ' Chapter Thirteen, items 13.1.1 and 13.4 (repealed Government Resolution No. 199 of 29 June 2011)
Source Effective Date
2023-05-09
Verified On
2026-09-16

Notes

Mongolia charges device companies through the state stamp duty on the health-sector activity permits they must hold, not through a risk-classed product-registration tariff. The three statutory items (27.1.1 manufacture-export, 27.1.2 import-supply, 27.1.3 sale) each name medical devices expressly, and Government Resolution No. 173 of 9 May 2023 fixes 110,000 MNT inside the band for the permits it covers.
The permit is activity-based, so the two risk-keyed headline bands show the same statutory span (MNT 44,000–200,000, per permit) rather than a low/high split; the per-item bands are in the rows above.
A device product-registration fee is implementation-pending, not zero: Article 58.2 of the Law on Medicines and Medical Devices creates the power and the joint procedure of the Ministers of Health and of Finance and Budget was still out for public comment on the Ministry of Health's site (notice of 29 April 2026) and the regulator's site (notice of 8 January 2025), with no adopted joint order found. Budget separately from the permit duties above.
This falsifies the round-205 finding that Mongolia publishes no device-named fee amount. It does, and the amounts are in force.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Улсын тэмдэгтийн хураамжийн тухай хууль (Law on Mongolia on State Stamp Duty), Article 27 'Эрүүл мэндийн чиглэлээр эрхлэх үйл ажиллагаанд зөвшөөрөл олгоход хураах тэмдэгтийн хураамжийн хэмжээ', items 27.1.1-27.1.3 as re-drafted by the law of 5 June 2024
Url
https://legalinfo.mn/mn/detail/515
Effective Date
2024-06-05
Accessed Date
2026-09-16
Title
Government Resolution No. 173 of 9 May 2023 'Улсын тэмдэгтийн хураамжийн хувь, хэмжээг тогтоох тухай', Annex 'ТЭМДЭГТИЙН ХУРААМЖИЙН ХУВЬ, ХЭМЖЭЭ' Chapter Thirteen, items 13.1.1 and 13.4 (repealed Government Resolution No. 199 of 29 June 2011)
Url
https://legalinfo.mn/mn/detail/16759311152511
Effective Date
2023-05-09
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Mongolia certifications →

Slug

mongolia

Market

Mongolia

Confidence

low

Schemes

Id
mongolia-crc-ict-type-approval
Name
CRC type approval and conformity mark for information and communication equipment
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio And Terminal Equipment
Note
The CRC's certification page divides certification into заавал (mandatory) and сайн дурын (voluntary) and states that information and communication equipment — network and terminal equipment — on the list approved by Annex 1 of Government Resolution No. 291 of 2018 ('Тохирлын баталгаанд заавал хамруулах бүтээгдэхүүн, үйлчилгээний жагсаалт') must be certified, while industrial and household electrical equipment outside that list may be certified voluntarily; the CRC's register of approved procedures identifies the governing instruments as 'THE TYPE APPROVAL REGULATORY GUIDELINE FOR THE INFORMATION AND COMMUNICATION EQUIPMENT', Resolution No. 29 of 2019, and the conformity-mark guidance, Resolution No. 43 of 2019 (CHTJ010-2019). The application file requires the manufacturer's or supplier's declaration of conformity, the manufacturer's or supplier's authorisation, and test results produced within the previous six years covering health and safety, electromagnetic compatibility (EMC) and radio spectrum (RF), with the equipment's frequency band, output power, modulation type, channel spacing and antenna gain; the CRC certifies that the equipment meets the standard requirements, does not affect human health adversely and does not interfere with other networks, and issues a conformity certificate after its non-staff Certification Assessment Committee decides, notifying the applicant within 5 working days of the decision. The certificate is issued under the conformity-mark procedure and the holder may apply the mark. The fee is set by the annex to Board Resolution No. 13 of 28 February 2020 ('Мэдээлэл, харилцаа холбооны тоног төхөөрөмжид баталгаажуулалт хийх төлбөрийн хэмжээ') and varies by assessment scheme. Two limits on this row: the guideline text and the Annex 1 list itself were not retrieved (the register page carries no per-document link and new.crc.gov.mn did not resolve), so whether a given radio-equipped medical device falls on the mandatory list is not established here; and the mandatory character and the document list are asserted on the CRC's own published pages, which are what this row is bound to.
Source Urls
https://admin.crc.gov.mn/pages/show/directions-terms-and-requirements-of-procedures-and-regulations-approved-by-the-crc/en
https://admin.crc.gov.mn/articles/slug32/mn
Source Binding
reviewed
Id
mongolia-metrology-measuring-instrument-type-approval
Name
Legal metrology: type approval, state-database registration and verification of measuring instruments
Category
Legal Metrology
Status
Mandatory If Feature
Object
Measuring Instrument
Note
The Law on Metrology brings measuring instruments used in the diagnosis and treatment of humans inside legal metrology (Art. 8.1.1). Such an instrument is type-tested (Art. 9.1), registered in the state integrated database of measuring instruments with a type-approval certificate (Art. 9.4), and the procedure is adopted by the state administrative body in charge of metrology (Art. 9.6). Art. 9.7 permits OIML or foreign test results to be recognised without repeat testing. The instrument does not name the body that holds the metrology remit, so the row states the statutory function rather than an authority abbreviation; see unresolved.
Source Urls
https://legalinfo.mn/mn/edtl/16758294439801
Source Binding
reviewed
Id
mongolia-nuclear-energy-radiation-generator-licence
Name
Licence for radiation generators: possession, use, sale, transport, import and export
Category
Ionizing Radiation
Status
Mandatory If Feature
Object
Radiation Generator
Note
Art. 15.3 of the Nuclear Energy Law requires a licence to possess, exploit and sell radiation generators (15.3.1), to carry out other licensed activities with them (15.3.2) and to transport, import and export them (15.3.3). Diagnostic X-ray, fluoroscopy and radiotherapy equipment fall on their face within 'radiation generators', so a device of that kind carries a separate licence in addition to registration. The licensing body is written in the retrieved English text as the state central administrative body in charge of education.
Source Urls
https://legalinfo.mn/en/edtl/16532634283141
Source Binding
reviewed
Id
mongolia-per-consignment-import-declaration
Name
Per-consignment import declaration for registered medical devices
Category
Import Conformity
Status
Mandatory At Import
Object
Registered Medical Device
Note
Art. 44.1 of the Law on Medicines and Medical Devices requires the Agency to issue an import declaration for each consignment of medicines and medical devices; Art. 44.1.4 covers products in the Art. 33.9.1 to 33.9.8 categories and Art. 44.1.3 covers import of registered devices by a supplying organisation. Art. 44.2 removes the declaration only for the personal-use category in Art. 33.9.9. The declaration carries the product name, form, model, quantity, batch number, manufacturer and border-crossing period (Art. 44.3), so it is the customs-facing control rather than a second approval.
Source Urls
https://legalinfo.mn/mn/detail?lawId=17140713569541
Source Binding
reviewed
Id
mongolia-electrical-safety-and-emc
Name
Electrical safety and EMC evidence inside the device registration dossier
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Medical Electrical Equipment
Note
No separate Mongolian electrical-safety or EMC certificate for medical devices was located in the instruments read; the evidence enters through the registration dossier instead. Annex Two to Order A/206 requires a verification report showing by various test methods that the device meets its technical specifications (§§3.9.11, 3.10.10, and for IVDs §2.12.1.10 in the amendment dossier), together with the manufacturer's quality-management certificate under ISO 13485 (§§2.12.1.3, 3.9.4, 3.10.4) and, where the Agency requires it, test results from an accredited laboratory or from the national reference laboratory for medicines and medical devices (§§2.12.3.5, and the stages in §2.1 which include professional accredited-laboratory testing where required). For a device that is also information and communication equipment, the CRC type-approval row above separately requires test results covering health and safety, EMC and RF produced within the previous six years, so EMC evidence can be demanded in both files for the same product. Whether a general product-safety or standardisation instrument imposes a separate electrical-safety certificate on medical electrical equipment is unresolved; nothing beyond the dossier requirement is asserted here.
Source Urls
https://legalinfo.mn/mn/detail?lawId=17431734185862
Source Binding
reviewed

Official Sources

Authority
Communications Regulatory Commission of Mongolia (ХХЗХ)
Topic
register of directions, terms and requirements of procedures approved by the CRC — ICT type-approval guideline (Resolution No. 29 of 2019) and conformity-mark guidance (Resolution No. 43 of 2019, CHTJ010-2019)
Url
https://admin.crc.gov.mn/pages/show/directions-terms-and-requirements-of-procedures-and-regulations-approved-by-the-crc/en
Authority
Communications Regulatory Commission of Mongolia (ХХЗХ)
Topic
Баталгаажуулалт (certification) page — mandatory certification for equipment on the Annex 1 list to Government Resolution No. 291 of 2018, application documents including six-year health/safety, EMC and RF test results, the 5-working-day decision notice, the conformity mark and the scheme-dependent fee annex to Board Resolution No. 13 of 2020 (Mongolian)
Url
https://admin.crc.gov.mn/articles/slug32/mn
Authority
Medicines and Medical Devices Control and Regulatory Agency (ЭЭХХЗГ)
Topic
Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — medical device registration procedure: dossier items including the verification report and ISO 13485 certificate, list-entry stages and the import-adjacent controls
Url
https://legalinfo.mn/mn/detail?lawId=17431734185862
Authority
Medicines and Medical Devices Control and Regulatory Agency (ЭЭХХЗГ)
Topic
Law on Metrology — type approval, state-database registration and verification of measuring instruments, including instruments used in the diagnosis and treatment of humans
Url
https://legalinfo.mn/mn/edtl/16758294439801
Authority
Medicines and Medical Devices Control and Regulatory Agency (ЭЭХХЗГ)
Topic
Law on Medicines and Medical Devices — device registration and listing, exempt categories and the per-consignment import declaration (Arts. 33, 44)
Url
https://legalinfo.mn/mn/detail?lawId=17140713569541
Authority
State central administrative body in charge of education (nuclear energy)
Topic
Nuclear Energy Law — licences to possess, exploit, sell, transport, import and export radiation generators (Art. 15.3)
Url
https://legalinfo.mn/en/edtl/16532634283141

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Confirm the current Medicines and Medical Devices Regulatory Agency (MMRA) pathway, evidence, and local-role details for the actual device before filing.

Pricing

Changes after registration

Approval validity & renewal

IVD registration and certificate are valid for five years; renewal must be requested two months before expiry

Authority & regime

The Agency's published structure includes a dedicated Medical Equipment Division

Change control

Amendments require a five-item dossier for IVDs; listed equipment and consumables are updated in the electronic database

Classification rules

The foreign risk class may permissively be taken into account when classifying a device

Devices classified into three risk grades (I, IIa/IIb, III); IVDs into four classes (A, B, C, D)

Clinical investigation & performance

Clinical evaluation and study results are a mandatory IVD registration dossier item

Device definition & scope

Law covers human medicines, medical devices and health supplements; veterinary products excluded

Dossier requirements

Ten-item IVD registration dossier including ISO 13485, performance and stability data, clinical evaluation results and Mongolian-labelled IFU

Economic-operator roles

Registration and listing are filed by the manufacturer, a supplying organisation or the manufacturer's official representative

Establishment, import & distribution

Import-supply permit condition: premises and staffing meeting the storage-and-distribution standard

Import-supply special permit is required to import and supply medical devices

Import-supply permit holder must supply wholesale to health organisations and pharmacies and may not handle unregistered devices

Label, IFU & language

IVD and equipment instructions for use must be in Mongolian; the equipment user manual and device labels may be Mongolian or English

Legal basis & guidance

Registration procedure adopted by Minister of Health Order No. A/206; Annex 2 governs medical devices

Law on Medicines and Medical Devices (revised edition, 5 June 2024); registration procedure delegated to the Minister of Health

Manufacturer PMS

The supplying organisation must conduct surveillance on the devices it supplies, bear testing costs and recall non-conforming devices

Official forms & portals

IVD registration applications are filed through the E-business electronic system

QMS, audit & inspection

State inspectors inspect device quality and safety and may inspect without a warrant on serious-risk findings

Manufacturer's ISO 13485 certificate is the QMS evidence required for device listing

Recall, FSCA & market surveillance

Recall deadlines of 24 hours, 72 hours or 14 days by severity; the supplying organisation bears the cost

Registration pathways

Medical device list is per-manufacturer, per-model or per-product number; nine categories are exempt from registration

Two authorisation forms for devices: state registration (IVDs) and entry on the medical device list (equipment and consumables)

Reliance & recognition

Mongolia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Mongolia (6 records)

WHO prequalification or the WHO list (medicines route only)

Mongolia is not a member of the Eurasian Economic Union and applies no regional device recognition

The Agency may conclude cooperation MoUs with foreign counterpart bodies, but the power creates no device recognition route

Institutional memoranda of understanding with foreign bodies

FDA 510(k)/PMA, EU CE marking, Japan PMDA, Korea MFDS, China NMPA or any other foreign device approval

Foreign market placement in the country of manufacture is taken into account, but no foreign approval is recognised and the full local review runs

Review clocks

Working-day stage limits: IVD registration 5+15+30+5 days; device listing 10+10+10 days

Special access & derogation

Nine categories of device are exempt from registration, including devices for disaster and public-health emergencies and for personal use

Standards, testing & ancillary approvals

IVD registration requires ISO 13485 QMS evidence and, where necessary, accredited-laboratory results

Submission communications & appeal

Appeal against a device decision runs through the general administrative-law complaint route

Removal decisions may be reconsidered by the Medical Device Council within one month

UDI, listing & traceability

Manufacturers must enter the serial number, standard code and quantity of each device batch into the electronic database

Related structured datasets

More Mongolia medical device resources