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Medicines and Medical Devices Regulatory Agency (MMRA) · East Asia & Pacific

Mongolia medical device regulatory resources

Every Mongolia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 topics with records4 regulations trackedSep 2026 fees reviewed
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AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Mongolia requirements.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Medical device regulations

Browse Mongolia's official medical-device instruments — the revised Law on Medicines and Medical Devices, the registration procedure, and the agency's founding resolution and ministerial order — with citeable Mongolian passages.

Government registration fees

Review the state stamp duty on Mongolian medical-device activity permits, and the product-registration fee position.

Structured regulatory requirements

Explore all 40 source-linked facts →

24 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
The Agency's published structure includes a dedicated Medical Equipment Division
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 газа…
A Medical Devices Council seated at the health ministry decides device registration and listing
The Law establishes that a Pharmaceutical Council and a Medical Devices Council operate respectively at the central administrative body in charge of health. The Medical Devices Council is a…
3 source-linked facts
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Registration procedure adopted by Minister of Health Order No. A/206; Annex 2 governs medical devices
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 supplem…
Law on Medicines and Medical Devices (revised edition, 5 June 2024); registration procedure delegated to the Minister of Health
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 202…
2 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
Law covers human medicines, medical devices and health supplements; veterinary products excluded
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 dev…
1 source-linked fact
Checked 2026-09-16
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D04

Classification rules

Verified
Mongolian risk grades: low (I), medium (IIa, IIb) and high (III)
Grade I (бага эрсдэлтэй), Grade IIa (дунд эрсдэлтэй), Grade IIb (дунд эрсдэлтэй), Grade III (өндөр эрсдэлтэй)
1 maintained scheme · 2 related facts
Checked 2026-09-16
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D05

Registration pathways

Verified
Medical device list is per-manufacturer, per-model or per-product number; nine categories are exempt from registration
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 devi…
Two authorisation forms for devices: state registration (IVDs) and entry on the medical device list (equipment and consumables)
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 registrat…
2 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
The accelerated foreign-approval route is statutory and applies to medicines and pharmaceutical substances only, not to medical devices
statement: Mongolia's accelerated foreign approval route is a medicines route and does not reach medical devices. Article 16.9 of the Law provides that medicines and pharmaceutical substanc…
The Agency may conclude cooperation MoUs with foreign counterpart bodies, but the power creates no device recognition route
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 mem…
6 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Registration and listing are filed by the manufacturer, a supplying organisation or the manufacturer's official representative
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 manufacture…
1 source-linked fact
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Import-supply permit condition: premises and staffing meeting the storage-and-distribution standard
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 huma…
Import-supply special permit is required to import and supply medical devices
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…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Twelve-item equipment listing dossier and ten-item consumables listing dossier
Entry of medical equipment on the medical device list requires twelve documents, including a copy of the ISO 13485 certificate, the product's marketing authorisation or free sales certifica…
Ten-item IVD registration dossier including ISO 13485, performance and stability data, clinical evaluation results and Mongolian-labelled IFU
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 di…
2 source-linked facts
Checked 2026-09-16
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D10

Official forms & portals

Verified
IVD registration applications are filed through the E-business electronic system
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 Agen…
Device-listing application is the applicant's official letter plus the manufacturer-signed original application
An application to enter medical equipment into the medical device list is made up of the applicant organisation's official letter and the original application for entry of the device into t…
2 source-linked facts
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
IVD and equipment instructions for use must be in Mongolian; the equipment user manual and device labels may be Mongolian or English
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 Mongolia…
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
State inspectors inspect device quality and safety and may inspect without a warrant on serious-risk findings
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…
Manufacturer's ISO 13485 certificate is the QMS evidence required for device listing
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…
2 source-linked facts
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
CRC type approval and conformity mark for information and communication equipment
Wireless / radio
Legal metrology: type approval, state-database registration and verification of measuring instruments
Metrology
Licence for radiation generators: possession, use, sale, transport, import and export
Radiation
5 maintained overlays
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D14

Fees

Verified
Special permit to manufacture and export medicines, medical equipment, laboratory diagnostic devices and medical supplies
MNT 44,000–110,000
Special permit to import and supply medicines, medical equipment, laboratory diagnostic devices and medical supplies
MNT 50,000–200,000
4 maintained fee lines
Checked 2026-09-16
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D15

Review clocks

Verified
Laboratory diagnostic devices (IVD) of medium and high risk (classes B, C, D) — state registration with a 5-year certificate · 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
55 working days
Medical equipment and medical consumables of medium and high risk (grades IIa, IIb, III) — entry on the medical device list · 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
30 working days
Amendment of an existing medical device list entry (manufacturer, labels, packaging or stability change) · 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
10 working days
4 maintained pathways · 1 related fact
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
IVD registration and certificate are valid for five years; renewal must be requested two months before expiry
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…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Amendments require a five-item dossier for IVDs; listed equipment and consumables are updated in the electronic database
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…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Manufacturers must enter the serial number, standard code and quantity of each device batch into the electronic database
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 regis…
1 source-linked fact
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical evaluation and study results are a mandatory IVD registration dossier item
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…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Nine categories of device are exempt from registration, including devices for disaster and public-health emergencies and for personal use
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…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
The supplying organisation must conduct surveillance on the devices it supplies, bear testing costs and recall non-conforming devices
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…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Health and supply organisations must record and promptly notify adverse effects and non-conformities
Health organisations and supply organisations must keep a continuous record of information on adverse effects and safety issues connected with the use of medical equipment and medical consu…
Current device vigilance, recall and rapid-alert procedure is Annex 1 to Order No. A/130 of 6 June 2025
The head of the Medicines and Medical Devices Control and Regulatory Agency approved, by Order No. A/130 of 6 June 2025, the 'Procedure on reporting, recalling, rapidly alerting on and dest…
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Recall deadlines of 24 hours, 72 hours or 14 days by severity; the supplying organisation bears the cost
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…
1 source-linked fact
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Device advertising must follow the statutory principles and requires a permit from the Agency
Medical device advertising and promotional activity must follow the common principles in Art. 26.1: it must be based on information and instructions for use confirmed by the State administr…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Appeal against a device decision runs through the general administrative-law complaint route
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 co…
Removal decisions may be reconsidered by the Medical Device Council within one month
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 deci…
2 source-linked facts
Checked 2026-09-16
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Government fees

Full fee schedule (4 lines) →

Ministry of Health / Medical Device and Medical Equipment Regulatory Agency (MMRA); State Stamp Duty administered under the Law on State Stamp Duty registration fees in MNT · reviewed 2026-09-16

Fee lineAmountProvenance
Special permit to manufacture and export medicines, medical equipment, laboratory diagnostic devices and medical suppliesMNT 44,000–110,000Verified
Special permit to import and supply medicines, medical equipment, laboratory diagnostic devices and medical suppliesMNT 50,000–200,000Verified
Special permit to sell medicines and medical devicesMNT 44,000–110,000Verified
State stamp duty — combined manufacture, sale and import permit for medicines, medical devices, instruments, equipment, prostheses and orthopaedicsMNT 110,000Verified

Registration timeline

Full registration timeline →

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 (Medicines and Medical Devices Regulatory Agency (MMRA)) review clocks and planning ranges · 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 classification

Class / pathwayReview clockPlanning totalProvenance
Laboratory diagnostic devices (IVD) of medium and high risk (classes B, C, D) — state registration with a 5-year certificate(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)55 working days3-6 monthsVerified
Medical equipment and medical consumables of medium and high risk (grades IIa, IIb, III) — entry on the medical device list(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)30 working days4-8 monthsVerified
Amendment of an existing medical device list entry (manufacturer, labels, packaging or stability change)(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)10 working days1-3 monthsVerified
Low-risk devices (grade I equipment and consumables, class A IVDs) — no registration and no list entry under Art. 33.9.1(Statutory exemption under Art. 33.9; an import declaration per consignment still applies to the Art. 33.9.1 to 33.9.8 categories)0 daysImmediateVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(55 working days)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 4 Mongolia regulations →

Official Medicines and Medical Devices Regulatory Agency (MMRA) rules and guidance · 4 of 4 documents linked to official sources

Засгийн газрын 2020 оны 222 дугаар тогтоол (Government Resolution No. 222 of 16 December 2020)Establishment of the Agency for the Control and Regulation of Medicines and Medical Devices
GeneralVerified
Эм, эмнэлгийн хэрэгслийн тухай хууль /Шинэчилсэн найруулга/ (Law of 5 June 2024, revised edition)Law on Medicines and Medical Devices (revised edition)
GeneralVerified
А/130 дугаар тушаал (Order A/130 of 6 June 2025)Procedure for Reporting, Recalling, Rapid Alerting and Destroying Medicines, Medical Devices and Health Supplements
VigilanceVerified
Эрүүл мэндийн сайдын А/206 дугаар тушаал (Order A/206 of the Minister of Health)Procedure for Registering Medicines, Medical Devices, Pharmaceutical Substances and Health Supplements
RegistrationVerified
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