Mongolia MMDRA Medical Device Registration: LICEMED and 2025 Procedure Guide

Quick answer

Mongolia requires state registration of medical devices before import, supply, or use in the human healthcare market. The Authority for Health and Medical Device Regulation (MMDRA) under the Ministry of Health (MOH) administers registration under the revised Law on Medicines and Medical Devices (2024), effective 1 October 2024, and Minister of Health Order No. A/206 dated 26 May 2025, which adopts Attachment 2 — Procedure for Registration of Medical Devices. Applications are filed through the LICEMED information system at http://licemed.mohs.mn/. The applicant must hold a valid import-supply license under the revised LMMD licensing framework. Foreign manufacturers may register only through a Mongolian LLC subsidiary that holds the import-supply license — representative offices cannot apply because they are not eligible for profit-making licenses. Order A/206 replaces the 2019 MOH Order A/295 registration procedure and unifies registration rules for medicines, medical devices, and health supplements. The WTO import-licensing notification for Mongolia confirms LICEMED as the official channel for human medicines and medical devices.

Who this applies to

This guide applies to:

• Foreign manufacturers exporting medical devices, IVD reagents, or implantable products to Mongolia
• Mongolian LLC subsidiaries of foreign manufacturers holding import-supply licenses
• Local importers and distributors placing registered devices on the Mongolian market
• Regulatory affairs teams mapping EU MDR, FDA 510(k)/De Novo, PMDA, or EAEU pathways to Mongolia's 2025 procedure
• Hospital procurement and tender teams verifying state registration before purchase

Scope covers human medicines and medical devices regulated under the revised LMMD — including medical instruments, equipment, accessories, and prostheses referenced in Mongolia's WTO permit notification. Veterinary devices and livestock animal medicine equipment follow separate MOH permit categories. If your product is used for diagnosis, prevention, monitoring, or treatment of human disease, assume MMDRA registration is required unless MOH publishes a specific exemption.

Regulatory framework: revised LMMD 2024 and Order A/206

Mongolia's medical device market access rests on two primary legal instruments:

The 2024 LMMD modernizes the 2010 law by:

• Consolidating activity licenses from five types to three: manufacturing-export, import-supply, and related combined permits
• Requiring the import-supply license holder to be the registrant for imported medicines and medical devices
• Clarifying that foreign manufacturers register through Mongolian LLC subsidiaries, not representative offices
• Strengthening MMDRA oversight of registration, licensing, and post-market control

Order A/206 repeals the 2019 MOH Order A/295 Procedure for Registration of Medicines, Raw Materials, and Biologically Active Products (partial attachments). Manufacturers with legacy registrations should confirm transition rules on legalinfo.mn and moh.gov.mn at the time of renewal or variation.

Regulator: MMDRA under Ministry of Health

The Authority for Health and Medical Device Regulation (MMDRA) operates under MOH as Mongolia's national regulator for human medicines and medical devices. MMDRA responsibilities include:

MMDRA contact information for special permits and regulatory inquiries is published on the MOH website at https://moh.gov.mn/p/140. For LICEMED system access and registration submissions, use the dedicated portal rather than informal email channels unless MOH publishes a specific contact for technical support.

LICEMED portal: http://licemed.mohs.mn/

LICEMED is Mongolia's official information system for registration and lifecycle management of human medicines and medical devices. The WTO import-licensing notification for Mongolia identifies LICEMED as the designated channel for these product categories, with system access at http://licemed.mohs.mn/.

LICEMED supports:

• Registration application submission under Order A/206 Attachment 2
• Dossier upload and version tracking
• Registration certificate issuance using the model registration certificate template adopted in Order A/206
• State register queries for registered products
• Renewal and variation workflows as defined in the 2025 procedures

Foreign manufacturers and their Mongolian LLC subsidiaries should establish LICEMED user accounts early. Incomplete portal profiles or missing import-supply license linkage are common causes of application rejection at intake. Verify the active portal URL on moh.gov.mn before filing — WTO and MOH publications reference licemed.mohs.mn as the current system endpoint.

Import-supply license prerequisite

Under the revised LMMD 2024, the entity that registers an imported medical device in the state register must hold a valid import-supply license. This license covers both import and supply operations — replacing the separate import and supply licenses under the 2010 law.

Key licensing rules:

Apply for the import-supply license before initiating device registration on LICEMED. Registration applications from entities without an active license are not accepted. Budget license application lead time separately from dossier preparation and MMDRA review.

Foreign manufacturer: Mongolian LLC, not representative office

The revised LMMD 2024 explicitly addresses foreign manufacturer market entry:

• Permitted route: Register medical devices through a Mongolian LLC subsidiary that obtains an import-supply license
• Prohibited route: Representative offices — legal entities established solely as representative offices cannot engage in profit-making activities and are not eligible to apply for import-supply licenses or register imported medical devices

Practical implications for foreign manufacturers:

1. Establish or appoint a Mongolian LLC — Either a wholly owned subsidiary or a joint venture with a local partner who holds or co-holds the import-supply license
2. Execute manufacturer–subsidiary authorization — Document the foreign manufacturer's appointment of the LLC as regulatory and commercial contact for Mongolia
3. Obtain import-supply license — LLC applies to MOH/MMDRA under LMMD licensing rules
4. Register devices on LICEMED — LLC submits Attachment 2 dossiers as license-holding registrant
5. Maintain local compliance — LLC remains responsible for post-market reporting, recalls, and renewal filings

Representative offices may support liaison or market development but cannot substitute for the LLC registration pathway. Regulatory affairs teams accustomed to authorized representative models in the EU or GCC should map Mongolia's LLC requirement explicitly in market-entry planning.

WTO reference: LICEMED and permit requirements

Mongolia's WTO import-licensing notification (reference lic-public.wto.org/en/legislations/3027) confirms:

The WTO notification aligns Mongolia's domestic registration system with its international trade commitments. Importers should treat LICEMED registration and import-supply license as dual prerequisites — customs clearance without both creates enforcement risk under LMMD and Permits Law.

Registration dossier under Attachment 2

Minister of Health Order A/206, Attachment 2 — Procedure for Registration of Medical Devices defines the registration application content, review steps, and certificate format. Order A/206 also adopts:

• Model registration application form — Standard template for LICEMED submission
• Model registration certificate — Official certificate format upon approval

Core dossier elements under Attachment 2 (align dossier to the published Mongolian text on legalinfo.mn):

MMDRA may request additional documents during expert review. Reference approvals from EU MDR, FDA, EAEU, or neighboring markets strengthen the dossier but do not replace Mongolia state registration under Attachment 2.

Registration certificate

Upon successful review, MMDRA issues a registration certificate using the model registration certificate template adopted in Order A/206. The certificate confirms:

• Registered trade name and device identifiers
• Manufacturer name and country of origin
• Mongolian LLC registrant (import-supply license holder)
• Registration number and issue date
• Validity period and renewal conditions per Attachment 2

Registered devices are published on the state register accessible through LICEMED. Importers, distributors, and hospital procurement teams should verify register status before purchase or shipment. A foreign CE certificate or FDA clearance alone does not authorize supply in Mongolia without MMDRA registration.

Plan renewal per Attachment 2 timelines before certificate expiry. Lapsed registration blocks lawful import and supply under the revised LMMD 2024.

Step-by-step registration workflow

Step 1 — Confirm device scope under revised LMMD 2024
Step 2 — Establish Mongolian LLC (foreign manufacturers)
Step 3 — Obtain import-supply license for LLC
Step 4 — Create LICEMED account and link license
Step 5 — Assemble Attachment 2 dossier with model application form
Step 6 — Submit registration application on LICEMED
Step 7 — MMDRA expert review (respond to queries within published deadlines)
Step 8 — Registration decision and certificate issuance
Step 9 — Device published on state register via LICEMED
Step 10 — Plan renewal and post-market obligations

Detailed workflow:

1. Confirm device scope — Verify product is a registrable medical device under LMMD 2024; determine classification per Attachment 2.
2. Establish Mongolian LLC — Foreign manufacturers create or partner with an LLC; representative offices cannot register.
3. Obtain import-supply license — LLC applies to MOH/MMDRA; license must be active before registration filing.
4. Set up LICEMED access — Register users, link import-supply license, and confirm portal functionality at http://licemed.mohs.mn/.
5. Prepare dossier — Complete model application form; compile technical file, QMS certificate, FSC, IFU, labeling, and reference approvals.
6. Submit on LICEMED — Upload dossier through Attachment 2 workflow; retain submission reference.
7. MMDRA review — Expert evaluation; respond promptly to deficiency letters.
8. Receive certificate — Model registration certificate issued; confirm state register entry.
9. Import and supply — Align customs documentation with registration number and import-supply license.
10. Maintain compliance — Track renewal dates, variations, and post-market reporting obligations.

Registration checklist

Common pitfalls

1. Using a representative office instead of LLC — Representative offices cannot hold import-supply licenses or register devices; only Mongolian LLC subsidiaries qualify.
2. Filing before import-supply license issuance — Attachment 2 requires the license-holding registrant; premature LICEMED submission is rejected.
3. Ignoring Order A/206 transition — The 2019 Order A/295 procedure is repealed; renewals and new applications must follow Attachment 2.
4. Skipping LICEMED — WTO and MOH designate LICEMED as the official channel; paper-only or informal submissions are not valid pathways.
5. Relying on foreign approval alone — EU CE or FDA clearance supports the dossier but does not replace Mongolia state registration.
6. License–registrant mismatch — The LLC on the import-supply license must match the LICEMED applicant; corporate restructuring requires license update first.
7. Expired QMS or FSC at review — MMDRA checks certificate validity; stale documents trigger query cycles.
8. Late renewal — Lapsed registration blocks lawful import and supply; calendar renewal before expiry.

FAQ

Who regulates medical device registration in Mongolia?

The Authority for Health and Medical Device Regulation (MMDRA) under the Ministry of Health regulates registration of human medical devices. MMDRA administers the process under the revised Law on Medicines and Medical Devices (2024) and Minister of Health Order No. A/206 (26 May 2025), Attachment 2.

What is the revised LMMD 2024?

The revised Law on Medicines and Medical Devices was passed by Parliament on 5 June 2024 and became effective 1 October 2024. It replaces the 2010 law and modernizes licensing (including import-supply licenses), registration requirements, and MMDRA authority for human medicines and medical devices.

What is Minister of Health Order A/206?

Order A/206 dated 26 May 2025 adopts unified registration procedures for medicines, medical devices, and health supplements. Attachment 2 is the Procedure for Registration of Medical Devices, which replaces the 2019 Order A/295 registration procedure. Order A/206 includes model application and certificate templates.

What is LICEMED and how do I access it?

LICEMED is Mongolia's official information system for human medicines and medical device registration. Access it at http://licemed.mohs.mn/. The WTO import-licensing notification confirms LICEMED as the designated regulatory channel for these product categories.

Do I need an import-supply license before registering a device?

Yes. Under the revised LMMD 2024, the entity registering an imported medical device must hold a valid import-supply license. Apply for the license before submitting a registration application on LICEMED.

Can a foreign manufacturer register directly or through a representative office?

No. Foreign manufacturers must register through a Mongolian LLC subsidiary that holds an import-supply license. Representative offices cannot apply for licenses or register imported medical devices because they are not eligible for profit-making activities under Mongolian law.

Does EU CE marking or FDA approval replace Mongolia registration?

No. Reference market approvals from EU MDR, FDA, or other jurisdictions support your Attachment 2 dossier but do not replace MMDRA state registration through LICEMED. You must obtain a Mongolia registration certificate before lawful import and supply.

Where can I find the official legal texts?

Published texts are available on legalinfo.mn: the revised LMMD 2024 (lawId=17140713569541) and Order A/206 with Attachment 2 (lawId=17431727585102). MOH guidance and special permits are on moh.gov.mn, including https://moh.gov.mn/p/140.

Official sources

• Revised Law on Medicines and Medical Devices (2024): https://legalinfo.mn/mn/detail?lawId=17140713569541
• Minister of Health Order A/206 (26 May 2025) — Procedure for Registration of Medical Devices (Attachment 2): https://legalinfo.mn/mn/detail?lawId=17431727585102
• LICEMED registration portal: http://licemed.mohs.mn/
• MOH special permits — MMDRA contact: https://moh.gov.mn/p/140
• WTO import-licensing notification — LICEMED reference: https://lic-public.wto.org/en/legislations/3027