Mongolia medical device registration timeline

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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 end-to-end planning ranges, using the 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 system.

4 pathways4 of 4 clocks verifiedvalidity 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)MDSAP not acceptedreviewed 2026-09-16legalinfo.mn

Class / pathway	Review clock	Planning total	With prior approval	Provenance
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) 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.	55 working days	3-6 months	—	Verified
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) 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.	30 working days	4-8 months	—	Verified
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) 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).	10 working days	1-3 months	—	Verified
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) 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.	0 days	Immediate	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Mongolia Medical Device Registration Process

Step-by-step Medicines and Medical Devices Regulatory Agency (MMRA) registration process. Total estimated timeline: 3-6 months.

Step 1: Pre-Submission Preparation

1-3 months

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).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to Medicines and Medical Devices Regulatory Agency (MMRA) including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

Medicines and Medical Devices Regulatory Agency (MMRA) reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

55 working days

In-depth technical assessment of device safety and performance. Medicines and Medical Devices Regulatory Agency (MMRA) may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, Medicines and Medical Devices Regulatory Agency (MMRA) issues Mongolia market authorization certificate.

Summary: The Mongolia medical device registration process through 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)) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

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

WHO prequalification or the WHO list (medicines route only)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.

Institutional memoranda of understanding with foreign bodiesArt. 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.

Primary regulator sources

legalinfo.mn · 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 legalinfo.mn · 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)

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against Medicines and Medical Devices Regulatory Agency (MMRA) publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:mongolia:ivd-state-registration