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Mongolia medical device government fees

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Ministry of Health / Medical Device and Medical Equipment Regulatory Agency (MMRA); State Stamp Duty administered under the Law on State Stamp Duty current fee schedule, reviewed for 2026, in MNT.

4 fee lines100% exact amountscurrency MNTFX rates 2026-09-17reviewed 2026-09-16
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Special permit to manufacture and export medicines, medical equipment, laboratory diagnostic devices and medical supplies
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.
MNT 44,000–110,000$12.16–$30.40Per permit issuedVerified
Special permit to import and supply medicines, medical equipment, laboratory diagnostic devices and medical supplies
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.
MNT 50,000–200,000$13.82–$55.27Per permit issuedVerified
Special permit to sell medicines and medical devices
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.
MNT 44,000–110,000$12.16–$30.40Per permit issuedVerified
State stamp duty — combined manufacture, sale and import permit for medicines, medical devices, instruments, equipment, prostheses and orthopaedics
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.
MNT 110,000$30.40Per permit issuedVerified
Government fees only — service and testing costs are separate
  • 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.
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Exact amounts verified against the Ministry of Health / Medical Device and Medical Equipment Regulatory Agency (MMRA); State Stamp Duty administered under the Law on State Stamp Duty fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:mongolia:special-permit-manufacture-export