Mongolia medical device regulations

Монгол Улсын Засгийн газрын 2020 оны 222 дугаар тогтоол, adopted under Art. 183.1 of the Law on the Government, Art. 4.4 of the Law on Medicines and Medical Devices and Arts. 5.1 and 9.1 of the Law on the Legal Status of a Government Agency. Six operative clauses: it establishes the Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар as the implementing agency in the Minister of Health's portfolio (clause 1), fixes its staff ceiling at 132 (clause 2), approves its structure and programme and sets 1 January 2021 as the start of operations (clause 3), transfers functions from the Ministry of Health, the Professional Inspection Centre and local bodies (clause 4), funds it from the approved budget (clause 5) and repeals the earlier agency arrangements (clause 6). The legalinfo.mn expression carries two inline notes recording amendment by Government Resolution No. 378 of 2021, and the annexed table row (ordinal 32) is reproduced inside clause 6 as the source prints it. Issued by the Government; the agency it creates is the body that later issued Order A/130 of 2025.

Эм, эмнэлгийн хэрэгсэл, эмийн тухай хууль, revised edition adopted at the State Palace, Ulaanbaatar on 5 June 2024 and in force from 1 October 2024 (Art. 61.1). Chapters 1–10 and Articles 1–61. The device regime sits in Chapter 4 (medical-device control and regulation), with Chapter 2 governing the special licences an operator must hold, Chapter 3 the medicines regime, Chapter 5 health supplements, Chapter 6 import and export, Chapter 7 procurement and price control, Chapter 8 the role of state bodies and non-state organisations, and Chapter 9 inspection. Art. 4.1.10 defines the medical device and its sub-terms (laboratory/IVD device, medical equipment, medical consumables). Adopted by the State Great Khural; the Ministry of Health is the administrative body the law charges with the register. The retrieved legalinfo.mn expression carries the legal database's own inline amendment notes to individual articles, including the law of 3 July 2026, and is ingested as the consolidated text the database serves.

Эм, эмнэлгийн хяналт, зохицуулалтын газрын даргын 2025 оны 6 дугаар сарын 06-ны өдрийн А/130 дугаар тушаал, adopted under Art. 7.1.1 of the Law on the Legal Status of a Government Agency, Art. 40.1 of the General Administrative Law and Art. 50.2 of the Law on Medicines and Medical Devices. Four operative clauses: it approves, as Annex 1, the procedure for reporting, recalling, rapidly alerting and destroying medicines, medical devices and health supplements (clause 1); binds the heads of health and supply organisations and the directors of representative offices (clause 2); assigns the work to the Drug Safety Surveillance and Research Division and oversight to the Administration Division (clause 3); and repeals Order A/237 of 15 December 2022 (clause 4). Issued by the chairman of the Эм, эмнэлгийн хяналт, зохицуулалтын газар — the agency created by Government Resolution No. 222 — and signed in the chairman's temporary absence; the vigilance instrument that complements the registration procedure in Order A/206.

Эрүүл мэндийн сайдын 2025 оны 5 дугаар сарын 26-ны өдрийн А/206 дугаар тушаал, signed with its five annexes. Annex 1 is the procedure for registering medicines, pharmaceutical substances and health supplements (SmPC and API documentation, conditional registration, certificates); Annex 2 is the procedure for registering medical devices, including the national register and the in vitro diagnostic route; Annex 3 is the procedure for registering health supplements; Annex 4 holds the ten application forms for the three procedures; Annex 5 holds the six certificate and letter templates. This is the instrument that defines medical-device registration in Mongolia. Issued by the Minister of Health; the registration authority it addresses is the Эм, эмнэлгийн хэрэгсэл, эрүүл мэндийн нэмэлт бүтээгдэхүүнийг бүртгэх газар. Ingested from the ministry's signed PDF. Its first two pages — the order body itself and the opening of Annex 1 — carry no text layer, so they are page images and are outside the citeable expression, which begins inside clause 2.5 of Annex 1; that is a property of the official file, not a gap in the ingest. The annex headers print the ministry's placeholders for the signature month, day and order number unrepaired, as the source does.