Registration Procedures for medicines, medical devices and health supplements and key provisions

Mongolia • No. 05/2025 • July 2025

In brief

In connection with the revised Law on Medicines and Medical Devices (“LMMD”) which came into effect on October 1, 2024, the following procedures were adopted on May 26, 2025, by the Order No. А/206 of the Minister of Health:

• Procedure for Registration of Medicines and Active Pharmaceutical Ingredients;

• Procedure for Registration of Medical Devices; and

• Procedure for Registration of Health Supplements.

These new procedures replace the previous 2019 Procedure for Registration of Medicines, Raw Materials, and Biologically Active Products (“Previous Procedure”), which is now repealed. Given the critical role these procedures play in the registration of medicines, medical devices, and health supplements, this newsletter summarizes the key changes and core regulatory provisions. These procedures are:

• Procedure for Registration of Medicines and Active Pharmaceutical Ingredients
• Procedure for Registration of Medical Devices
• Procedure for Registration of Health Supplements