Kazakhstan - Top Medical Device Alerts

Sampling plan for assessing the quality of medicines and medical devices in circulation in the Republic of Kazakhstan for 2023. Manufacturers (registration certificate holders of medicines, authorized representatives of the manufacturer of medical devices), based on the Rules for selection from the market, including medical organizations, medicines and medical devices subject to quality control taking into account the risk-based approach, registered in the Republic of Kazakhstan, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 24, 2020, No. ҚР ДСМ-323/2020, we place a sampling plan for assessing the quality of medicines and medical devices in circulation in the territory of the Republic of Kazakhstan for 2023.

Changes have been made to the rules for assessing the quality of medicines and medical devices registered in Kazakhstan. The Minister of Health of the Republic of Kazakhstan, dated September 14, 2022, No. KR DSM-99 amended the rules for assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan.

Kazakhstan Announces Inspections Prior to Registration. According to the notice published by the country's regulating authority, medical devices should be subject to an inspection before registration.

Kazakhstan Announced Updated Manufacturing Rules. The NDDA has published an official announcement on Kazakhstan's updated rules on manufacturing medicines and medical devices.

New Labeling Requirements The NDDA has announced new rules for labeling medicines and medical devices. The new rules prescribe the scope of information to be included in the labeling and how it should be provided.