Kazakh regulatory authorities
The Ministry of Healthcare of the Republic of Kazakhstan (MH RK, hereinafter referred to as the “Kazakh Ministry of Health”) is the highest regulatory authority for medical devices in Kazakhstan, with primary responsibility for policy formulation, registration and approval, market access, and post-market surveillance of medical devices (MD) and pharmaceuticals. The Committee for Medical and Pharmaceutical Control (KMFK) is the core executive body directly under the Ministry of Healthcare of the Republic of Kazakhstan and serves as the actual approval authority for medical device registration and regulation.
Regulatory Authority Website: https://www.ndda.kz/
Regulatory Framework
Law of the Republic of Kazakhstan “On the Health of the People and Healthcare” (2010): Foundational legislation.
“Rules on the Circulation of Medical Devices” (2015): Detailed rules for registration and circulation.
EAEU TR 032/2017: Unified Technical Regulation on Medical Devices of the Eurasian Economic Union.
“Regulations on the Registration of Medical Devices”: Registration procedures and technical documentation requirements.
Risk Classification
According to Decree No. ҚР ДСМ-281/2020, the risk classification for medical devices and IVDs is as follows: Class 1, Class 2a, Class 2b, Class 3
Licensee Requirements
The licensee may be a domestic Kazakhstani company or an authorized representative for imported products;
The holder must possess relevant qualifications for medical device operations, be familiar with local regulations, and be responsible for post-market compliance management (e.g., adverse event reporting, product recalls, etc.).
Registration Languages
Russian and Kazakh
Registration Process, Timeline, and Official Fees
Preliminary Preparation: Determine the product’s risk class, appoint a Kazakhstani authorized representative, prepare technical documentation, and complete translation and certification;
Submission of Application: Submit registration materials;
Preliminary Review: The regulatory authority reviews the completeness of the documents; missing materials must be supplemented;
Technical Evaluation: Technical documentation is reviewed based on the risk class; high-risk products require additional laboratory testing or on-site GMP audits;
Certificate Issuance and Publication: Upon approval, a Medical Device Registration Certificate is issued and published in the official database.
