State registration of medical devices in the Republic of Kazakhstan.
The state registration system in the Republic of Kazakhstan is quite similar to the registration system in the Republic of Belarus. First of all, the procedure for the applicant’s interaction with regulatory authorities calls attention to itself. If in Russia, for example, it is difficult to contact expert centers responsible for examining the effectiveness and safety of MD, and all communication is carried out through Roszdravnadzor, then in Belarus and Kazakhstan in the framework of national procedures, communication with the expert centers is organized directly. However, the registration procedure in Kazakhstan also has its own features, which will be covered in this article.
In Kazakhstan, the expert center directly interacting with the applicant is the National Center for Expertise of Medicines and Medical Devices. The first “pre-registration” stage of the entry of a medical device into the market of Kazakhstan starts from the interaction with this institute:
- To conduct an examination, the applicant enters into an agreement with an expert organization and provides:
- Application and registration dossier;
- Confirmation of payment under the agreement;
- MD samples.
- Registration of the application and verification of the residual shelf life of MD samples — 1 wd
- Initial examination of MD — assessment of the dossier completeness (for MD of 1 and 2a risk classes — 10 calendar days (cd) for MD of 2b and 3 risk classes — 20 cd) +60 cd to eliminate the request.
- Specialized expertise of MD – expert assessment and analysis of registration dossier documents confirming the safety, quality and effectiveness of MD (for MD of 1 and 2a risk classes — 40 cd., for MD of 2b and 3 risk classes — 70 cd) + 60 cd to eliminate the request.
- Laboratory tests of MD are carried out upon successful completion of initial and specialized examination of MD (for MD of 1 and 2a risk classes — 30 cd, for MD of 2b and 3 risk classes — 60 cd):
- analysis of technical and regulatory documentation of the MD in terms of testing procedures;
- testing samples of a medical device (physico-chemical, biological and technical);
- determining the reproducibility of test procedures
- inspection of the production site (MD of 2a (sterile), 2b and 3 risk classes for manufacturers who have not previously registered products in the Republic of Kazakhstan or have not previously supplied products with production sites in the Republic of Kazakhstan — no more than 120 cd)
- Approval of final documents (instructions, package layouts) + preparation of conclusion — 30 cd
The report on the safety, quality and effectiveness of a medical device is valid for one hundred and eighty calendar days.
- Submission of an application, confirmation of payment of state duty and a copy of an opinion on the safety, quality and effectiveness of MD in electronic form to the Ministry of Health of the Republic of Kazakhstan
- Checking the completeness of the submitted documents, as well as their compliance with the requirements, preparation of a draft permit document.
- Issuance of an RC with unlimited validity period and publication of RC, instructions for medical use and package layouts on the e-government portal
The total period of service provision: 5 wd
Thus, the introduction of the EAEU procedure significantly changes the process of registering a medical device in Kazakhstan. Applicants, at a minimum, need to conduct a set of tests to prove the effectiveness and safety of the MD before carrying out the examination.
- Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-10.
- Order of the Minister of Health of the Republic of Kazakhstan dated February 9, 2021 No. KR DSM-16.
- Order of the Minister of Health of the Republic of Kazakhstan dated December 23, 2020 No. KR DSM-315/2020