Assessment of the quality of medicines and medical devices
In order to sell medicines and medical devices in the territory of Kazakhstan, in addition to the registration of medicines and medical devices, the quality assessment of medicines and medical devices is a mandatory procedure.
Quality assessment is carried out in order to prevent the sale of low-quality, potentially dangerous and counterfeit products in the country that may harm consumers.
The quality assessment of medicines and medical devices registered in the Republic of Kazakhstan is carried out by determining the compliance of the quality of medicines and medical devices with the data of the registration dossier, regulatory documents on the quality of medicines, on the basis of which they were registered in the Republic of Kazakhstan and is carried out in accordance with the requirements of the Rules for conducting quality assessment of medicines and medical devices registered in the Republic of Kazakhstan, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 No. ҚР ДСМ-282/2020.
The assessment of the quality and safety of medical devices in Kazakhstan and the EAEU (Eurasian Economic Union) is carried out with the aim of:
- determining the quality of registered products
- determining the quality of products selected from the market taking into account the risk-oriented approach
- preventing the circulation of counterfeit products on the market of the Republic of Kazakhstan.
How certification and assessment of the quality and safety of medical devices are carried out in the Republic of Kazakhstan and the EAEU: Russia, Belarus, Kyrgyzstan and Armenia
Product quality assessment includes examination of documents when declaring products and laboratory testing of product samples selected from the market taking into account the risk-oriented approach during the validity period of the product conformity certificate.
Quality assessment is carried out for each series (batch) of products manufactured and imported to the Republic of Kazakhstan during the validity period of the registration certificate, including those registered in accordance with the Rules for the Registration and Expertise of Medicines for Medical Use, approved by the decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78 and the Rules for the Registration and Expertise of the Safety, Quality and Efficiency of Medical Devices, approved by the decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46.
The expert organization, within five working days from the date of receipt of the application, checks the submitted documents and verifies the data specified in them with the information provided in the State Register of Medicines and Medical Devices.
When organizing and conducting sanitary and anti-epidemic and sanitary and preventive measures and related restrictive measures, including quarantine, product quality assessment is carried out using an accelerated procedure within a period of no more than three working days from the date of receipt of the application.
In the event of an incomplete package of documents stipulated by paragraphs 7, 8 of the Rules, or provision of inaccurate information, the expert organization sends the applicant a notification via the information system about the elimination of the relevant comments. The applicant, within a period of no more than five working days from the date of receipt of the notification, which is not included in the general period for conducting the quality assessment of medicines and medical devices, eliminates the relevant comments.
Based on the results of the examination of documents, in the absence of comments, the expert organization draws up and registers in the information system of the expert organization a certificate of conformity for the product in the form according to Appendix 2 to the Rules.
When specifying a specific product covered by the certificate of conformity for the product, an appendix to the certificate of conformity for the product is additionally drawn up in the form according to Appendix 3 to these Rules.
The certificate of conformity for the product is issued in electronic format via the information system of the expert organization.
Validity of certification and quality assessment of medical devices in the Republic of Kazakhstan and the EAEU
The validity period of the product conformity certificate is set until the end of the shelf life (operation period) of the product, while the shelf life (operation period) is determined until the last day of the specified month (for medical equipment in accordance with the technical passport) inclusive.
Cost and prices for certification services and quality assessment of medical devices in the Russian Federation, the Republic of Belarus and the Republic of Kazakhstan – the EAEU countries
If you need to conduct a quality assessment of medicines or medical devices, our team will be happy to help you collect the necessary package of documents and submit an application.
To date, the Blitz Medica team has conducted more than 69 production assessments. Our specialists will consult you and help you obtain a certificate of conformity for your products.
