Sampling of products collected from the market is carried out using a risk-based approach
We provide comprehensive support throughout the entire sampling process
Sampling of Market Products
According to Order No. ҚР ДСМ-323/2020, Chapter 1, Clause 4:
— “The expert organization shall, annually by November 1, develop and approve a sampling plan for the quality assessment of medicinal products and medical devices circulating in the territory of the Republic of Kazakhstan for the following calendar year (hereinafter referred to as the “plan”), and shall make it publicly available on the official website of the expert organization”.
— “The expert organization shall, annually by November 1, develop and approve a sampling plan for the quality assessment of medicinal products and medical devices circulating in the territory of the Republic of Kazakhstan for the following calendar year (hereinafter referred to as the “plan”), and shall make it publicly available on the official website of the expert organization”.
If the manufacturer fails to carry out the market sampling procedure, the expert organization shall forward the relevant information to the State Authority for decision-making in accordance with Clause 2, Article 259 of the Code “On the Health of the People and the Healthcare System”:
- suspension, prohibition, or withdrawal from circulation, or
- restriction on the use of medical devices.
Steps for Market Sampling
Agreement with the Expert Organization
Approval of Sampling Schedule and Location
Payment for Testing
Sampling by Experts
First Stage of the Procedure – Labeling Examination
Laboratory Testing
Procedure Outcome
The state expert organization issues a decision on the conformity/non-conformity of the products along with the test protocols
If the Result is Positive (Meets Requirements)
A notification of conformity of the sampled products with the established requirements is issued, along with a copy of the test protocol(s).
If the Product Does Not Conform
A notification of negative laboratory test results is issued, along with a copy of the test protocol(s), to allow for appropriate regulatory actions (revocation of the conformity certificate and removal of the product from the market, or amendments to the registration certificate).
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