The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules prescribing the collection of samples to be conducted by the NDDA in the course of continuous monitoring of the quality of medicines and medical devices marketed in the country.
In accordance with the notice published on the official website, the NDDA specialist would collect the samples of medicinal products on an annual basis. For this purpose, the National Center would form a plan of sample collection and communicate it to the medical device manufacturers or their authorized representatives. The plan would be subject to review on a quarterly basis depending on the newly registered medical devices, or the absence of the ones already included in the plan.
The scope of medical devices subject to mandatory sample collection includes the following ones:
- Sterile medical devices,
- Medical devices that constitute personal protective equipment intended to protect the patients or healthcare professionals and used for medical purposes for individual protection, except implantable ones, in vitro diagnostic devices, and medical equipment.
The collection of samples described herein should be performed in organizations engaged in manufacturing, distribution (both retail and wholesale) of medical devices, and also in healthcare organizations. In the course of such collection, the appropriate action should be concluded.
The number of medical devices to be collected should be sufficient for a single laboratory examination. Moreover, the same quantity of control samples should be collected. The sample collection methods used should ensure that medical devices collected for examination are intact and represent the medical devices available on the market. The medical devices collected as samples should be protected from any impact or damage in order to ensure the accuracy and reliability of the results of the future examination.
The NDDA also mentions that a similar sample collection procedure has been already applied earlier in 2019 and 2020 when the number of medicines and medical devices collected for examination reached 592 and 895 pieces respectively.
New Sample Collection Rules in Detail
According to the official notice, the new sample collection rules have been introduced by the appropriate order of the acting as the Minister of Healthcare of the Republic of Kazakhstan dated December 24, 2020, and registered by the country’s Ministry of Justice on December 26, 2020. The regulatory approach prescribed by the new rules is based on the Code of the Republic of Kazakhstan “On public health and healthcare system”. The new rules take effect in 10 calendar days from the date of their first official publication.
First of all, it is important to mention that the procedure of drafting a sample collection plan includes the coordination and agreement with the medical device manufacturer. In accordance with the procedure prescribed by the new rules, the plan should be formed before December 10 of each year. Then the NDDA shall communicate the plan to the medical device manufacturers and their authorized representatives for further negotiation. Should the manufacturer or its authorized representative fail to submit a response within 30 calendar days from the day the request was communicated by the NDDA, the latter would, within 10 calendar days, send the appropriate notice to the state regulating authorities for taking measures.
As it was mentioned before, the scope of organizations the NDDA may collect the samples from includes, inter alia, the retailers and wholesalers, such as pharmacies, warehouses, medical device stores, as well as healthcare organizations, providing that the representative of the medical device manufacturer is present.
Sample Collection Procedure
The new rules also prescribe a multi-step sample collection procedure. According to the rules, each step includes the collection of samples in a random way proportionally to the number of samples collected on the previous step, while the number of steps should be based on the type of packaging.
- First step – a selection of packaging pieces (boxes),
- Second step – a selection of particular packages contained in packaging pieces,
- Third step – a selection of the particular products contained in the individual packaging.
The collected samples should be separated from other products and labeled on the place of collection. Later they should be sent for control in the packaging prescribed by the manufacturer and applicable regulations. Prior to the collection of samples, the NDDA specialists shall assess the quality, integrity of the packaging, as well as its compliance with the applicable regulations. The temperature conditions (temperature and conditions) should be checked simultaneously. As was already mentioned before, it is important to ensure the collection methods do not impact the quality and characteristics of medical devices.
The criteria to be considered when collecting the samples should include the following ones:
- Homogeneity of the batch,
- Representativity of the selection with regard to composition,
- Representativity of the selection with regard to quality,
- Compliance of the samples collected with the identifiable features.
The samples collected should be the same as the medical devices intended for marketing in terms of design, composition, and manufacturing technology. The selection of samples with regard to the composition should reflect the full scope of the products subject to review, including the types, models, and sizes. In case of medical devices of various sizes, or ones included in the set, the selection should contain the samples from different batches to be distributed for examination with regard to different quality metrics in accordance with the applicable regulations establishing the requirements on the quality of medical devices.
The new rules also include a template of the sample collection act. As it was already mentioned before, such an act should be signed by both representatives of the NDDA and medical device manufacturers. According to the template, the act shall contain the following information:
- Name of organization,
- Place where the collection takes place,
- Details of the NDDA specialist who conducted the sample collection,
- Name of the representative of the medical device manufacturer,
- Reference to the regulations to be applied when conducting the examination of samples,
- Number of the declaration,
- Details of the medical device manufacturer, including the name, address, and country of origin,
- Details of the supplier, including the name, address, and country,
- Findings of the inspection,
- Details on storage conditions,
- Description of the packaging,
- Labeling details,
- List of medical devices collected.
Summarizing the information provided here above, the new rules describe the procedures to be applied when collecting the samples of medical devices and other medicinal products in the course of the annual quality assessment and examination to be conducted by the NDDA. In particular, the new rules outline the key criteria and points to be considered, as well as the documents to be drafted. The rules provide the approach to be applied when determining the number of samples of medical devices to be collected and the way the representativity should be ensured.
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