The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s agency responsible for the assessment of quality and safety of medical devices, has published an official notice describing the updated rules on a temporary suspension of distribution, withdrawals, and recalls of medicines and medical devices. This new version of the rules has been implemented in December 2020. The new rules have already entered into force and replaced the previous ones.
General Rules on Recalls and Withdrawals of Medical Devices
The updated rules prescribe the procedures to be fulfilled in case of temporary suspension of distribution, recalls and withdrawals, or limitations of the use of medicines and medical devices. The rules are based on the Code of the Republic of Kazakhstan “On public health and healthcare system” dated June 7, 2020.
The rules outline the definitions of the most important terms used in the context of recalls and withdrawals. For instance, the state expert organization in the sphere of circulation of medicines and medical devices (actually, it is the NDDA) – the state monopoly entity, conducting its activity in the healthcare sphere by ensuring the safety, effectiveness, and quality of medicines and medical devices.
The state regulating authority in the healthcare sphere is entitled to make a decision on suspension or prohibition of use, distribution, or manufacturing of medicines and medical devices, as well as on their recalls and withdrawals in the following cases:
- Non-compliance with the requirements set forth by the applicable legislation;
- Identification of adverse effects causing hazards to human health, that is not indicated in the instructions for use, or increase of the frequency of severe adverse effects, indicated in the instructions for use, or low effectiveness, or in case of information stating that the product has been subject to withdrawals and recalls on other markets due to unfavorable benefit-risk ratio;
- Identification of defects in construction, the principal mode of action, manufacturing processes, impacting the safety of use of a medical device for its intended purpose;
- Deviations from the approved manufacturing process impacting the safety, quality, and effectiveness of medical devices;
- Presence of the information about harm caused by a medical device to the patient’s or customer’s health;
- Receipt of the data on insufficiency of the scientific-technological level of manufacturing technologies and quality control, resulting in a decline of the medical device’s use safety level;
- Request, submitted by the license holder, to suspend, revoke of the registration certificate (license) or withdrawal or limitation of use of a medical device;
- Failure of the license holder or the medical device manufacturer to fulfill its obligations with regard to the monitoring of the safety, quality, and effectiveness of medical devices.
Withdrawal and Recall Procedure
Should the circumstances outlined hereinabove are present or identified, the regulating authority would, within one business day, notify the local regulating agencies, as well as the license holder. In case of adverse events or non-compliances, the expert organization would, within four calendar days from the date the information has been received, provide the calculations of the number of medical devices necessary for the laboratory examination. The samples necessary for such an examination should be collected by the local authorities within five calendar days. The samples of medical devices should be collected in the amount sufficient for a single laboratory examination. It is also important to mention that the value of the medical devices used for an examination would not be reimbursed. The collection of samples would be also confirmed by the appropriate action to be executed in accordance with the template also contained in the new version of the rules. The medical devices, samples of which were collected for examination, should be stored separately with the appropriate indications: “Seized until laboratory examination results would be received, not for sale.”
The officials of the local authorities shall deliver collected samples to the expert organization (NDDA) for laboratory examinations. The scope of laboratory examination should cover all applicable requirements set forth by the current legislation with regard to the quality of medical devices, excluding the indications requiring specific materials: equipment, reagents, standard samples, and conditions of examination, that are absent in the expert organization. Once finished, the laboratory forms a protocol of examination in accordance with the template also contained in the new rules and submits such a protocol to the regulating authorities within one business day.
The expenses associated with the laboratory examination of medical devices should be incurred by the medical device manufacturer, the license holder, or the authorized representative of the medical device manufacturers in accordance with the prices set forth by the applicable regulations.
In case if the results of the examination are positive, or the party responsible for a medical device manages to take necessary actions to restore compliance with the applicable requirements within the terms specified in examination acts, the regulating authority informs the local authorities on the decision taken within five calendar days. The latter shall notify the healthcare authorities on cancellation of marketing prohibition, withdrawal, or recall of medical devices. The appropriate information should be also published in mass media to ensure it was duly communicated to the stakeholders.
In case of negative examination results, or if the party responsible for a medical device fails to make requested changes within the appropriate term, the regulating authority takes a decision on prohibition of use, distribution, or manufacturing of medical devices and their withdrawal from the market. Should such a decision be made, the party responsible for a medical device in question shall, within five business days, to:
- Provide the local authorities with the information about the number of medical devices imported to the territory of the Republic of Kazakhstan, already distributed, and the ones remaining stored;
- Notifies all entities involved in operations with such medical devices on the necessity to return medical devices.
An entity holding the medical devices subject to withdrawal shall, within five days from the date the appropriate notice has been received, notify the regulating authority about the successful return of medical devices subject to recall to the manufacturer or distributor, accompanied with the appropriate certifying document. Later the local authorities shall provide the combined information on recall to the state regulating authority in the sphere of medical devices.
Document Samples
As was already mentioned before, the new rules on withdrawals and recalls of medical devices also contain the templates of the most important documents to be executed in the course of the aforementioned procedures. These templates are intended to be used by the parties involved in recalls and medical devices to ensure that all important information was duly recorded. For instance, the act of collection of samples of medicines and(or) medical devices shall contain the information about the place and date of such collection, the details of the parties` representatives participating in the procedure, and also on the medical devices collected.
Summarizing the information provided here above, the updated rules provide the detailed requirements with regard to the procedures and processes to be performed in case of withdrawals and recalls of medical devices. In particular, the rules specify the criteria to be applied when considering the actions to be taken to ensure the continuous safety and effectiveness of medical devices marketed in the Republic of Kazakhstan.
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