The National Center for Expertise of Medicines and Medical Devices (NDDA), a Kazakhstan`s body responsible for the premarket assessment of medical devices, has published an official announcement about the implementation of the new importation and exportation rules for medical devices.
The new rules have been introduced by the appropriate order of the Minister of Healthcare of the Republic of Kazakhstan dated December 8, 2020 “On approval of the Rules of importation into the territory of the Republic of Kazakhstan and exporting outside of the territory of the Republic of Kazakhstan of medicines and medical devices, and for provision of state service “Issuing the approval and/or permission on importation (exportation) of medicines and medical devices registered and non-registered in the Republic of Kazakhstan.” The new rules become effective from the date of first publication, while all existing regulations are no longer valid.
The new importation and exportation rules are developed on the basis of the Code of the Republic of Kazakhstan “On health of the people and healthcare system” and describe the procedures to be followed by the interested party applying for special permission of importation or exportation of medicines and medical devices. It is also important to mention that the scope of the rules covers both medical devices duly registered in the Republic of Kazakhstan, and ones that have not been registered.
The new rules provide the definitions of the most important terms used in the context of importation and exportation, including the following ones:
- Standard of state services – the list of the main requirements for the provision of state services, including the characteristics of the process, form, content, and the result of the provision, as well as other services with regard to the specifics of the provision of state services;
- Good Manufacturing Practice (GMD) – standard in the sphere of healthcare, establishing the requirements for the organization of manufacturing process and provision of control in the course of manufacturing medicines and medical devices;
- Registration dossier – a set of documents and materials of the appropriate content to be submitted together with the application for the state registration, re-registration of medicine, medical device, or changes to the registration dossier.
Kazakhstan`s New Medical Devices Importation Rules
The first section of the new order is dedicated to the rules on the importation of medical devices into the Republic of Kazakhstan and the procedure of applying for the appropriate permission with regard to both registered and non-registered medicines and medical devices.
According to the new rules, in order to obtain permission for the importation of medicines and medical devices, the interested party shall submit the appropriate application accompanied with the set of documents prescribed by the present rules in electronic form via the “e-governance” portal.
The general timeline for the review of the application for importation permission constitutes three business days. In particular, the authorized officer of the regulating authority would check the completeness of the documents submitted within two business days from the date of submission. Should the set of documents submitted by the applicant be found incomplete, the regulating authority would issue a motivated refusal. The applicant may remedy the reason for refusal and apply for the second time. Upon submission of a complete set of documents, the applicant would receive the appropriate permission (approval) in electronic form (signed with the e-signature). The regulating authority is also responsible for entering all information to the appropriate informational monitoring system.
The whole procedure is fully automated and could be performed in electronic form. It is also important to mention that there is no fee payable for applying for the importation permission.
The medical devices already registered in the Republic of Kazakhstan could be imported without applying for additional permission (approval) of the regulating authority. All non-registered medical devices should be imported only providing they would be used by the particular healthcare institution applying for permission, or distributed within the particular region.
Actually, the new rules implement two separate frameworks to be applied depending on the purpose of importation of medical devices.
The first framework should be applied in case of importation of non-registered medical devices for the following purposes:
- Provision of medical care to the particular patient or a group of patients with the rare or especially severe disease;
- Prevention and/or prevention of consequences of emergency;
- Provision of humanitarian aid in cases, prescribed by the applicable regulations;
- Implementation of innovative medical technologies;
- Purchase of medical devices supplied by international organizations.
The second framework should be applied in the case of importation of non-registered medical devices for the following purposes:
- Importation of samples of medical devices for the purpose of state registration, re-registration, or changes to registration dossier;
- Participation in medical exhibitions without the right of further marketing;
- Use as components to the medical devices that are not intended to be used as separate medical devices;
- Conducting clinical trials.
The general application for importation permission (approval) shall contain the following information:
- The name of the applicant, its business address, phone number, and email address;
- Tax identification number of the applicant;
- Name of the supplier;
- The country of importation and the country of exportation;
- Business address, phone number, and email address of the supplier;
- Country of the supplier;
- Receiving a healthcare institution, its business address, phone number, and email address;
- Number and date of the agreement;
- Number and date of specification (invoice);
- Number and date of issue of the license on pharmaceutical/medicinal activity;
- Customs authority through which the importation would take place;
- The currency of payment;
- Names of medical devices, batch numbers, amount of devices to be imported, name of the manufacture, and the country of origin.
Depending on the particular purpose of importation and the applicable framework, the set of documents to be submitted may contain the following ones:
- Statement from the local authorities regarding the purpose of importation;
- An electronic copy of the agreement together with the invoices, translated in Kazakh or Russian.
Exportation Rules for Medical Devices
The new rules also set forth the procedures to be followed when applying for permission for the exportation of medical devices. The same as in the case of importation permission, the application should be submitted in electronic form via the official online portal. The timeline is the same – three business days. Upon submission, the applicant would see the current status of the application in the personal cabinet. The application form to be submitted by the interested party applying for the exportation permission should contain the same information as in the case of importation approval. The set of documents to be submitted shall include the information about the applicant entity and the establishment license it holds.
In accordance with the general procedure, the regulating authority would review the completeness of the submission and notify the applicant of the decision taken. Should the set of documents be found incomplete, the applicant would be informed accordingly and will have time to remedy the noncompliances identified.
Summarizing the information provided hereabove, the new rules describe in detail the procedures to be followed when applying for importation or exportation permission. In particular, the rules prescribe the documents to be submitted, the applicable timelines, and other requirements associated thereto. The rules also set the reasons for refusal and actions to be taken by the applicant to regain compliance.
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