Authorized Representative of the Manufacturer
We handle interactions with regulatory authorities, ensure compliance with legislation, and officially represent the interests of the manufacturer
Authorized Representative of the Manufacturer
— a legal entity or individual entrepreneur registered as a resident of the Republic of Kazakhstan, authorized by the manufacturer’s power of attorney to represent the manufacturer’s interests regarding the circulation of medical devices within the territory of the Republic of Kazakhstan in accordance with the national healthcare legislation.
What Does the Authorized Representative Service Include?
24/7 Communication
Organization and maintenance of round-the-clock (24/7) communication, handling official correspondence, and designation of a responsible AR contact person.
Adverse Event Reporting
Preparation and timely submission of reports on all incidents to the local regulator, as well as submission of other mandatory notifications within deadlines established by medical device regulations.
Market Participant Notifications
Informing other market participants (distributors, manufacturer, etc.) about adverse events related to the medical device, the need or absence of corrective actions (including device recalls), and coordination of these procedures.
Notification of the Local Regulator on Significant Changes
Providing notifications if required by medical device regulations, upon receipt of relevant information from the client.
Handling and Responding to Requests from Authorities and Third Parties
Receiving, reviewing, and responding to inquiries from regulatory authorities, legal entities, and individuals regarding the devices, after prior consultation and agreement with the client.
Handling Consumer Requests
Receiving, reviewing, and responding to consumer inquiries about devices, informing about identified risks if necessary in accordance with medical device regulations, after prior consultation with the client.
Responses to Regulatory Requests
Providing information and documents on conformity assessment related to device safety to the local regulator and other competent authorities upon request, after prior consultation with the client.
Document Storage
Maintaining declarations of conformity and technical documentation for the periods required by medical device regulations, and providing these documents to the local regulator upon request.
Ensuring 24/7 Connectivity
Maintaining continuous (24/7) communication and contacts between regulatory authorities, distributors, the monitoring representative, and the manufacturer.
Consultations
Providing guidance on legislation regarding medical device circulation in Kazakhstan and the EAEU.
Mail Monitoring
Monitoring emails for incoming notifications and forwarding relevant messages to the regulatory authority, with daily reporting of devices to be monitored.
Quarterly Reporting
- Providing quarterly reports on monitoring literature and online resources for adverse event notifications.
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