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Post-market surveillance

Post-market surveillance

The interaction between the manufacturer (or authorized representative, AR) and the regulatory authorities of the Russian Federation does not end upon receiving a registration certificate for a medical device.

Once a medical device is introduced into the Russian market, the manufacturer must carry out continuous monitoring of its circulation. This encompasses various responsibilities, such as:

Providing information about each medical device imported into the Russian Federation, within 15 days from the date of import.

Conducting clinical monitoring and submitting an annual clinical monitoring report for medical devices belonging to specific risk classes.

Reporting adverse events, conducting investigations of incidents, and regular reporting to the regulatory authorities.

Informing relevant authorities and entities involved in the circulation about the need for corrective actions at the sites of use.

Implementing appropriate corrective measures in cases where state inspection identifies issues related to the circulation of a medical device.

Conducting analysis and monitoring changes in the products and accompanying documentation, ensuring timely incorporation of necessary modifications into the marketing authorization certificate or dossier.

Monitoring legislative changes and assessing their impact on the products that are already authorized or those to be released to the Russian market.

Failure to perform these post-marketing obligations may result in unscheduled inspections by regulatory authorities, penalties, suspension of organizational activities, or even revocation of registration procedure.

By engaging our post-marketing support services, you can rest assured that your products supplied to the Russian market fully comply with all regulatory requirements.

Why us?

If you are looking for a reliable partner for registration of medical devices, we can offer you high-quality services, flexible individual approach to address your specific tasks, considering all your needs. Furthermore, we ensure swift implementation to meet your timelines.

Our specialists have extensive experience in marketing authorization of medical devices from top global manufacturers.

Our specialists will review your request and answer you within 24 hours

We offer a subscription-based post-marketing support package, which includes comprehensive regulatory assistance throughout the post-marketing stage.

Additionally, we can serve as your Authorized Representative in the Russian Federation and/or the EAEU countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan) during the marketing authorization period, as well as on a regular basis to meet the post-market surveillance requirements.