Market Surveillance for medical devices
Market Surveillance for medical devices – nessesary thing for the patient’s healthcare point of view. All market surveillance activities are provided by Roszdravnadzor (Federal Service for surveillance in healthcare).
It consists of:
- Medical device registration process
- Post market surveillance (tracking medical devices once they have been used in the market)
- Government control for circulation of medical products
1 – Medical device must be registered by Russian Government (Roszdravnadzor), without this kind of approval no one can use, sale and do custom clearance of this device. See information how to receive registration certificate – by link.
2 – Post market part of medical product life-cycle (or so called “safety monitoring”) presented by:
- manufacturer’s activities – manufacturer must change information in registration file (dossier) for medical device in case of any changes in product information (see changing process for medical devices) or re-register medical device if changes in current registration certificate couldn’t be done. If manufacturer needs to recall medical device or want to inform Government about accident – he should provide information to department of Roszdravnadzor who is in charge of these activities. Official RZN recommendation – On the procedure for the safety monitoring of medical devices for manufacturers.
- hospital activities – hospital must provide information to Roszdravnadzor when unannounced results of medical device usage took place.
3* – Control Over Circulation Of Medical Device
Control over circulation of medical devices in the territory of the Russian Federation is understood as control over technical testing, toxicity testing, clinical trials, efficiency, safety, production, manufacture, sales, storage, transportation, importation into the territory of the Russian Federation, exportation from the territory of the Russian Federation of medical devices, assembly, setup, application, use including maintenance, repairs, utilization or disposal.
State supervision in the sphere of circulation of medical devices in the territory of the Russian Federation is conducted over compliance with the requirements in the sphere of circulation of medical devices by organizations.
Control is exercised over circulation of medical devices by means of supervisory events including scheduled inspections, as well as unscheduled inspections of entities of circulation of medical devices.
The provision on state supervision of circulation of medical devices is approved by Decree of the Government of the Russian Federation of 25 September 2012 No.970 “About adoption of the provision on state supervision of circulation of medical devices”.
The procedural arrangements of the state control function with respect to legal entities and private entrepreneurs operating in the sphere of circulation of medical devices were established by the Administrative provision of the Federal Service for Surveillance in Healthcare for the implementation of state function involving control over circulation of medical devices and were approved by the order of the Ministry of Healthcare of the Russian Federation of 5 April 2013. No.196n (in force as of 1 November 2013) “About the establishment of Administrative provision of the Federal Service for Surveillance in Healthcare for the implementation of state function involving control over circulation of medical devices”.
* Source – official website of Roszdravnadzor (in Russian by link)
1 – about fines – all information, in case of violations in medical device circulation
2 – Analytics about post market surveillance processes in Russia – safety monitoring review by link