Russia has signed the Agreement on the Common Principles for the Circulation of Medical Devices (Products Intended for Medical Purpose and Medical Technical Equipment) in the Eurasian Economic Community. The Agreement is to enter into force after 1 January 2016.
The Agreement defines “medical devices” in the same way as they are defined by http://pravsky.com/medical-devices/ (Law on the Principles of Citizens’ Health Protection in the Russian Federation, No. 323-FZ of 21 November 2011).
According to the Agreement, all medical devices released onto the Eurasian Economic Community (the Community) market must be registered. For the purposes of registration, the same requirements are to be applied to devices manufactured in the Community and to all imported devices.
The Eurasian Economic Commission is to adopt the rules for the classification of medical devices as well as the common Community requirements pertaining to the safety and efficiency of medical devices.
Placing medical devices on the market
The manufacturers or their authorized representatives are to be responsible for placing medical devices on the market.
It is to be prohibited to place a device on the market, if:
- There is an official notification issued by the relevant authorized state body, the manufacturer and/or its authorized representative that the circulation of the device has been suspended or that it has been taken from the market or taken back by the manufacturer;
- The service period (shelf life) of the device has expired; or
- The device has not been duly registered.
Production of medical devices
The manufacturer must ensure that any applicable requirements pertaining to the implementation and maintenance of quality management are complied with. The detailed requirements are to be adopted separately by the Commission.
The manufacturer must create and maintain the system of collecting and analyzing the data on the use of medical devices as well as the system for detecting and uncovering any side-effects caused by the use of medical devices.
The manufacturer must send to the authorized state bodies regular reports based on the results of clinical trials of certain types of high-risk medical devices. The detailed reporting procedure is to be adopted separately by the Commission.
If the manufacturer discovers that any of its devices do not comply with the applicable safety or efficiency requirements or becomes aware of any circumstances or facts which create a threat to human life or health, it must notify the authorized state body of these facts and circumstances within five days.
If the manufacturer ceases to produce any medical device, then the manufacturer (or its authorized representative) must notify of this fact the state body which issued the registration certificate for this device.
Labelling of medical devices
Manufacturers or their authorized representatives must label all medical devices which have undergone registration with a special “medical devices sign”, before they may place these devices on the market.
The Commission is to develop and adopt detailed labeling requirements for medical devices.