Labelling in Russian market medical devices
All medical devices circulating within the territory of the Russian Federation are subject to safety monitoring. One of the common violations found during such monitoring activities is the failure to identify the device in question. Each medical device should be clearly identified; all sales should be made only under the trade name stated in the marketing authorization document and in accordance with the information provided in the master file (application dossier).
Labelling is the main identification of the medical device. Therefore, it is crucial to know and implement key labelling requirements during manufacturing of the MD.
The requirements applicable to the labelling of MD authorized for circulation within the territory of the RF are summarized in the following regulation:
- GOST R 50444-92 MEDICAL DEVICES, APPARATUSES AND EQUIPMENT. General specifications
- GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements.
- GOST R ISO 15223-2-2013 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2. Symbol development, selection and validation.
- Resolution of the Government of the Russian Federation No. 55 dated Jan 19, 1998 “On the establishment of sales rules for certain groups of goods, the list of durable goods, for which the requirement of the buyer for provision of equal goods free of charge in the event of repairs or for replacement at no cost with analogous goods is not applicable, and on the establishment of the list of non-food goods of appropriate quality which should not be returned to the seller or exchanged for analogous goods of another size, form, dimensions, model, colour or specifications”.
- The Law of the RF No. 2300-1 dated Feb 07, 1992 “On the protection of consumers’ rights”.
- Resolution of the Government of the Russian Federation No. 1037 dated Aug 15, 1997 “On actions to ensure the availability of information written in Russian on non-food goods imported into the Russian Federation”
- Particular requirements of specific standards applicable to medical devices (for example, standard GOST R ISO 18113 lists labelling requirements for medical devices used for in vitro diagnostics).
Considering the aforesaid, the following key information may be highlighted in the regulations mentioned:
- any medical device should be marked and labelled in accordance with its related marketing authorisation and master file data
- any medical device should have marking provided in Russian (possibly supported with the text in another language(s))
- marking on the medical device must be durable enough to stay readable during the service life term (expiration term) of the MD concerned, as per the related manufacturer’s indication; the methods of such marking and label manufacturing (i.e., labels, packing etc.) should consider the specific features of the medical device labelled and should always ensure the sufficient quality of the identification image.
- Minimal information to be included in the medical device marking should be as follows:
– number of the marketing authorization and the date of registration;
– name of the medical device;
– denomination of the model (type, article no., sort etc./) and/or implementation of the medical device, list of components (if applicable);
– name, trade mark (if applicable), location (legal address) of the manufacturer, address of the manufacturing facility;
– information regarding indications for use of the MD concerned , its usage and effect, contraindications or limitation of use (considering the specific features of each particular type of medical device); the applicability of this paragraph should be considered individually for each device concerned;
– main properties and specifications of the medical device as stated in the International System of Units;
– expiration date (month, year) or service life as per the manufacturer’s information;
– specific storage conditions and/or operational conditions (if applicable);
– indication of sterility along with the method of sterilization (for sterile medical devices).