Obtaining a registration certificate (RC) and the commencement of circulation of a medical device on the Russian market does not relieve the manufacturer or its authorized representative of further regulatory obligations. On the contrary, it is from this moment that systematic efforts to comply with legal requirements begin, including Federal Law No. 323-FZ, Ministry of Health orders, and labeling regulations. Below is a structured list of necessary measures.
1. Marking and operation in the “Honest SIGN” system
Starting in 2025, mandatory labeling will apply to a wide range of medical devices, including implants, diagnostic tools, and high-risk products. Therefore, it is necessary:
- register in the state monitoring system “Honest SIGN”;
- ensure the receipt and assignment of marking codes (Data Matrix) to each unit of goods;
- organize the application of codes on packaging – at the production stage, import or in the warehouse;
- transmit information to the system about the introduction of products into circulation and their disposal within 24 hours from the occurrence of the relevant event.
2. Updating the registration dossier
The manufacturer (authorized representative) is obligated to promptly inform Roszdravnadzor of all significant changes concerning the registered product. Such changes include:
- change of production site;
- adjustment of composition, design or functional characteristics;
- change of name or trademark;
- updating the text of the instructions for use or labeling;
- bringing documentation into compliance with current national standards.
To formally notify the regulator, the Amendment to Registration Dossier (ARD) procedure is initiated. Failure to do so may result in serious consequences, ranging from administrative sanctions to suspension or cancellation of registration.
3. Post-registration monitoring
Manufacturers and authorized representatives (MARs) are required to submit reports on medical devices of the following risk classes:
● 3rd grade
● Class 2b (implantable products only)
This procedure is aimed at monitoring the safety and effectiveness of medical devices after they are released onto the market.
Compliance with these requirements helps maintain the legal status of products on the market, minimize regulatory risks, and ensure patient safety in accordance with current legislation.
