New service - Registration of Medical Product

Certification authority SERCONS launched a new service - Registration of Medical Products. Registration Certificate is a document that is necessary to obtain for medical products and medical equipment. This certificate confirms the fact of registration of medical products. Medical products cannot be used in healthcare sphere without the registration in the Ministry of Healthcare and Social Development.

Registration Certificate is issued on the name of a legal entity or of an individual entrepreneur that is indicated in the application for the registration. The registration is carried out by the Federal Service on Surveillance in Healthcare and Social Development on the basis of the results of the corresponding tests and evaluations confirming safety, quality and effectiveness of goods.

The list of products and goods that require registration in the Ministry of Healthcare:

• Medicines and pharmaceutical substances;
• Medical equipment and medical goods;
• Perfumery and cosmetic products, oral hygiene remedies;
• BAA (Biologically Active Additives), raw materials for BAA production;
• Specialized food products, baby food;
• Veterinary preparations, agricultural chemicals, disinfection agents;
• Mineral water, energizing drinks

The company SERCONS offers services on execution and issue of registration certificates for medical products, as well as for medical equipment, pharmaceutical raw materials and, directly, for drugs.

Our experts are ready to assist in collection of necessary documents, follow-up documentation consideration by different authorities, execution of corrective actions, if necessary.

More information…