Registration of Medical Products

Registration Certificate of Ministry of Healthcare 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.

OUR SERVICES:

• help in preparation of documents;
• free consultation on service of registration of medical equipment and medications;
• elaboration of the most optimal scheme of obtaining the registration certificate
• elaboration of technical documentation, execution of necessary certificates (certificate of compliance of GOST R, sanitary-epidemiological conclusion);
• representing of interests of the company-applicant in state registration authorities, organization of documentation follow-up till the moment of registration receipt (if necessary, corrections can be introduced);
• dispatch of the ready order to your office.

Terms and price of registration of medical equipment and medicines: TERMS: Experts of SERCONS will affect all the necessary works in accordance with your request at the earliest possible date.

PRICE: The price of each order is calculated individually as it depends on the type of products to be registered, availability of the necessary documents, degree of compliance of a product and documentation to the established requirements, etc. In order to obtain an approximate estimation of the price and term of execution of the service – registration of medical equipment, please, send an enquiry to our manager.