ROSZDRAVNADZOR

ROSZDRAVNADZOR registration Certificate is an official document given out on medical equipment, tools and materials on basis of results of corresponding tests and estimations confirming quality, efficiency and safety of products. Only after its reception production of medical appointment may be used in public health services.

Document is given out by Federal Agency of supervision in sphere of public health services and social development (ROSZDRAVNADZOR) on basis of the Order of Ministry of Health and social development of Russian Federation from October, 30th, 2006 N 735 "About the statement of Administrative regulations of Federal Agency of supervision in sphere of public health services and social development on execution of state function on registration of products of medical appointment".

Registration certificate period of validity is not limited.

Centre of Production Certification "Standards-group" will assist in preparation of necessary documents and passage of registration of a product of medical appointment.

To register a product it is possible:

• Addressed to a legal person;
• Addressed to an individual businessman specified in the statement for registration.

Terms of reception of the document: Consideration of documents and decision-making on registration of a product of medical appointment, is carried out till 4 months from the date of giving a complete set of documents. If it is required to perform additional tests term may be increased for 3 months.

Products obligatory to registration:

• All products of medical appointment assumed to medical application in the territory of Russian Federation and including devices, apparatuses, tools, devices, complete sets, complexes, systems with software, dressing and seam means, stomatologic materials and so forth;
• Certificate on medical equipment, as well as Certificate on medical tools, Certificate on medical materials is obligatory;
• software which diagnostics apply in medical purposes,intended to preventive maintenance, treatments of diseases, rehabilitations, carrying out of medical procedures and so forth.

Medical certification demands following documents:

• statement for registration of a product of medical appointment;
• document testifying to payment of state tax;
• inquiry on a product of medical appointment;
• documents confirming registration of the organisation-manufacturer as a legal person;
• letter of attorney or a certified copy of the contract in case if the applicant is not a manufacturer of the product of medical appointment;
• documents confirming conformity of production conditions of a product of medical appointment to requirements of legislation of Russian Federation;
• project of a standard document together with documents confirming conformity of a product of medical appointment to its requirements, either requirements of specifications, or standards;
• operation manual on a product of medical appointment;
• project of instruction on medical application at registration of physiotherapeutic devices and reagents (sets) for diagnostics (in vitro), independently used by the end user;
• documents confirming equivalence or identity of product of medical appointment to analogue;
• Results of technical tests, estimations of safety and medical tests of efficiency and safety of the product of medical appointment.

It is necessary to have in view of:

All documents for registration of product of medical appointment should be represented in Russian, or have a certified translation into Russian.