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Registration medical products

State registration of medical device is a state procedure to ensure that only quality and safe medical devices are introduced into the Russian market.

Article 38, paragraph 4, of the Federal Law dated November 21, 2011 № 323-FZ “On Fundamentals of Healthcare of the Russian Federation Citizens” establishes that medical devices registered by an authorized federal executive body in accordance with the procedure, set by the Government of the Russian Federation are allowed for circulation on the territory of the Russian Federation.

The procedure of the state registration is approved by the Resolution of the Government of the Russian Federation dated by August 12, 2014 №1416 “Approval of regulation of the State Registration of Medical Devices”, the Administrative Regulation of the Federal Service on surveillance in healthcare in Terms of Provision of the State Service of Registration of Medical Devices approved by the Order of the Ministry of Health of the Russian Federation dated October 14, 2013 № 737н.

The definition “State registration of medical devices” includes:

- state registration of medical devices;

- making amendments to the registration certificates;

- issue of a duplicate of the registration certificates;

- making amendments to registration documents;

- replacement of the registration certificates;

- cancellation of state registration.

Any instruments, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the application of these products for their intended purpose, including special software, and intended by the manufacturer (producer) for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body, conducting medical research, restoration, substitution or alteration of the anatomical structure or physiological functions of the human body, prevention or termination of pregnancy, the functional purpose of which is not implemented by pharmacological, immunological, genetic or metabolic effects on the human body (hereinafter – the medical products) are subject to marketing authorization.
Medical products manufactured according to individual orders of patients, which are subject to special requirements for the appointment of medical personnel and which are intended solely for individual use by a specific patient, are not subject to marketing authorization.
The marketing authorization of medical products is carried out by the Federal Service for Surveillance in Healthcare (hereinafter - Roszdravnadzor).
The marketing authorization of medical products is carried out based on the results of technical tests, toxicological studies, clinical trials, which basically are the forms of conformity assessment of the medical products, with due regard to classification based on the potential risk of their use, and examination of the quality, efficiency and safety of medical products, potential risk of their use, as well as tests for the approval of the type of measuring instruments (regarding medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, a list of which is approved by the Ministry of Health of the Russian Federation).
The document confirming the fact of marketing authorization of a medical product is the registration certificate for a medical device (hereinafter - the registration certificate). The form of the registration certificate is approved by the registration authority.
In order to carry out the marketing authorization of the medical product, the developer, manufacturer (producer) of the medical product or an authorized representative of the manufacturer (producer) (hereinafter referred to as the applicant) shall submit or send to the registration authority an application for the marketing authorization of a medical product, as well as the following documents:
a) a copy of the document confirming the authority of the manufacturer’s (producer’s) authorized representative;
b) information on the regulatory documentation for a medical product;
c) manufacturer’s (producer’s) technical documentation for the medical product;
d) manufacturer’s (producer’s) operational documentation for the medical product, including the instruction manual or the operation manual for the medical product;
e) photographic images of the general appearance of the medical product together with accessories necessary for the intended application of the medical product;
f) documents confirming the results of technical tests of the medical product;
g) documents confirming the results of toxicological studies of a medical product, the use of which implies the contact with the human body;
h) documents confirming the results of medical product’s testing for the purpose of approving the type of measuring instruments (regarding medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, a list of which is approved by the Ministry of Health of the Russian Federation) The list of medical devices related to measuring instruments, attached to the file "Measuring list");
i) a list of documents;
k) information confirming the clinical effectiveness and safety of medical products (if available);
k) draft plan for clinical trials of a medical product with supporting materials (if available)
In the event that the documents listed above are drawn up in a foreign language, they should be presented with a certified translation into Russian in accordance with the established procedure.
The “Authorized representative” of the manufacturer (producer)" is a legal entity registered within the territory of the Russian Federation authorized by the manufacturer (producer) of the medical product to represent his interests with reference to the distribution of the medical device within the territory of the Russian Federation, including the issues of conformity assessment procedures and marketing authorization, in whose name the registration certificate for a medical device may be issued.
The scheme of the registration process is attached.
The requirements for the technical and operational documentation of the manufacturer are presented in the attached Order 11 н.