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Self-declaration Services. Declaration of Conformity


Private enterprise "POLITOKS" offers Services for the self-declaration of medical devices to the requirements of technical regulations

The procedure of self-declaration to technical regulations is applied for:

- I class medical products are not sterile, without measurement function;

- In vitro diagnostic medical devices that are not included in the “A” and “B” list of Technical Regulation No. 754, and are not self-checking products.

To undergo the procedure of self-declaration it is necessary:

Get the Power of Attorney as an authorized representative of the manufacturer in Ukraine and form the Technical file, which, according to the requirements of the Technical Regulations, includes:

a general description of the medical product, including any planned modifications to such a product, as well as its intended use; design drawings, information about the methods of manufacturing the specified medical device, as well as diagrams of components, components, circuits, etc., and descriptions necessary for an understanding of the specified drawings, diagrams and operation of the medical device;

the results of the risk analysis, information on standards applied in whole or in part, from those included in the list of standards that comply with European harmonized standards and which voluntary application can be taken as proof of compliance of medical devices with the requirements of the Technical Regulations for Medical Products, as well as a description of solutions, adopted in order to fulfill the requirements of the Technical Regulations regarding medical devices in the case of partial application of those specified in the standard s, the results of the project design calculations and checks. If the medical device is intended to be connected to other medical devices for the purpose of its intended use, confirmation of compliance with the requirements of the Technical Regulations on Medical Products is provided, provided that it is connected to other medical devices; the results of preclinical evaluation; results of clinical assessment; label and instructions for use.

Authorized Representative Required:

Perform translation of manufacturer's documentation into Ukrainian;

Create a Declaration of Conformity with the requirements of the Technical Regulations;

Get a technical file from the manufacturer;

Develop product labeling that would meet the requirements of the Technical Regulations and regulatory documents;

Make the specified products in the register of the State service of medicines and drug control.

PE "POLITOKS" offers services for self-declaration

We compile a list of required documents for the relevant Technical Regulations.

We conduct an examination of the documentation.

We are developing a bilingual (Ukrainian-English) Agreement on the Authorized Representative in Ukraine.

We translate the necessary documents.

We compile the Technical file in accordance with the requirements of the Technical Regulations.

We carry out clinical trials, specialized evaluation of clinical data.

We conduct preclinical evaluation (biomedical testing).

We organize letters for the customs authorities with confirmation of belonging to medical devices.

We are developing a labeling project.

We make a declaration of compliance with the requirements of Technical Regulations.

We are submitting the required set of documents to the State Service for Drugs and Drug Control for entering into the register of persons responsible for introducing medical devices into circulation.

Our experts are qualified to consult you for all questions.

We will be glad to cooperate!