Compliance assessmen
Registration of medical equipment and medical products. Medical products - devices, complexes, equipment, devices, devices, instruments, systems, implants, accessories, materials or other products, including invasive medical devices and medical products for in vitro diagnostics.

All medical products imported into the territory of Ukraine must undergo the procedure of assessing compliance with the Technical Regulations in accordance with the resolutions of the Cabinet of Ministers No. 753, No. 754, No. 755 dated 02.10.2013.

The procedure for assessing compliance with the Technical Regulations is as follows:
Depending on the class of the medical product, the need to involve a certain conformity assessment body is determined: for the 1st class self-declaration procedures (non-sterile, without measuring functions) are sufficient. For other medical devices (IIa, IIb, III classes) it is necessary to undergo either the procedure of examination of documentation and inspection of production, receiving a certificate for a period of 5 years, or pass the batch conformity assessment procedure by obtaining a certificate for a specific batch. (cannot be applied to sterile products.)
To obtain a certificate of conformity assessment for a period of 5 years (with production inspection) it is necessary:
  • Appoint an authorized representative of the manufacturer in Ukraine;
  • Choose a combination of procedures, in accordance with the class of potential risk of using the medical product, the manufacturer's documentation and other factors;
  • Create a Technical File in accordance with the requirements of the relevant regulation;
  • Prepare a statement;
  • Choose an authorized body for conformity assessment and submit documents, pay for the work of the authorized body;
  • Go through the documentation examination procedure, respond to comments (if any);
  • Agree on objects, dates and inspection plan;
  • Organize a visit of inspectors to production (minimum of 2 people);
  • Eliminate comments received as a result of the inspection (if any);
  • Obtain a decision of the body on the quality management system of the production site;
  • Obtain a certificate of assessment of compliance of medical products with the requirements of the Technical Regulations;
  • Issue a Declaration of Conformity in accordance with the requirements of the Technical Regulations;
  • Apply the mark of conformity and the identification number of the body on the marking of the medical product, make sure that others labeling requirements and instructions meet the requirements of the Technical Regulations and current legislation.
Batch conformity assessment procedure:
  • Appoint an authorized representative of the manufacturer in Ukraine;
  • Create a package of documentation and a statement in accordance with the requirements of the relevant regulation;
  • Choose an authorized body for conformity assessment and submit documents, pay for the work of the authorized body;
  • Pass the procedure of examination of documentation and testing of samples;
  • Obtain a certificate of conformity assessment of a batch of medical products in accordance with the requirements of the Technical Regulations;
  • Issue a Declaration of Conformity in accordance with the requirements of the Technical Regulations;
  • Apply the mark of conformity and the number of the body on the labeling of the medical product, make sure that other requirements labeling and instructions meet the requirements of the Technical Regulations and current legislation.
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