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State Medical Service in Poltava region on the results of market surveillance in 2020 in the field of medical devices, medical devices for in vitro diagnostics, and active medical devices that are implanted

It is reported that the characteristic violations of the requirements of the Technical Regulations identified during the inspections:

  • the indication on the label/package for the sale of the date before which the product can be safely used without deterioration of performance does not meet the established requirements;
  • absence in the instruction on the application of the date of issue or the last date of its revision;
  • there is no national mark of conformity on the label or packaging, as well as on the instructions for use of medical products, the application of which on the products is provided by the technical regulations;
  • the word “Lot” and “Lot Number” are almost missing from the label/packaging for sale due to improper marking;
  • there is no instruction that should accompany the product;
  • the name of the medical device indicated on the package is incomplete;
  • information on the guaranteed service life and non-sterility of the medical device, stated on the packaging/label, does not meet the requirements of the Law of Ukraine “On ensuring the functioning of the Ukrainian language as the state language”;
  • the label/package of the medical device does not contain the data necessary for the identification of the medical device and its safe use;
  • labeling of the label in a foreign language;
  • the address of the authorized representative affixed to the label/package does not coincide with the address indicated in the declaration of conformity;
  • there is no notification from the authorized representative on the introduction of this product in accordance with the order of the Ministry of Health of Ukraine dated 10.02.2017 № 122 “On approval of the Register of persons responsible for the introduction of medical devices, active implantable medical devices and medical devices for in vitro diagnostics in circulation, message forms, list of information stored in it, and mode of access to them”;
  • the manufacturer’s name is incorrect on the label/packaging for sale;
  • the product label does not contain the information necessary for the user or consumer to accurately identify the product and the contents of the package;
  • there is no declaration of compliance with technical regulations;
  • the label of the medical device does not contain the name or trademark and location of the manufacturer and the name and location of the authorized representative;
  • the product label contains information about the level of purity, namely: STERILE R, at the same time in the provided quality certificate in the column “product name according to the Catalog” it is stated that the medical device is “non-sterile”.

The State Medical Service also carried out 7 unscheduled inspections to fulfill the instructions of the central office of the department.

During 1 unscheduled inspection, it was established that the company put into circulation and/or operation and distributed products that do not meet the requirements of paragraphs 9, 16, 43, 44 and paragraphs 42, 44, 47 of Annex 1, Annex 2, paragraph 2 of Annex 3, Annex 11 of the Technical Regulation on medical devices, namely:

  • there is no marking with the mark of conformity to technical regulations;
  • there is no declaration of conformity;
  • the instructions for use do not specify the date of issue or the last date of its revision;
  • in the instruction, there is no marking with a sign of conformity to technical regulations.

Based on the results of the inspection of the above products, Scenario plans for the probability of risk that may pose products were drawn up, on the basis of which it was determined that such products could pose a serious risk and a decision was made to take restrictive (corrective) measures. 28-32 of the Law of Ukraine “On state market supervision and control of non-food products” and Art. 12 of the Law of Ukraine “On General Safety of Non-Food Products”, which defines the withdrawal of products from circulation and the prohibition of providing such products on the market.

According to the results of inspections:

  • 36 acts were drawn up;
  • 36 decisions on taking restrictive (corrective) measures were provided;
  • fines totaling UAH 102,000 were imposed.

It is noted that during the inspections of products with signs of falsification, infringements of intellectual property rights were not detected.

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