Assistance in the procedure of self-avowal

You should have the Declaration of compliance in order to implement medical products into the market circulation according to the current legal legislative regulations of Ukraine. The Declaration is issued directly by the manufacturer of the medical product, or its authorized representative in Ukraine, regarding the results of the correspondent procedure of compliance estimation with the requirements of Technical regulations and is the documentary certification of the compliance of the product with the established legislative requirements.

The requirements to medical products depend on their type, the sphere of use and comply with one of three regulations:

• Technical regulation concerning medical products (resolution of CMU №753)
  Current medical products are subdivided into categories I, IIа, IIb and III.
• Technical regulation concerning medical products for diagnostics in vitro (resolution of CMU №754)
  Products for diagnostics in vitro refer to the category “A” and “B”, products for self-control, products intended for characteristic estimation etc.
• Technical regulation №755 concerning active medical products that are implanted (resolution of CMU №755)

The category of medical product demands the scheme of confirmation of its compliance with Technical regulations.

For the safer products (products from I category (unsterile, without functions of measurement) and also products for diagnostics in vitro, that are not included into the categories “A” and “B” and that aren’t used for self-control) the procedure of allowance to the market of medical products is simplified and is limited by self-avowal.

Involvement of the body on compliance estimation for such products is excluded.
But it is necessary to pass several procedures with the appointment of the authorized person in Ukraine, formation of technical documentation (Technical file), preparation of the Declaration of compliance, notifying Gosleksluzhby (State medical service) of Ukraine on the authorized person and categories/description of medical products, provision with the correspondent product labeling etc.
The company 8L GROUP will render you full qualified maintenance of all procedures mentioned above and other accompanying, if necessary.

Please, contact us and we’ll help you to save time and budgets for new opportunities.