Product re-qualification

cel  Objective: Re-qualification of the product (eg. cosmetic) into the medical device.

dla kogo  For whom: For companies wishing to carry out the change of the intended use of a product.. This applies in particular to the borderline devices or those in which a small modification of the scope of the intended use or the composition allows to qualify the product as a medical device (eg. cosmetics, shoes, bathroom accessories, mattresses, textiles etc.).

zakres  The range of consulting services:

  • verification / evaluation of products belonging to the group of medical devices;
  • defining the conditions and requirements to be met by the product according to the requirements for medical devices,
  • classification of a medical device to the appropriate class - defining boundary conditions.
  • cost estimation of the product re-qualification, including additional research and / or clinical evaluation.
  • preparing the documentation of the medical device (instructions for use, labels)
  • certification (if applicable) and the registration of a medical device in the Office for Registration of Medicinal Products, Medical Devices and Biocides.

korzysci  Benefits:

  • wider range of customers,
  • lower price by reducing the VAT rate from 23% to 8%,
  • opening of new distribution channels (pharmacies),
  • building the confidence in the brand of the product as a medical device.

czas  The time to deliver the service depends on the complexity of the product:

  • type (eg. mechanical, electrical, etc.)
  • class (I, IIa, IIb .III)
  • composition.
Mydlarska 47
04-690 Warsaw

phone: + 48 22 300 54 31
mobile:+48 508 354 544
mobile: +48 791 480 270