Article 45 of “Law of Ukraine On Technical Regulations and Conformity Assessment” stipulates the conditions under which recognition of the results of conformity assessment is possible. Ukrainian conformity assessment authorities are entitled to recognize the results of conformity assessment in case of availability of the relevant agreements with such authorities.
When choosing a recognition procedure, it should be considered that recognition is not unconditional and implies partial carrying out of the procedure.
The main advantages of the recognition procedure:
- absence of factual arrival of Ukrainian auditors to the enterprise;
- there is no need to provide a full set of documentation as in the procedure involving audit;
- timing of the procedure;
- cost savings.
We can also specify a number of disadvantages:
- not applicable to all CE certificates;
- the validity period of the Ukrainian certificate will also be the same as the validity period of the recognized certificate;
Documentation on medical products is submitted to the authority. In case of passing of the recognition, the Ukrainian certificate may include all products specified in CE certificate. It is also possible to reduce the list of products, however, it is impossible to expand it with those products that are not included in the certificate.
The relevant confirmations from the European authority are additionally submitted.
As a result of the completed procedure, a certificate will be issued for the period of validity of the European certificate.
Archimed company possesses necessary experience and knowledge to support the conformity assessment procedure by recognition and is ready to offer you:
- a full range of counselling on issues related to the legalization of medical products on the Ukrainian market;
- assistance in collection, localization and preparation of Technical Documentation, for submission to the conformity assessment authority;
- appointment of an authorized representative;
- assistance in choosing conformity assessment authority and communication with the authority throughout the procedure;
- preparation of a draft declaration of conformity assessment, approval of the certificate and receiving of the original;
You can get more detailed consultation by writing us a short request or by calling the number below.