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asking-the-right-questions678768 What is the difference between the registration and certification?

Today the medical products registration procedure is canceled and compliance of medical products with the technical regulations procedure has become into operation from 07 July, 2015. Thus, all new products will undergo this procedure.

Medical products, that have undergone state registration, are included into the state register of medical equipment and medical products and is approved for use on the territory of Ukraine, the validity of the certificate on state registration of which is restricted or ends after July 1, 2015 – it is possible to deliver on the registration certificate until 01 July, 2017.

Product certification is the conformity process of product quality standards, established by the legislation requirements in Ukraine. Certification is carried by specifically accredited organizations. Supporting documents are issued on the results of certification – certificates of conformity, declaration of conformity.

What is the validity of the certificate?

Conformity assessment with the assistance of the authorized body provides a choice of two options:

  • By evaluating the quality of the production site management system (inspection), as a result of which conformity assessment on a medical product is issued for a period of 5 years, associated with the certificate on quality management system for a period of 3 years.
  • By the batch conformity assessment, which involves the issuance of a certificate for a specific batch (supply) of medical products as a result of examination of the documentation and testing of product samples.

What are required documents for certification?

The manufacturer (authorized representative) must submit the following documents:
1. A copy of the agreement (power of attorney) to the authorized representative.
2. The technical file.
3. Quality Manual.

What are the stages of certification procedure?

  To obtain a certificate of conformity assessment for a period of 5 years it is necessary to:

  • Obtain an authorized representative of the manufacturer in Ukraine, to perform all related legal formalities.
  • Choose a combination of procedures, according to class, manufacturer’s documentation, and other factors.
  • Form a technical file as required by the relevant regulations; prepare the application form and a check-list.
  • Select the authorized body for conformity assessment and to apply, pay for the work of the authority.
  • Undergo the documentation expertise procedure to respond to the comments.
  • Finalize the object, date and plan of the inspection.
  • Organize inspectors visit on production.
  • Eliminate the comments received as a result of the inspection.
  • Get a decree of the regulatory body on the quality management system of the production site.
  • Get a certificate of conformity assessment of the medical product requirements of the Technical Regulations.
  • Issue a declaration of conformity with the Technical Regulations.
  • Apply conformity mark and the identification number of the regulatory body to the labeling of the medical product; make sure that the other requirements for labeling and instructions (user manual) comply with the requirements of the Technical Regulations and the currents legislation.

  What you get after all the certification procedures?

Declaration of conformity replaces the registration certificate at the customs clearance of medical products.