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:
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:
What you get after all the certification procedures?
Declaration of conformity replaces the registration certificate at the customs clearance of medical products.