Technical Regulations of Ukraine emphasize, that it is mandatory to establish functioning a quality
management system (QMS) on the manufacturing site. These requirements of national legislation regarding technical regulation are set up for both national and foreign manufacturers. National legislation highlights the concept of ‘European harmonized standards’, voluntary observance of which is a confirmation of conformity of medical devices with the Technical Regulations concerning medical devices. In thislist, approved by the Order of the Ministry of Economic Development and Trade of Ukraine No. 663 dated June 24, 2015, it is worthy to identify an industry-specific standard for manufacturers of medical products, DSTU ISO 13485:2005.
QMS is compulsory as for the following safety classes of medical devices:
DSTU ISO 13485:2005 is based on the European standard ISO 13485:2003, but the latter has a number of inherent minor particularities. QMS shall be developed and implemented on the enterprise. System certification is not an obligation according to the Technical Regulations and shall be performed upon request of the manufacturer.
It is a compulsory requirement for national manufacturers, who are planning to export their products to the EU market, the availability of the implemented system under the international standard ISO 13485 is a compulsory requirement.
Frequently, an enterprise has a quality management system already, and it requires analyzing and adaptation to meet the requirements of DSTU ISO 13485:2005. Conformity assessment bodies “approve” the QMS and “confirm” the possibility to produce, within the system, products of appropriate quality, which meet the requirements of the Technical Regulation. However, it is possible (at the manufacturer’s discretion) to conduct the QMS certification and obtain a conformity certificate on quality management system accompanying with product conformity certificate.
Cratia renders the following services in:
Budget for QMS development and implementation depends on several issues: