ECOHYNTOX CAB assesses conformity of medical devices in accordance with the Technical regulations on medical devices («Про затвердження Технічного регламенту щодо медичних виробів») approved by the Ordinance of the Cabinet of Ministers of Ukraine dated 02 October 2013 No. 753 according to the procedure P.9.3.03 Assessment of Conformity to Technical Regulations (download).
According to the requirements of the Annex 2 of the Technical regulations on medical devices approved by the Ordinance of the Cabinet of Ministers of Ukraine dated 02 October 2013 No. 753 and DSTU 4388:2005 medical devices are classified with dependance on potential risk of their use.
Product Conformity Assessment Process
Type Check
Type Check involves:
- Submission of the application and required documents (download);
- Expert evaluation of the documents provided by the manufacturer, check of the device sample in terms of conformity to technical documentation; determination of the elements constructed in accordance with the respective standards which conform to the European harmonised standards, and voluntary application of which may be perceived as evidence of conformity of devices to the Technical Regulations, as well as recognition of elements constructed without application of respective provisions of the given standards;
- Carrying out or assurance of respective checks and tests necessary to find out whether the decisions taken by the manufacturer conform to the Technical Regulations if the manufacturer has filed to apply national standards which conform to the European harmonised standards, and voluntary application of which may be perceived as evidence of conformity of devices to the Technical Regulations;
- Carrying out or assurance of respective checks and tests necessary to find out whether respective standards chosen by the manufacturer for application have been applied;
- Approval of the place of the given checks and tests by the applicant;
- Issue of the type check certificate.
Product Check
Product Check involves:
- Submission of the application (download) and required documentation (information on respective products; technical documentation on the checked product type, and copy of the product type check certificate (except for Class IIa));
- Expert evaluation of technical documentation;
- Approval of the place of the studies and tests by the customer;
- Carrying out or organisation of sample drawing and identification;
- Organisation of tests;
- Decision on the possibility of issue of the product conformity certificate.
Procedure for Assurance of Operation of the Comprehensive Quality Management System
Performing Procedure for Assurance of Operation of the Comprehensive Quality Management System involves:
- Submission of the application (download) for conformity assessment, application for certification of the quality management system and required documentation;
- Expert evaluation of technical documentation and documentation pertaining to the quality management system;
- Audit of the quality management system;
- Decision on the possibility of issue of the certificate of conformity and for the quality management system;
- Supervision.
