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Professional approach to the certification of medical products
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г. Киев, ул. Саксаганского, 52а, 2 этаж, офис 6 csplus29@ukr.net csplus29@gmail.com

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Medical devices conformity assessment procedure

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PE “Consulting service plus” offers services for medical products conformity assessment in the authorized facility.

Conformity assessment of medical devices with the assistance of the authorized body for conformity assessment is required for completing the procedure for:

  • Medical Products Is (sterile), I with measuring function, IIa, IIb, III classes.
  • The reagents, calibrators and controls included in the list of "A" and "B"
  • Active implantable medical devices.

Conformity assessment with the assistance of the authorized body is:

  • Certification of the quality management system of production site.

The result is a certificate of conformity assessment of the medical device (5 years) and a certificate for quality management system (for 3 years).

  • On-party conformity assessment.

The result is a certificate for a specific part (supplied) medical devices. In this case, the examination is carried out by the manufacturer provided documentation, a typical example of a medical device for compliance with the technical documentation is verified, the tests are conducted which are needed to determine the appropriate standards, which were chosen by the manufacturer. On-party conformity assessment does not apply to sterile products.

Application, documents and a letter of guarantee are submitted in one of the authorized conformity assessment facilities, which may be different by the composition of experts and inspectors, which can significantly affect the time limits and other aspects of the procedure. Body Selection of conformity assessment is an important and responsible decision that can significantly affect the time limits and cost of certification.

To obtain conformity assessment certificate it is necessary to:

  • Get the power of attorney for the authorized representative of the manufacturer in Ukraine.
  • Form a Technical file as required by the relevant regulations;
  • Form an application form and check-list. The application must include:
  1. Information about the name and location of the manufacturer and any additional manufacturing sites covered by the quality management system;
  2. Information about medical products or medical devices category in respect of which the assessment will be carried out;
  3. Quality management system documentation;
  4. Manufacturer should comply with the requirements stipulated by the approved quality management system;
  5. Manufacturer should keep in appropriate and suitable for work/use condition the state-approved quality management system;
  6. Manufacturer should systematically analyze the experience obtained from the use of medical devices after their introduction into circulation, 
  • Conduct clinical trials, specialized evaluation of clinical data.
  • Translate manufacturer’s documentation into Ukrainian language.
  • Obtain a certificate of requirements of the Technical Regulations conformity assessment of medical device.
  • Make Technical Regulations Declaration of compliance.
  • Apply a conformity mark and identification number of the authorized body on the medical device marking.

Enterprise quality management system is subject to surveillance audits, which according to the standard DSTU ISO 13485:2005 should be carried out annually. Conformity assessment body needs to carry out periodic checks and evaluations in order to make sure that the manufacturer applies the approved quality management system and also it needs to provide the manufacturer a report on such activities.

The manufacturer should in advance inform the authorized body about any significant planned changes in the production list or its safety, about quality management system changes.
Upon receipt of the Certificate of Conformity, Declaration of Conformity is made up, which is used by customs and accompanies goods in circulation.

We offer a range of services that allows minimizing the financial costs and certification time limits: 

  • Organize the passage of a conformity assessment procedure approved by the Technical Regulations in the authorized facilities.
  • We carry out examination of the dossier and make a declaration of conformity.
  • Conduct clinical trials, specialized evaluation of clinical data.
  • Develop a bilingual (English-Ukrainian) Agreement on Authorized Representative in Ukraine.
  • Translate necessary documents.
  • Compile the Technical file as required by the Technical Regulations.
  • Select the conformity assessment authorized body, submit documents, pay the authorized body work, go through the procedure of examination of documentation, respond to comments, coordinate objects, dates and inspection plan.
  • Organize inspectors travel on production.
  • Develop a marking project.
  • Make Declaration of conformity with the Technical Regulations.

High professionalism of our employees and the company's long experience in the field of registration and licensing of medical products enable us to find the optimal solution for the customer in terms of performance and costs, as we have our own accredited centers, laboratories and hospitals.

We look forward to collaborating! 

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Адрес:

г. Киев, ул. Саксаганского, 52а, 2 этаж, офис 6 csplus29@ukr.net csplus29@gmail.com