Conformity assessment of medical devices

According to Resolution of the Cabinet of Ministers from October 2 2013р. #753, all types of healthcare products must be assessed in compliance with the following technical regulations:

  • Technical regulation regarding healthcare products approved by Resolution of the Cabinet of Ministers from 02.10.2013 #753;
  • Technical regulation regarding healthcare products for in vitro diagnostics, approved by Resolution of the Cabinet of Ministers from 02.10.2013 #754;
  • Technical regulation regarding active implanted healthcare products approved by Resolution of the Cabinet of Ministers from 02.10.2013 #755.

Healthcare products can be put on the market only in case if the totally comply with the requirements of Technical Regulations on condition that they are duly supplied, installed, technically served and are used as intended.

The procedure of compliance assessment in accordance with technical regulations depends on the class of the healthcare products.

The eventual result of the procedure is obtaining of the Certificate of Compliance, the Compliance statement and the Technical File.

 

SERVICES

1. Cooperation with authorized representative of the Customer on the territory of Ukraine in terms of working on applications and marking design for the purpose of compliance assessment. Assistance regarding import issues and putting the products on the Ukrainian market.

2. Cooperation with authorized representative of the Customer on the territory of its country in terms of getting information and documents needed to conduct process of compliance assessment of the healthcare products.

3. Management of the experts work on assessment process regarding internal audit of the Manufacturing Company.

- In the course of the procedure of compliance assessment in accordance with technical regulations it is necessary to conduct audit of the Manufacturing Companies. The audit is to be conducted by Ukrainian Auditors.

4. To keep control on timely getting the Certificates of Compliance from the accredited certification institutions within the time frame of 10-14 days from the audit date.

5. To organize the process of translation of the documents provided by Manufacturer in order to present them to certification institutions.

6. To accept financial resources to the company accounts from the Customer for the purpose of work performance.

 

COSTS

Costs for assistance, arrangements and compliance assessment are to be calculated in accordance with the type of healthcare product or medical equipment and safety class of the products.

 

TIME FRAMES

Time to completion is 4-5 weeks starting from the moment of getting the complete package of the documents from the Manufacturer (all the necessary certificates and technical files).

Also the time frame depends on timely arrangement of the dates and terms of carrying out the audit of the Manufacture by Ukrainian experts.

 

LIABILITY

Liability of «EASTERN INDUSTRIAL GROUP» LLC is to be executed after passing original of the Certificate of Compliance, the Compliance statement and the Technical File to the Customer. The original documents are to be kept for 5 years.

«EASTERN INDUSTRIAL GROUP» LLC guarantees confidentiality and nondisclosure of information to the third party.