Registration of medical devices
Starting from 01.07.2015, the main documents, which regulate the conformity assessment of medical devices requirements of technical regulations, are:
Technical regulations for medical devices:
- Statement №753 of Cabinet of Ministers of Ukraine from 02.10.2013 "Approval of the Technical Regulations for Medical Devices";
- Statement №754 of Cabinet of Ministers of Ukraine from 02.10.2013 "Approval of the Technical Regulations for medical devices for the diagnosis of in-vitro»;
- Statement №755 of Cabinet of Ministers of Ukraine from 02.10.2013 "Approval of the Technical Regulations for implantable medical devices."
Transitional period up to 01.07.2016, when products can be imported with old Registration certificates, which do not comply to Technical Regulations, is fixed with Statement №181 of Cabinet of Ministers of Ukraine from 27.05.2014.
There are two variants for passing through the procedure of conformity of assessment with involving exact certification body:
- Inspection of quality management system of production premises. In case of positive result of inspection, it is possible to obtain certificate for medical product for a period of 5 years, connected with a certificate for quality management system for a period of 3 years.
- Registration of each batch of medical products, therefore certificates will be given for each batch (shipment). Expert inspection and tests of products are necessary.
Depending on class of medical device procedure of conformity of assessment to technical regulations is carried out in different ways.
Class of medical product determines the need to involve a conformity assessment authority.
It is enough to have so called "self-declaration" for the safest products.
For other medical products it is needed to pass through expertise of documentation, expert inspection of production and obtain a certificate for a period of 5 years for serial products, or certificate for a single batch.
Following items are needed for obtaining a certificate:
- A list of products
- Technical file (Technical file)
- Power of attorney for representing manufacturer during registration process in Ukraine
IMPORTANT! All the documents must be in Russian/Ukrainian language.
Please, send us your request and our experts will check which certificates are required for the import of your goods to the territory of Ukraine.