Legislation in the field of registration of medical devices:

All legislation in the field of registration of medical devices you can find at the website of our company. That page is updated frequently.

Currently the following legislation in the field of registration of medicinal products is valid in Ukraine :

1. Decree of Cabinet of Ministers №1497 dated 09.11.2005 “ On approval of the order of State registration of medical devices and devices of medical purpose” [download in Ukrainian]

That decree describes general aspects of procedure of registration of medical devices, list of required documents, terms and definitions, order of the expertise of new registration and renewal of registration.

2. Order of Ministry of Health of Ukraine No. 393 as of 04.08.2005 “On approval of List of medical devices that are objects of state registration (renewal of registration) in Ukraine” [download in Ukrainian].

Order provides list of goods and products that are considered as medical devices in Ukraine.

Listing is presented as table whereas left column is a custom commodity code; right column is a description of the product.

Text of the legal act includes all amendments; last date of revision is 14.04.2008.

3. Decree of Cabinet of Ministers of Ukraine No. 1949 as of 17.01.2003 “On approval of the List of medicinal products and medical devices that are free from VAT tax” [download in Ukrainian].

Decree adopts and specifies list of medical devices that are not objects of value added tax (20%). List is presented as table that corresponds with listing provided by Order 393.

Listing is presented as table whereas left column is a custom commodity code; right column is a description of the product.

Text of the legal act includes all amendments; last date of revision is 09.09.2009.

4. Order of Ministry of Health of Ukraine No. 147 as of 01.07.2005 “On approval of expert authorities” [download in Ukrainian].

Order adopts list of expert authorities that can perform technical and qualification studies of medical devices that are under research and development process; technical studies of medical devices submitted for state registration; safety class assessment; preclinical studies and medical-biological expertise of materials on preclinical studies; laboratory analysis and specialized assessment of registration materials for in-vitro diagnostic medical devices (IVD).

5. Order of Ministry of Health of Ukraine No. 791 as of 06.12.2007 “On approval of healthcare-prophylactic institutions of Ukraine that can participate in clinical studies and specialized expertise of registration materials of medical devices” [download in Ukrainian].

Order adopts list of expert authorities that can participate in clinical studies and can perform specialized expertise of registration materials of medical devices.

6. Order of Ministry of Health of Ukraine No. 314 as of 24.05.2006 “On approval of Rules of clinical studies of medical devices and Typical provisions on Ethic’s committee” [download in Ukrainian].

Order describes general principles of evaluation of clinical studies of medical devices in Ukraine, including studies and expertise that should be performed during registration of medical device.  

7. Letter of Ministry of Health of Ukraine regarding implementation of labeling of medical devices with international graphical symbols EN 980:2003, IDT [download in Ukrainian].

Letter states that starting from 01.02.2008 all medical devices (including devices for IVD) should be labeled with international graphical symbols according to requirements of European Union, EN 980:2003, IDT.

If you are interested in services of our company in the field of state registration of the medical device – you can find the following additional information at our website:

• detailed information about new registration of the medical device;

• detailed information about renewal of registration of the medical device;

• structure of the registration dossier for registration of the medical device;

• contact us;