Ukrainian legislation

Main documents that regulate procedure of submission, expertise for establishment of registration of medical devices and renewal of registration, necessity of sanitary-epidemiological conclusion and certification of medical devices are: 

1. Decree of Cabinet of Ministers of Ukraine No 1497 as of 08.11.2005 09.11.2005 «On approval of Order of state marketing authorization of medical devices» 
[available in Ukrainian language in MS Word | or at the Pariliament's website]

2. Order of State Inspection No 51 as of 06.05.2010 "On approval of the List of medical devices that are objects of state registration (renewal of registration) in Ukraine" 
[available in Ukrainian language in MS Word | or at the Pariliament's website]

3. Decree of Cabinet of Ministers of Ukraine No 1949 as of 17.12.2003 "On approval of the list of medicinal products and medical devices that are free from VAT tax"
[available in Ukrainian language in MS Word | or at the Pariliament's website]

4. Order of State Inspection No 251 as of 12.08.2010 "On approval of Order of maintanance of State registry of medical devices"
[available in Ukrainian language in MS Word | or at the Pariliament's website]

5. Law of Ukraine No. 4004-XII as of 24.02.1994 "On assurance of sanitary and epidemiological safety of people of Ukraine"
[available in Ukrainian language in MS Word | or at the Pariliament's website]

6. Decree of Cabinet of Ministers of Ukraine No.815 as of 05.08.2009 "On amendments to Order of custom clearance of goods imported to the custom territory of Ukraine and are objects of obligatory certification" 
[available in Ukrainian language in MS Word | or at the Pariliament's website]

 

There are much more specific normative legal acts, letters, guidelines and explanations that have direct or indirect relation to registration and certification of medical devices in Ukraine. 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office