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 №229 dated 26.09.2000 “Order of the State registration of the medical devices in Ukraine ” [download in Ukrainian]

That Order, same as Decree №1497, 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.

Important! Currently there are two legal acts regulate the procedure of the State registration of medical devices: Decree of Cabinet of Ministers №1497 and Order of Ministry of Health of Ukraine №229. Decree of Cabinet of Ministers has more legal power than Order of Ministry of Health of Ukraine , for that reason all disputes between these two acts are solved in favor of Decree.

3. Decree of Cabinet of Ministers of Ukraine №780 dates 02.06.2003 “About State agency (authority) of medicinal products and medical devices” [download in Ukrainian] .

That Decree describes responsibilities, right and authorization of the State agency (authority) of medicinal products and medical devices.

There are many other legal acts, decrees, orders and directives that have indirect relation to the procedure of State registration of medical devices in Ukraine . If you are interested in consulting services regarding valid legislation in the field of legislation on registration, import and sale of the medical devices – please do not hesitate to contact us.

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;