RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of June 20, 2012 No. 548

About modification of the Procedure for state registration of medical equipment and products of medical appointment

The Cabinet of Ministers of Ukraine decides:

Bring in the Procedure for state registration of medical equipment and products of medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of November 9, 2004 No. 1497 (The Official Bulletin of Ukraine, 2004, No. 45, Art. 2970; 2008, No. 98, Art. 3237, No. 100, Art. 3313; 2010, No. 21, Art. 868, No. 75, Art. 2668; 2011, No. 89, the Art. 3236), changes which are applied.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of June 20, 2012 No. 548

Changes which are made to the Procedure for state registration of medical equipment and products of medical appointment

1. Add Item 2 with the paragraph of such content:

"qualification testing - monitoring test of samples of medical products for evaluating readiness of production to issue such products and determinations of their compliance to requirements of regulating documents.".

2. To exclude the paragraph of the seventh of item 4.

3. State Item 13 in such edition:

"13. Effective period of the certificate is unrestricted.

For medical products which are made in Ukraine and did not pass qualification tests, effective period of the certificate constitutes two years.

If as the integral part enters into structure of medical product medicine, effective period of the certificate is limited to effective period of the registration certificate on such means.".

4. In Item 14:

in paragraph one to exclude the word "also";

add Item with the paragraph of such content:

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