Name of law Law amending and supplementing the law on medical devices Named Bill a bill amending and supplementing the law on medical devices date of acceptance 11/05/2011 number/year Official Gazette 39/2011 Decree No 101

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on medical devices, adopted by the National Assembly of the HLI 11 May 2011

Issued in Sofia on May 17, 2011.

The President of the Republic: Georgi Parvanov

Stamped with the State seal.

Minister of Justice: Margarita Popova

LAW

amending and supplementing the law on medical devices (official SG. 46 2007; amend., 110/2008, no. 41 and 82 from 2009 and no. 98 of 2010.)

§ 1. Article 30 (a) shall be replaced by the following:

"Art. 30. (1) the drug agency maintains on its website a list of devices that can be paid with funds from the budget of the national health insurance fund from the State budget, beyond the scope of the compulsory health insurance from the State budget through the budget of the Ministry of labour and social policy, the budget of establishments under art. 5 of the law on medical institutions, as well as by means of the hospitals with State and/or municipal participation under art. 9 and 10 of the law on medical institutions.

(2) the list under para. 1 contains:

1. General credentials and performance of the medical device;

2. certification and registration status of the medical device;

3. commercial information, including the selling price for the medical device, as well as for the manufacturer/authorized representative or salesperson of the medical device;

4. the value of art. 30 (b), para. 1.

(3) the conditions and procedures for inclusion in the list under para. 1 and for maintaining it are determined in the Ordinance of the Council of Ministers, adopted on a proposal from the Minister of health and Minister of labour and social policy.

(4) shall not be paid for with funds in al. 1 medical devices outside of the list under para. 1. "

§ 2. Art is created. 30 (b):

"Art. 30 (b) (1) the State annually sets the value to which the paid medical devices included in the list under art. 30 (a), para. 1.

(2) the methods for determining the value of medical devices under para. 1 shall be determined by the Ordinance under art. 30 (a), para. 3. "

§ 3. In § 1 of the additional provisions establishes that:

 "29." sale price "is the price per unit or for a certain amount, including value added tax and all other taxes and fees, on which the medical device is available to the user."

Final provisions

§ 4. Within two months of the entry into force of this law the Council of Ministers shall adopt Ordinance referred to in art. 30 (a), para. 3. § 5. The law shall enter into force on 1 January 2012.

The law was passed by the National Assembly 41-Otto on May 11, 2011 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

5939