BACR | Bulgarian Legislation

Bulgarian Legislation

Constitution of The Republic of Bulgaria - Art. 29, para 2

Medical Devices Act (19.02.2016)

Medicinal Products in Human Medicine Act (07.06.2016)

ORDINANCE on the Essential Requirements and the Procedures for Conformity Assessment to the Essential Requirements for Medical Devices Referred to in Article 2, paragraph 1 (3) of the Medical Devices Act

ORDINANCE № 10 of 2008 on the Documents Required from the principal/Coordinating Investigator or Sponsor for Obtaining an Ethics Committee Statement and on the Procedure for Safety Monitoring of Medical Devices during Clinical Investigations and Assessment of the Clinical Data Collected during such Investigations

Personal Data Protection Act