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The Bulgarian Government Launches Measures Following a few cases of outrageously high prices of medical devices exposed on the TV, the Government has decided to start regulating the medical device business. The objectives are to stop the draining of the Sick Fund and, perhaps, reduce the cases when “top quality products” are sold at crazy prices to patients who need implants. The first step is to create a public list of the medical devices which are subject to reimbursement. The Bulgarian text of the new regulation is available HERE). The next step would be to control the prices of such devices in a way similar to medicines (e.g., through reference pricing). The new regulations will affect mainly the private business of orthopaedic and cardiac surgeons. In Bulgaria, the scope of reimbursement for medical devices is extremely limited. For details, write to pharma@tma-bulgaria.com.
KROS-M, a leading manufacturer of condoms and sex lubricants, certified to ISO 9001:2008 and ISO 13485:2003 A Bulgarian company present on worldwide markets with its top quality products, KROS-M, achieved certification to ISO 9001:2008 and ISO 13485:2003 (for medical devices) for its sex lubricants manufacturing facilities. The Quality Management System has been developed under the guidance of consultants from Top Management Advisors supported by field experts from Revolt-64. The certification body has been Lloyd’s Register Quality Assurance which operates in Bulgaria according to its highest international standards. Manufacturing medical devices for healthy people is a special challenge reflected in the exclusive care for the quality of the products which must guarantee the health and the satisfaction of the final consumers. Some additional information is available HERE. |
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