BMI View: Bulgaria represents one of the smallest medical device markets in the EU. We expect it to register a mid single-digit local currency CAGR over the 2015-2020 period. The market is largely reliant upon imports which are primarily sourced from other EU member states. Market growth will be dependent upon increasing healthcare funding and the success of efforts to develop the private sector.

BMI Industry View ................ 9

Table: Projected Medical Device Market, 2015-2020 ....... . 9

Latest Updates and Key Forecasts ................ 9

SWOT ................ 10

Medical Device Market ........... 10

Industry Forecast ............... 12

Medical Device Market Forecast ................. 12

Latest Updates .. 12

Structural Trends ................. 14

Table: Detailed Medical Device Market By Product Area, 2010-2020 (USDmn).... . . 15

Consumables Market Forecast . 19

Latest Updates .. 19

Structural Trends ................. 21

Bandages & Dressings .......... 21

Suturing Materials ............... 21

Syringes, Needles & Catheters  21

Other Consumables .............. 22

Table: Consumables Market, 2010-2020 (USDmn)...... . . . 23

Table: Consumables Market, 2011-2020 (USDmn % Change)..... . . . . . . 24

Diagnostic Imaging Market Forecast ........... 25

Latest Updates .. 25

Structural Trends ................. 27

Electrodiagnostic Apparatus .. 27

Radiation Apparatus ............. 28

Imaging Parts & Accessories .. 28

Table: Diagnostic Imaging Market, 2010-2020 (USDmn)...... . . . 29

Table: Diagnostic Imaging Market, 2011-2020 (USDmn % Change)..... . . . . . . 30

Dental Products Market Forecast ................ 31

Latest Updates .. 31

Structural Trends ................. 33

Capital Equipment ............... 33

Instrument & Supplies ........... 34

Table: Dental Products Market, 2010-2020 (USDmn)...... 34

Table: Dental Products Market, 2011-2020 (USDmn % Change)..... . . . 35

Orthopaedics & Prosthetics Market Forecast . 36

Latest Updates .. 36

Structural Trends ................. 37

Fixation Devices .................. 38

Artificial Joints . 38

Other Artificial Body Parts .... 38

Table: Orthopaedics & Prosthetics Market, 2010-2020 (USDmn)..... . . . 39

Table: Orthopaedics & Prosthetics Market, 2011-2020 (USDmn % Change).... . . . . . . 39

Patient Aids Market Forecast ... 40

Latest Updates .. 40

Portable Aids ... 42

Therapeutic Appliances ......... 42

Table: Patient Aids Market, 2010-2020 (USDmn)...... . . . . 43

Table: Patient Aids Market, 2011-2020 (USDmn % Change)...... 44

Other Medical Devices Market Forecast ....... 45

Latest Updates .. 45

Structural Trends ................. 46

Table: Other Medical Devices Market, 2010-2020 (USDmn)...... 47

Table: Other Medical Devices Market, 2011-2020 (USDmn % Change)..... . . . 48

Annual Medical Device Imports .................. 49

Table: Medical Device Imports By Product Area, 2011-2015 (USD000s)..... . . 53

Table: Medical Device Imports By Product Area, 2011-2015 (Local Currency 000s).... . . . . 54

Table: Top 20 Medical Device Suppliers, 2015 (USD000s)...... . . 56

Table: Detailed Medical Device Imports By Product Area, 2011-2015 (USD000s).... 57

Table: Detailed Medical Device Import Trends By Product Area, 2015..... . . . . 61

Table: Detailed Leading Medical Device Suppliers By Product Area, 2015 (USD000s).... . . 65

Monthly Medical Device Imports ................. 69

Table: Monthly Medical Device Imports By Product Area, Year Ending September 2016 (USDmn)... . . . . 69

Annual Medical Device Exports .................. 70

Table: Medical Device Exports By Product Area, 2011-2015 (USD000s)..... . . 74

Table: Medical Device Exports By Product Area, 2011-2015 (Local Currency 000s).... . . . . 75

Table: Top 20 Medical Device Destinations, 2015 (USD000s)..... . . . . . . 77

Table: Detailed Medical Device Exports By Product Area, 2011-2015 (USD000s).... 78

Table: Detailed Medical Device Export Trends By Product Area, 2015..... . . . . 81

Table: Detailed Leading Medical Device Destinations By Product Area, 2015 (USD000s)...84

Table: Detailed Medical Device Trade Balance, 2011-2015 (USD000s)..... . . . 88

Monthly Medical Device Exports ................. 91

Table: Monthly Medical Device Exports By Product Area, Year Ending September 2016 (USDmn)... . . . . 91

Industry Risk/Reward Index ................. 92

Table: CEE Medical Device Risk/Reward Index, Q217...... . . . . . . 93

Market Overview ................ 94

Medical Device Market Overview ................ 94

Table: Medical Device Market, Key Ratios, 2016...... . . . . . 94

Table: Medical Device Market By Product Area, 2016...... . . . . . . 95

Healthcare Overview .............. 96

Health Status .... 96

Healthcare System ................ 97

Private Healthcare Provider .. 98

Healthcare Funding .............. 99

Healthcare Resources ......... 101

Healthcare Activity ............. 102

Healthcare Personnel ......... 102

Key Healthcare Data .......... 103

Table: Key Healthcare Data, 2011-2016....... . . . . . 103

Industry Trends & Developments ...... 105

Regulatory Development . 111

Medical Device Regulations .. 111

Competent Authority ........... 111

Notified Bodies .................. 111

Regulations .... 111

EU Medical Device Regulations ................ 112

Designated Authorities ........ 112

Existing AIMDD/MDD/IVDMDD Regulations ............... 112

New MDR Regulations ........ 113

MEDDEV 2.7.1 Rev 4 ......... 114

Regulatory Changes For Notified Bodies ... 115

Medical Device Pricing & Reimbursement .. 115

Competitive Landscape ... 116

Domestic Medical Device Production ......... 116

Table: Medical Device Production By Detailed Product Area, 2011-2015 (EURmn).... . . . . 116

National Medical Device Manufacturers ..... 119

Table: Domestic Medical Manufacturers....... . . . . . 119

Centillion ...... 121

Etropal ......... 121

SCH諰LY OPTIX .............. 121

Multinational Medical Device Manufacturers ................. 122

Bovie Medical  122

Multinational Market Activity  122

B. Braun ........ 122

Fresenius Medical Care ...... 123

GE Healthcare .................. 123

Philips HealthTech ............. 123

Siemens Healthineers .......... 125

Smith & Nephew ................ 125

Medical Device Market Access .................. 125

Distribution ... 125

Trade Shows .. 126

Methodology .. 127

Forecast Methodology ........ 127

Trade Code Classifications .. 127

Table: Rearranged HS Trade Codes....... . . . 128

Risk/Reward Index Methodology .............. 131

Table: Medical Devices Risk/Reward Index Indicators...... . . . . . 132

Sources ......... 133

Contact ......... 134