South Africa Medical Device Market, Rules & Regulation, By (Syringe, Needle & Catheter Device, Electro-diagnostic, Imaging Parts & Accessories, Fixation Devices, Dental Products Device, Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film, Scintigraphic Apparatus, CT Scanners, Ostomy Products & Dental Drills)
South Africa medical device market is expected to grow at a CAGR of 8.97 percent during the forecasting period 2018-2024 due to public-private partnerships to develop hospitals, government new health insurance schemes and growing ageing population. It is predicted that ageing population in South Africa will double by 2050 from the present figure. Around 90 percent of the total South African market is mainly contributed by multinational healthcare company. In orthopedics, consumables, prosthetics and patient aids segments, United States is dominating in South African market. However, for cost cutting most of the medical device buyers are looking for Asian countries.
Syringe, Needle & Catheter is dominating segment in South Africa Medical Device Market
Syringe, Needle & Catheter is dominating segment in South Africa Medical Device Market but it is expected that its share will steadily decline in forecasting period 2018-2024. In 2017, Syringe, Needle & Catheter, Electro-Diagnostic and Imaging Parts & Accessories are the top three segments which together hold more than half of the total South Africa medical device market share. The other major segments such as Dental Products, Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film and Dental X-ray contributed in a single digit market share in 2017.
Regulators Set New Licensing Rules for Medical Device Companies
South African Medicines Control Council set new licensing rules on August 24, 2017 for all domestic medical device companies and distributors that they must register with MCC within the specified deadline February 2018. This rule is not applicable for multinational healthcare companies but all medical device importers must obtain MCC licenses.
“South Africa Medical Device Market, Rules & Regulation, By (Syringe, Needle & Catheter Device, Electro-diagnostic, Imaging Parts & Accessories, Fixation Devices, Dental Products Device, Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film, Scintigraphic Apparatus, CT Scanners, Ostomy Products & Dental Drills)” is a market research report published by Renub Research on medical device market of South Africa. This 92 page report with 31 Figures and 3 Tables studies the South Africa medical device market from 5 view points:
1. South Africa Medical Devices Market & Forecast
2. South Africa Medical Devices Market Share & Forecast
3. South Africa Market by (Syringe, Needle & Catheter Device, Electro-diagnostic, Imaging Parts & Accessories, Fixation Devices, Dental Products Device (Total), Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film (flat), Scintigraphic Apparatus, CT Scanners, Ostomy Products, Dental Drills, Others)
4. Rules & Regulation in South Africa Medical Device and IVDs Industry
5. South Africa Medical Device Growth Drivers & Challenges
Medical Device Segments – Market & Forecast
1. Syringe, Needle & Catheter Device
2. Electro-diagnostic
3. Imaging Parts & Accessories
4. Fixation Devices
5. Dental Products Device (Total)
6. Radiation Apparatus
7. Dental Instruments & Supplies
8. Ultra Sound
9. Medical X-ray Film (flat)
10. Scintigraphic Apparatus
11. CT Scanners
12. Ostomy Products
13. Dental Drills
14. Others
This report is useful for those who want to know
Syringe, Needle & Catheter is dominating segment in South Africa Medical Device Market
Syringe, Needle & Catheter is dominating segment in South Africa Medical Device Market but it is expected that its share will steadily decline in forecasting period 2018-2024. In 2017, Syringe, Needle & Catheter, Electro-Diagnostic and Imaging Parts & Accessories are the top three segments which together hold more than half of the total South Africa medical device market share. The other major segments such as Dental Products, Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film and Dental X-ray contributed in a single digit market share in 2017.
Regulators Set New Licensing Rules for Medical Device Companies
South African Medicines Control Council set new licensing rules on August 24, 2017 for all domestic medical device companies and distributors that they must register with MCC within the specified deadline February 2018. This rule is not applicable for multinational healthcare companies but all medical device importers must obtain MCC licenses.
“South Africa Medical Device Market, Rules & Regulation, By (Syringe, Needle & Catheter Device, Electro-diagnostic, Imaging Parts & Accessories, Fixation Devices, Dental Products Device, Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film, Scintigraphic Apparatus, CT Scanners, Ostomy Products & Dental Drills)” is a market research report published by Renub Research on medical device market of South Africa. This 92 page report with 31 Figures and 3 Tables studies the South Africa medical device market from 5 view points:
1. South Africa Medical Devices Market & Forecast
2. South Africa Medical Devices Market Share & Forecast
3. South Africa Market by (Syringe, Needle & Catheter Device, Electro-diagnostic, Imaging Parts & Accessories, Fixation Devices, Dental Products Device (Total), Radiation Apparatus, Dental Instruments & Supplies, Ultra Sound, Medical X-ray Film (flat), Scintigraphic Apparatus, CT Scanners, Ostomy Products, Dental Drills, Others)
4. Rules & Regulation in South Africa Medical Device and IVDs Industry
5. South Africa Medical Device Growth Drivers & Challenges
Medical Device Segments – Market & Forecast
1. Syringe, Needle & Catheter Device
2. Electro-diagnostic
3. Imaging Parts & Accessories
4. Fixation Devices
5. Dental Products Device (Total)
6. Radiation Apparatus
7. Dental Instruments & Supplies
8. Ultra Sound
9. Medical X-ray Film (flat)
10. Scintigraphic Apparatus
11. CT Scanners
12. Ostomy Products
13. Dental Drills
14. Others
This report is useful for those who want to know
- Medical device market in South Africa at present its forecast
- Medical device segments market & its forecast
- Medical device registration process in South Africa
- Growth and Challenges for Medical device segments in South Africa
1. EXECUTIVE SUMMARY
2. SOUTH AFRICA MEDICAL DEVICE MARKET
3. MARKET SHARE ANALYSIS – SOUTH AFRICA MEDICAL DEVICE
4. BY SEGMENTS - SOUTH AFRICA MEDICAL DEVICE MARKET
4.1 Syringe, Needle & Catheter Device
4.2 Electro-diagnostic
4.3 Imaging Parts & Accessories
4.4 Fixation Devices
4.5 Dental Products Device (Total)
4.6 Radiation Apparatus
4.7 Dental Instruments & Supplies
4.8 Ultra Sound
4.9 Medical X-ray Film (flat)
4.10 Scintigraphic Apparatus
4.11 CT Scanners
4.12 Ostomy Products
4.13 Dental Drills
4.14 Others
5. SOUTH AFRICA - MEDICAL DEVICE AND IVD REGULATIONS
5.1 Definitions
5.2 Manner and Conditions for allowing International Tendering
5.3 Importation of Medical Devices and IVDs into South Africa
5.4 Transmission of Medical Devices or IVDs through the South Africa
5.5 License to Manufacture, Import, Export or act as a Distributor or Wholesaler of Medical Devices or IVDs
5.6 Period of Validity of License and Renewal of License
5.7 Appeal against Decision of Council
5.8 Information that must appear in Register for Medical Devices or IVDs
5.9 Amendment to Medical Device and IVD Register
5.10 Classification of Medical Devices and IVDs
5.11 Registration Certificate
5.12 Parts and Components
5.13 Destruction of Medical Devices or IVDs
5.14 Method of taking samples during Investigation, Certificate to be Issued and Reporting of Analysis Results
5.15 Conduct of Clinical Trial and Clinical Investigation
5.16 Adverse Event Reporting and Vigilance for Medical Devices or IVDs
5.17 Investigation
5.18 Offences and Penalties
5.19 Compliance with Requirements
5.20 Advertising of Medical Devices or IVDs
5.21 Labeling of medical device or IVD
5.22 Instructions for use of Medical Device
5.23 Instruction for use of IVD
5.24 Record of Implantable Medical Device and Custom Made Medical Device
5.25 Transitional arrangements regarding Unlicensed Manufacturer, Distributor and Wholesaler
5.26 Transitional arrangements regarding unregistered Medical Devices and IVDs
6. GROWTH DRIVERS
6.1 Point No.
6.2 Increasing Healthcare Expenditure
7. CHALLENGES
7.1 Point No.
7.2 Point No.
2. SOUTH AFRICA MEDICAL DEVICE MARKET
3. MARKET SHARE ANALYSIS – SOUTH AFRICA MEDICAL DEVICE
4. BY SEGMENTS - SOUTH AFRICA MEDICAL DEVICE MARKET
4.1 Syringe, Needle & Catheter Device
4.2 Electro-diagnostic
4.3 Imaging Parts & Accessories
4.4 Fixation Devices
4.5 Dental Products Device (Total)
4.6 Radiation Apparatus
4.7 Dental Instruments & Supplies
4.8 Ultra Sound
4.9 Medical X-ray Film (flat)
4.10 Scintigraphic Apparatus
4.11 CT Scanners
4.12 Ostomy Products
4.13 Dental Drills
4.14 Others
5. SOUTH AFRICA - MEDICAL DEVICE AND IVD REGULATIONS
5.1 Definitions
5.2 Manner and Conditions for allowing International Tendering
5.3 Importation of Medical Devices and IVDs into South Africa
5.4 Transmission of Medical Devices or IVDs through the South Africa
5.5 License to Manufacture, Import, Export or act as a Distributor or Wholesaler of Medical Devices or IVDs
5.6 Period of Validity of License and Renewal of License
5.7 Appeal against Decision of Council
5.8 Information that must appear in Register for Medical Devices or IVDs
5.9 Amendment to Medical Device and IVD Register
5.10 Classification of Medical Devices and IVDs
5.11 Registration Certificate
5.12 Parts and Components
5.13 Destruction of Medical Devices or IVDs
5.14 Method of taking samples during Investigation, Certificate to be Issued and Reporting of Analysis Results
5.15 Conduct of Clinical Trial and Clinical Investigation
5.16 Adverse Event Reporting and Vigilance for Medical Devices or IVDs
5.17 Investigation
5.18 Offences and Penalties
5.19 Compliance with Requirements
5.20 Advertising of Medical Devices or IVDs
5.21 Labeling of medical device or IVD
5.22 Instructions for use of Medical Device
5.23 Instruction for use of IVD
5.24 Record of Implantable Medical Device and Custom Made Medical Device
5.25 Transitional arrangements regarding Unlicensed Manufacturer, Distributor and Wholesaler
5.26 Transitional arrangements regarding unregistered Medical Devices and IVDs
6. GROWTH DRIVERS
6.1 Point No.
6.2 Increasing Healthcare Expenditure
7. CHALLENGES
7.1 Point No.
7.2 Point No.
LIST OF FIGURES
Figure 1-1: South Africa - Medical Device Market (Million US$), 2012-2017
Figure 1-2: South Africa – Forecast for Medical Device Market (Million US$), 2018-2024
Figure 3-1: South Africa - Syringe, Needle & Catheter Medical Device Market (Million US$), 2012-2017
Figure 3-2: South Africa – Forecast for Syringe, Needle & Catheter Medical Device Market (Million US$), 2018-2024
Figure 3-3: South Africa – Electro-Diagnostic Medical Device Market (Million US$), 2012 - 2017
Figure 3-4: South Africa – Forecast for Electro-Diagnostic Medical Device Market (Million US$), 2018 – 2024
Figure 3-5: South Africa – Imaging Parts & Accessories Medical Device Market (Million US$), 2012 – 2017
Figure 3-6: South Africa – Forecast for Imaging Parts & Accessories Medical Device Market (Million US$), 2018 – 2024
Figure 3-7: South Africa – Fixation Medical Device Market (Million US$), 2012 – 2017
Figure 3-8: South Africa – Forecast for Fixation Medical Device Market (Million US$), 2018 – 2024
Figure 3-9: South Africa – Dental Products Medical Device Market (Million US$), 2012 – 2017
Figure 3-10: South Africa – Forecast for Dental Products Medical Device Market (Million US$), 2018 – 2024
Figure 3-11: South Africa – Radiation Apparatus Device Market (Million US$), 2012 – 2017
Figure 3-12: South Africa – Forecast for Radiation Apparatus Device Market (Million US$), 2018 – 2024
Figure 3-13: South Africa – Dental Instruments & Supplies Medical Device Market (Million US$), 2012 – 2017
Figure 3-14: South Africa – Forecast for Dental Instruments & Supplies Medical Device Market (Million US$), 2018 – 2024
Figure 3-15: South Africa – Ultra Sound Device Market (Million US$), 2012 – 2017
Figure 3-16: South Africa – Forecast for Ultra Sound Device Market (Million US$), 2018 – 2024
Figure 3-17: South Africa – Medical X-ray Film (Flat) Device Market (Million US$), 2012 – 2017
Figure 3-18: South Africa – Forecast for Medical X-ray Film (Flat) Device Market (Million US$), 2018 – 2024
Figure 3-19: South Africa – Scintigraphic Apparatus Device Market (Million US$), 2012 – 2017
Figure 3-20: South Africa- Forecast for Scintigraphic Apparatus Device Market (Million US$), 2018-2024
Figure 3-21: South Africa- CT Scanners Device Market (Million US$), 2012-2017
Figure 3-22: South Africa- Forecast for CT Scanners Device Market (Million US$), 2018-2024
Figure 3-23: South Africa- Ostomy Products Medical Device Market (Million US$), 2012-2017
Figure 3-24: South Africa- Forecast for Ostomy Products Medical Device Market (Million US$), 2018-2024
Figure 3-25: South Africa- Dental Drills Medical Device Market (Million US$), 2012-2017
Figure 3-26: South Africa- Forecast for Dental Drills Medical Device Market (Million US$), 2018-2024
Figure 3-27: South Africa- Others Medical Device Market (Million US$), 2012-2017
Figure 3-28: South Africa- Forecast for Others Medical Device Market (Million US$), 2018- 2024
Figure 5-1: South Africa - Health Expenditure (Percent), 2013
Figure 1-1: South Africa - Medical Device Market (Million US$), 2012-2017
Figure 1-2: South Africa – Forecast for Medical Device Market (Million US$), 2018-2024
Figure 3-1: South Africa - Syringe, Needle & Catheter Medical Device Market (Million US$), 2012-2017
Figure 3-2: South Africa – Forecast for Syringe, Needle & Catheter Medical Device Market (Million US$), 2018-2024
Figure 3-3: South Africa – Electro-Diagnostic Medical Device Market (Million US$), 2012 - 2017
Figure 3-4: South Africa – Forecast for Electro-Diagnostic Medical Device Market (Million US$), 2018 – 2024
Figure 3-5: South Africa – Imaging Parts & Accessories Medical Device Market (Million US$), 2012 – 2017
Figure 3-6: South Africa – Forecast for Imaging Parts & Accessories Medical Device Market (Million US$), 2018 – 2024
Figure 3-7: South Africa – Fixation Medical Device Market (Million US$), 2012 – 2017
Figure 3-8: South Africa – Forecast for Fixation Medical Device Market (Million US$), 2018 – 2024
Figure 3-9: South Africa – Dental Products Medical Device Market (Million US$), 2012 – 2017
Figure 3-10: South Africa – Forecast for Dental Products Medical Device Market (Million US$), 2018 – 2024
Figure 3-11: South Africa – Radiation Apparatus Device Market (Million US$), 2012 – 2017
Figure 3-12: South Africa – Forecast for Radiation Apparatus Device Market (Million US$), 2018 – 2024
Figure 3-13: South Africa – Dental Instruments & Supplies Medical Device Market (Million US$), 2012 – 2017
Figure 3-14: South Africa – Forecast for Dental Instruments & Supplies Medical Device Market (Million US$), 2018 – 2024
Figure 3-15: South Africa – Ultra Sound Device Market (Million US$), 2012 – 2017
Figure 3-16: South Africa – Forecast for Ultra Sound Device Market (Million US$), 2018 – 2024
Figure 3-17: South Africa – Medical X-ray Film (Flat) Device Market (Million US$), 2012 – 2017
Figure 3-18: South Africa – Forecast for Medical X-ray Film (Flat) Device Market (Million US$), 2018 – 2024
Figure 3-19: South Africa – Scintigraphic Apparatus Device Market (Million US$), 2012 – 2017
Figure 3-20: South Africa- Forecast for Scintigraphic Apparatus Device Market (Million US$), 2018-2024
Figure 3-21: South Africa- CT Scanners Device Market (Million US$), 2012-2017
Figure 3-22: South Africa- Forecast for CT Scanners Device Market (Million US$), 2018-2024
Figure 3-23: South Africa- Ostomy Products Medical Device Market (Million US$), 2012-2017
Figure 3-24: South Africa- Forecast for Ostomy Products Medical Device Market (Million US$), 2018-2024
Figure 3-25: South Africa- Dental Drills Medical Device Market (Million US$), 2012-2017
Figure 3-26: South Africa- Forecast for Dental Drills Medical Device Market (Million US$), 2018-2024
Figure 3-27: South Africa- Others Medical Device Market (Million US$), 2012-2017
Figure 3-28: South Africa- Forecast for Others Medical Device Market (Million US$), 2018- 2024
Figure 5-1: South Africa - Health Expenditure (Percent), 2013
LIST OF TABLES
Table 2 1: South Africa - Medical Device Market Share (Percent), 2012 - 2017
Table 2 2: South Africa – Forecast for Medical Device Market Share (Percent), 2018 - 2024
Table 3 1: Global - Common Dental Medical Devices, 2017
Table 2 1: South Africa - Medical Device Market Share (Percent), 2012 - 2017
Table 2 2: South Africa – Forecast for Medical Device Market Share (Percent), 2018 - 2024
Table 3 1: Global - Common Dental Medical Devices, 2017
