South Africa Medical Device Market, Rules, and Regulations 2018-2024: Public-Private Partnerships to Develop Hospitals, Government New Health Insurance Schemes and Growing Ageing Population
DUBLIN, Jan. 24, 2018 /PRNewswire/ --
The "South Africa Medical Device Market, Rules, and Regulations" report has been added to ResearchAndMarkets.com's offering.
South Africa medical device market is expected to grow at a CAGR of 8.97% 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 companies. 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 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.
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.
This report 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
Key Topics Covered:
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. 1
6.2 Increasing Healthcare Expenditure
7. Challenges
For more information about this report visit https://www.researchandmarkets.com/research/fhzdb4/south_africa?w=5
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