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South Africa Medical Device Market, Rules, and Regulations

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    Report

  • 92 Pages
  • January 2018
  • Region: South Africa
  • Renub Research
  • ID: 4450676

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 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.

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

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.

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

Table of Contents


1. Executive Summary2. South Africa Medical Device Market3. 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
7.1 Point No. 1
7.2 Point No. 2
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
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

Methodology

In this report, for analyzing the future trends for the studied market during the forecast period, the publisher has incorporated rigorous statistical and econometric methods, further scrutinized by secondary, primary sources and by in-house experts, supported through their extensive data intelligence repository. The market is studied holistically from both demand and supply-side perspectives. This is carried out to analyze both end-user and producer behavior patterns, in the review period, which affects price, demand and consumption trends. As the study demands to analyze the long-term nature of the market, the identification of factors influencing the market is based on the fundamentality of the study market.

Through secondary and primary researches, which largely include interviews with industry participants, reliable statistics, and regional intelligence, are identified and are transformed to quantitative data through data extraction, and further applied for inferential purposes. The publisher's in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models sanitize the data & statistics and enhance the accuracy of their recommendations and advice.

Primary Research

The primary purpose of this phase is to extract qualitative information regarding the market from the key industry leaders. The primary research efforts include reaching out to participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions. The publisher also established professional corporate relations with various companies that allow us greater flexibility for reaching out to industry participants and commentators for interviews and discussions, fulfilling the following functions:

  • Validates and improves the data quality and strengthens research proceeds
  • Further develop the analyst team’s market understanding and expertise
  • Supplies authentic information about market size, share, growth, and forecast

The researcher's primary research interview and discussion panels are typically composed of the most experienced industry members. These participants include, however, are not limited to:

  • Chief executives and VPs of leading corporations specific to the industry
  • Product and sales managers or country heads; channel partners and top level distributors; banking, investment, and valuation experts
  • Key opinion leaders (KOLs)

Secondary Research

The publisher refers to a broad array of industry sources for their secondary research, which typically includes, however, is not limited to:

  • Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
  • Patent and regulatory databases for understanding of technical & legal developments
  • Scientific and technical writings for product information and related preemptions
  • Regional government and statistical databases for macro analysis
  • Authentic new articles, webcasts, and other related releases for market evaluation
  • Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecasts
 

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