Saudi Arabia Medical Device Market Outlook 2018
Accounting for nearly 50% of the total Middle East market, the Saudi Arabian medical devices market is estimated around US$ 1.1 Billion in 2013 and is expected to surpass USD 1.6 Billion by 2018, by registering a growth of 9% CAGR. The medical device sector is being anticipated to represent a strong growth in the coming years owing to overall increase in the health care spending, growing penetration by the healthcare insurance, increase in the per capita income, and huge investment in both human resources and infrastructure. A lot of initiatives have been introduced on the health front, which formidably contribute towards a changing scenario in all the allied fields of healthcare. Much is being done in terms of development of the health care setup both in terms of new treatment centers being planned and improvement of existing facilities. Many new specialties and super specialties facilities are being planned and introduced, which indirectly lead to upsurge in the demand of medical devices, equipments and services.
Domestic production of medical devices is very limited and restricted to very few items, which has plagued the industry since long and has made the sector highly imports driven. Imports are estimated to account for more than 80% of the overall market value and will continue to dominate in future due to limited production and small base of domestic manufacturers. “Saudi Arabia Medical Device Market Outlook 2018” by KuicK Research gives comprehensive insight on following aspects related to medical device market in Saudi Arabia:
- Market Overview
- Market by Segment
- Emerging Market Trends
- Regulatory & Policy Framework
- Future Growth opportunities
- Competitive Landscape
2. SAUDI ARABIA MEDICAL DEVICE MARKET DYNAMICS
2.1 Factors Driving the Market
2.2 Challenges to be Resolved
2.3 Emerging Market Trends
3. SAUDI ARABIA MEDICAL DEVICE MARKET BY SEGMENT
3.1 Dental
3.2 Imaging Devices
3.3 Orthopaedics
3.4 Consumables
4. MEDICAL DEVICE TRADE IN SAUDI ARABIA
4.1 Exports
4.2 Imports
5. FUTURE GROWTH OPPORTUNITIES
5.1 Expansion of Local Medical Device Manufacturers
5.2 Imported Device to Dominate Market
5.3 Gateway to Middle East Medical Device Market
5.4 Medical Device Maintenance Services
6. MEDICAL DEVICE REGULATORY LANDSCAPE
6.1 Import License Requirements for Medical IVD Devices
6.2 Import License Requirements for Non-Medical IVD Devices
6.3 Storage, Handling & Transport of Medical Devices
6.4 Product Classification Requirements
7. COMPETITIVE LANDSCAPE
7.1 Saudi Pharmaceutical Industries & Medical Appliances Corporation (SPIMACO)
7.2 Alshifa Medical Syringes Manufacturing Co. Ltd
7.3 Jamjoom Hospital Supply (JHS)
7.4 Malesa MD&D
Figure 1-1: Medical Device Market Revenue (US$ Million), 2012 - 2018
Figure 1-2: Medical Device Market by Segment (%), 2012
Figure 3-1: Medical Device Market by Segment (%), 2013 & 2018
Figure 3-2: Dental Product Market (US$ million), 2012-2018
Figure 3-3: Dental Product Market by Segment (%), 2013 & 2018
Figure 3-4: Dental Chair & X-Ray Market (US$ million), 2012-2018
Figure 3-5: Dental Tools Market (US$ million), 2012-2018
Figure 3-6: Imaging Device Market (US$ million), 2012-2018
Figure 3-7: Imaging Device Market by Segment (%), 2013 & 2018
Figure 3-8: Electro Diagnostic Apparatus Market (US$ million), 2012-2018
Figure 3-9: X-Ray Machine Market (US$ million), 2012-2018
Figure 3-10: Orthopedics & Implantable Market (US$ million), 2012-2018
Figure 3-11: Medical Consumable Market (US$ million), 2012-2018
Figure 3-12: Medical Consumable Market by Segment (%), 2013 & 2018
Figure 3-13: Wound Care Market (US$ million), 2012-2018
Figure 3-14: Syringes & Needles Market (US$ million), 2012-2018
In Saudi Arabia, medical devices market is regulated by a governing agency called Saudi Food and Drug Authority (SFDA). SFDA was established in 2003 under the Council of Ministers resolution. The SFDA is an independent authority reporting to the Council of Ministers that aim to ensure the safety of food, safety, quality and effectiveness of drug, and the safety, quality, effectiveness and performance of medical devices according to their intended purpose. The other responsibilities of the SFDA are to regulate medical devices, in vitro-diagnostic devices, contact lenses and prescription eyeglasses.
In 2008, the SFDA has adopted an Interim Regulation for medical devices and this regulation will apply until the medical devices comprehensive law is approved. The reason behind the interim regulation is a safe delivery of medical devices to the consumers such as hospitals, day care centers OPD clinics, wholesale agents and others departments selling or dealing with supply of medical devices locally. This ensures a scrutinized procedure at the level of manufacturing, import, supply and sale hence this interim regulation is applicable to manufacturers, importers delivery and distributors.
The SFDA is working aggressively to improve Saudi Arabia’s medical device market. The SFDA has launched the Medical Devices National Registry (MDNR), Medical Device Establishment Licensing System (MDEL) and National Centre for Medical Devices Reporting (NCMDR). The main purpose of MDNR is to obtain profile/information of medical device company in the country and creating a database of all establishments, manufacturers, agents and suppliers. The profile consists of the following parameters:
- Name of a responsible person
- Manufacturer’s details
- Country of origin
- Identification code
- Pre-market approval, if any
- Post-marketing activities, if applicable
MDEL capture the information related to importation and distribution of medical devices in Saudi Arabia. The applicant has to register in MDNR and should be able to manage imported and distributed devices with respect to storage, transport, traceability and installation.
