Extends Deadlines for Saudi Arabia SFDA Guidance on UDI

Saudi Arabia SFDA Guidance on UDI

A wide range of medical devices are available in the market. The rising concerns related to medical devices like patients’ safety and supply chain management has forced the introduction of a single, unique, globally harmonized identification system for every device.

UNIQUE IDENTIFICATION IDENTIFIER

The US FDA has established the unique identification system to every medical device, with a purpose to identify the device sold in the US market. The label of the medical device would include Unique Device Identifier (UDI) with numeric or alphanumeric code. The UDI system is adopted in various countries like China, Australia, Europe, Brazil, Japan, Saudi Arabia etc. Saudi Arabia SFDA guidance on UDI has captured attention these days due its new updates on extent ending deadlines for compliance.

GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUIDD)

The Global Unique Device Identification Database (GUDID) is a database by FDA that serves as a reference catalogue for the medical devices with unique device identifier. GUDID contains only the Device Identifier (DI) portion of the device and not the product Identifiers (PI).

PURPOSE OF UDI

• The UDI system provides single, unique and globally accepted device identification which makes it easy to trace the device through distribution and use.
• It helps in easy identification of devices in adverse events and taking corrective actions towards it.
• The system facilitates steps towards patients’ safety.
• It helps in reduction in medical errors by simplifying and integrating the information of the device.

Read More -  Saudi Arabia SFDA Guidance on UDI

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Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

Product Development Medical Devices

Product Development  Medical Devices

The medical device sector has a remarkable impact on the healthcare industry and is expanding its role in the global economy. It is significantly evolving over the span of years.  Advancement in scientific knowledge and engineering technology has accelerated the innovation in medical devices. Medical device technology is interdisciplinary and individuals need its assistance in day-to-day life for example contact lenses, thermometer, glasses etc.  Increase in the number of medical facilities has boosted the demand for the medical devices.

The latest technology medical devices include 

• Smart inhalers for Asthma
• Wireless brain sensors to measure the temperature and pressure 
• Artificial organs like blood vessels 

The global market for medical devices is expected to reach new heights in forthcoming years.  The medical device market size has increased its potential and shifted its power from pharmaceutical to device making. The huge gap between supply and demand has advanced the production lines for the Indian companies. India ranks 20th in the manufacturing of medical devices. 

Design and Development of a Medical Device 

Unlike every product, the development of medical devices has defined stages of the lifecycle to ensure the hallmarks which include quality, consistency and patients’ safety. An effective medical device is one which complies with the regulatory requirements, and delivers the functionalities to the end user. The key elements to be considered during the development of medical devices include the safety and efficacy of the product.

Read More - Product Development  Medical Devices

Visit Us - Medical device consulting

Read More Article - 

1.Orthopedic Implants Manufacturing

2.Dental Implants Manufacturing

3.Blood Collection Tubes Manufacturing

4. How to start the Manufacturing of Disposable Syringes?

5. disposable syringe manufacturers

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

 

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device