Medical Device - Unique Device Identification (UDI)

Unique Device Identification (UDI)

What is Unique Device Identification (UDI)?

UDI system aims to document unique devices codes for medical devices based on accredited international standards, with the purpose to allow all stakeholders to identify medical devices information through the unique device identification code that is registered on the system.

Manufacturers and their authorized representatives are directly responsible for submitting, maintaining, and modifying all data of unique device identification codes for their medical devices according to the SFDA guidance for UDI.

Benefits of Unique Device Identification (UDI)?

Standardized Identification: Ensures consistent device identification for streamlined processes.
Device Traceability: Enhances monitoring and control of devices throughout their lifecycle.
Fraud Prevention: Facilitates identification of counterfeit devices, bolstering patient safety.
Data Management: Supports effective management of recalls, corrective actions, and adverse events.
Lifecycle Efficiency: Establishes controls for efficient device management from inception to disposal.
Achieving Safety: Promotes device safety for improved healthcare outcomes

Saudi FDA may ask for further information, updates, or data verification at any time.

Timeline

Validity

Renewal / Update

A new listing is required if there is a change in the UDI code.
An update is required if there is a change in the data that does not require a new UDI code.

What is Unique Device Identification (UDI)?

UDI system aims to document unique devices codes for medical devices based on accredited international standards, with the purpose to allow all stakeholders to identify medical devices information through the unique device identification code that is registered on the system.

Manufacturers and their authorized representatives are directly responsible for submitting, maintaining, and modifying all data of unique device identification codes for their medical devices according to the SFDA guidance for UDI.

Benefits of Unique Device Identification (UDI)?

Standardized Identification: Ensures consistent device identification for streamlined processes.
Device Traceability: Enhances monitoring and control of devices throughout their lifecycle.
Fraud Prevention: Facilitates identification of counterfeit devices, bolstering patient safety.
Data Management: Supports effective management of recalls, corrective actions, and adverse events.
Lifecycle Efficiency: Establishes controls for efficient device management from inception to disposal.
Achieving Safety: Promotes device safety for improved healthcare outcomes

Saudi FDA may ask for further information, updates, or data verification at any time.

Timeline

Validity

Renewal / Update

A new listing is required if there is a change in the UDI code.
An update is required if there is a change in the data that does not require a new UDI code.

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"We've been with Bio-Standards for years, they're simply the best in the Saudi market. Professional, cooperative, and always meeting deadlines flawlessly. Their expertise with Saudi FDA requirements is unmatched. Highly recommended for medical device companies."

Sami N. Yousef, Managing Director

Centennial Medical Establishment

"We collaborated with Bio-Standards to secure our MDMA Class IIa (Class B) medical devices license. The team's excellent coordination made the process seamless and efficient. We obtained the license within 2 months and the AR license within a few weeks. Looking forward to future collaborations with the Bio-Standards team!"

Perminder Rupra, CEO

Elipse Health Limited (United Kingdom)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

"Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents or content needed for successful registration of our products on the Saudi market. Much appreciated."

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

Amrit Gill

Allengers

"It's truly a big surprise for us! We really appreciate the effort you all made for this tight project. Thank you very much!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"We really appreciate all the efforts Bio-Standards has made in assisting Mindray with regulatory affairs in Saudi Arabia. So far, the services provided by Bio-Standards for Mindray have been really nice and professional."

Tracey Hao

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

"We are eager to continue our collaboration with your company. The work you did last year was outstanding, and we are grateful for it!"

Yan

PMLS Upstream Marketing Department of Mindray

"We've been with Bio-Standards for years, they're simply the best in the Saudi market. Professional, cooperative, and always meeting deadlines flawlessly. Their expertise with Saudi FDA requirements is unmatched. Highly recommended for medical device companies."

Sami N. Yousef, Managing Director

Centennial Medical Establishment

"We collaborated with Bio-Standards to secure our MDMA Class IIa (Class B) medical devices license. The team's excellent coordination made the process seamless and efficient. We obtained the license within 2 months and the AR license within a few weeks. Looking forward to future collaborations with the Bio-Standards team!"

Perminder Rupra, CEO

Elipse Health Limited (United Kingdom)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

"Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents or content needed for successful registration of our products on the Saudi market. Much appreciated."

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

Amrit Gill

Allengers

"It's truly a big surprise for us! We really appreciate the effort you all made for this tight project. Thank you very much!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"We really appreciate all the efforts Bio-Standards has made in assisting Mindray with regulatory affairs in Saudi Arabia. So far, the services provided by Bio-Standards for Mindray have been really nice and professional."

Tracey Hao

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

"We are eager to continue our collaboration with your company. The work you did last year was outstanding, and we are grateful for it!"

Yan

PMLS Upstream Marketing Department of Mindray

"We've been with Bio-Standards for years, they're simply the best in the Saudi market. Professional, cooperative, and always meeting deadlines flawlessly. Their expertise with Saudi FDA requirements is unmatched. Highly recommended for medical device companies."

Sami N. Yousef, Managing Director

Centennial Medical Establishment

"We collaborated with Bio-Standards to secure our MDMA Class IIa (Class B) medical devices license. The team's excellent coordination made the process seamless and efficient. We obtained the license within 2 months and the AR license within a few weeks. Looking forward to future collaborations with the Bio-Standards team!"

Perminder Rupra, CEO

Elipse Health Limited (United Kingdom)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

"Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents or content needed for successful registration of our products on the Saudi market. Much appreciated."

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

Amrit Gill

Allengers

"It's truly a big surprise for us! We really appreciate the effort you all made for this tight project. Thank you very much!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"We really appreciate all the efforts Bio-Standards has made in assisting Mindray with regulatory affairs in Saudi Arabia. So far, the services provided by Bio-Standards for Mindray have been really nice and professional."

Tracey Hao

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

"We are eager to continue our collaboration with your company. The work you did last year was outstanding, and we are grateful for it!"

Yan

PMLS Upstream Marketing Department of Mindray

"We've been with Bio-Standards for years, they're simply the best in the Saudi market. Professional, cooperative, and always meeting deadlines flawlessly. Their expertise with Saudi FDA requirements is unmatched. Highly recommended for medical device companies."

Sami N. Yousef, Managing Director

Centennial Medical Establishment

"We collaborated with Bio-Standards to secure our MDMA Class IIa (Class B) medical devices license. The team's excellent coordination made the process seamless and efficient. We obtained the license within 2 months and the AR license within a few weeks. Looking forward to future collaborations with the Bio-Standards team!"

Perminder Rupra, CEO

Elipse Health Limited (United Kingdom)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

"Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents or content needed for successful registration of our products on the Saudi market. Much appreciated."

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

Amrit Gill

Allengers

"It's truly a big surprise for us! We really appreciate the effort you all made for this tight project. Thank you very much!"

Jelly , Regulatory Affairs

NingboSoundway Medical Appliances Co , Ltd

"We really appreciate all the efforts Bio-Standards has made in assisting Mindray with regulatory affairs in Saudi Arabia. So far, the services provided by Bio-Standards for Mindray have been really nice and professional."

Tracey Hao

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

"We are eager to continue our collaboration with your company. The work you did last year was outstanding, and we are grateful for it!"

Yan

PMLS Upstream Marketing Department of Mindray