National Center for Medical Devices Reporting (NCMDR)

What is NCMDR?

The Saudi FDA's NCMDR gathers and assesses data on medical device safety and performance, allowing stakeholders to report incidents for improved safety and compliance in Saudi Arabia by contacting the Authorized Representative (AR) on behalf of the manufacturer.

This data-driven system enhances safety standards, identifies issues, and facilitates necessary regulatory actions.

                                       

Benefits of Saudi FDA NCMDR

  • Enhanced Patient Safety: By collecting and analyzing reports of Failure Safety Notice (FSN), adverse events,  and malfunctions, the NCMDR helps identify risks associated with medical devices.
  • Improved Device Quality: The feedback from the NCMDR allows manufacturers to identify and resolve issues with their devices.
  • Regulatory Actions: The Saudi FDA uses data from the NCMDR to take timely and appropriate regulatory actions, such as issuing recalls, safety alerts, or additional testing which can be only performed by the manufacturers.
  • Continuous Improvement: The NCMDR facilitates continuous monitoring and improvement of medical devices throughout their lifecycle as long as they have access to the Saudi market.

Timeline

Response to the NCMDR is as follows:

  • Very High Risk: 2 working days
  • High Risk: 5 working days
  • Moderate Risk: 10 working days

Manufacturer Reporting Requirements

  • Serious public health threat: Within 2 days of awareness
  • Unanticipated death or serious injury: Within 10 days of awareness
  • Adverse events not associated with high risks: Within 30 days of awareness
  • SFDA-Initiated Reports Responses: within 5 days after initiation
*This consolidated guideline emphasizes the importance of reporting and responding promptly to adverse events, ensuring effective monitoring and mitigation of risks to public health and safety

Validity

No Validity

Renewal / Update

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Saudi FDA Fees

No applicable fees for NCMDR.

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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