Medical Device Marketing Authorization (MDMA)

What is MDMA?

Medical Device Marketing Authorization (MDMA) is the official approval granted by Saudi FDA that allows companies to market and sell medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia. It ensures that your Medical Devices meet the necessary quality and safety standards before they are introduced to the market.

MDMA is a must-have for selling medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia.

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Process:

Step 1 - Document Review: We meticulously assess your documents for compliance.

Step 2 -Translation Assistance: We advise on necessary translations (English is preferred, Arabic only for specific cases).

Step 3 - Saudi FDA Submission: We handle the online application submission process.

Step 4 - Saudi FDA Communication: We represent you throughout the SFDA review process.

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‍Benefits of MDMA Approval:

Market Access: Sell your medical devices legally and safely in Saudi Arabia.

Credibility: Demonstrate product quality and regulatory compliance.

Growth Potential: Take advantage of a profitable and growing healthcare market.

‍

‍Why Choose Bio-Standards?

Expertise: We understand the Saudi FDA's requirements and bundling criteria for MDMA applications.

Full Support: We handle everything, from document review and translation to submission and communication with the Saudi FDA.

Compliance Guarantee: We ensure your documents meet all Saudi FDA regulations, saving you time and hassle.

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Timeline

- New MDMA application takes approximately 3 to 4 months starting from the date of submission of the application to the Saudi FDA. - Renewal/Update MDMA application takes approximately 6 to 8 weeks starting from the date of submission of the application to the Saudi FDA.

Validity

Renewal / Update

Renewal application can be initiated 3 months (90 days) prior to the expiry of the current MDMA license. New product is NOT allowed to be added
Update application (minor/major) can be initiated any time to notify SFDA of any changes in the existing documentation or to add models/products to the existing application.
What is MDMA?

Medical Device Marketing Authorization (MDMA) is the official approval granted by Saudi FDA that allows companies to market and sell medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia. It ensures that your Medical Devices meet the necessary quality and safety standards before they are introduced to the market.

MDMA is a must-have for selling medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia.

‍

Process:

Step 1 - Document Review: We meticulously assess your documents for compliance.

Step 2 -Translation Assistance: We advise on necessary translations (English is preferred, Arabic only for specific cases).

Step 3 - Saudi FDA Submission: We handle the online application submission process.

Step 4 - Saudi FDA Communication: We represent you throughout the SFDA review process.

‍

‍Benefits of MDMA Approval:

Market Access: Sell your medical devices legally and safely in Saudi Arabia.

Credibility: Demonstrate product quality and regulatory compliance.

Growth Potential: Take advantage of a profitable and growing healthcare market.

‍

‍Why Choose Bio-Standards?

Expertise: We understand the Saudi FDA's requirements and bundling criteria for MDMA applications.

Full Support: We handle everything, from document review and translation to submission and communication with the Saudi FDA.

Compliance Guarantee: We ensure your documents meet all Saudi FDA regulations, saving you time and hassle.

‍

‍

Timeline

- New MDMA application takes approximately 3 to 4 months starting from the date of submission of the application to the Saudi FDA. - Renewal/Update MDMA application takes approximately 6 to 8 weeks starting from the date of submission of the application to the Saudi FDA.

Validity

Renewal / Update

Renewal application can be initiated 3 months (90 days) prior to the expiry of the current MDMA license. New product is NOT allowed to be added
Update application (minor/major) can be initiated any time to notify SFDA of any changes in the existing documentation or to add models/products to the existing application.
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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