Medical Device Importation & Distribution License

Medical Device Establishment License (MDEL), Medical Device Importation License (MDIL)

What is the Medical Device Establishment License (MDEL)?

Medical Device Establishment License (MDEL) authorizes a company to establish facilities for the local manufacturers,  storage, and importer & distribution of medical devices. Any entity operating a medical device establishment in Saudi Arabia must obtain an MDEL from the Saudi FDA.


What is the Medical Device Importation License (MDIL)?

Medical Device Importation License (MDIL) is a Licensing system for the establishments involved in the importation of medical devices to KSA. The Importation License shall be obtained before the shipment and it needs to be applied through the importer/distributor account. MDIL is required for IVDs, Non-Medical IVDs, Chemicals, Distillation, Gases, Demos, Research and Educational use products.
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Bio-Standards aids in securing MDEL and MDIL licenses by:

  • Offering regulatory guidance specific to MDEL and MDIL requirements.
  • Assisting with documentation preparation tailored to MDEL and MDIL applications.
  • Ensuring timely and accurate submission of MDEL and MDIL license applications.
  • Handling communications with authorities regarding MDEL and MDIL inquiries.
  • Guaranteeing adherence to MDEL and MDIL regulations for successful licensing.

Timeline

The service timeline varies depending on the type of medical device and imported medical products.

Validity

No Validity

Renewal / Update

医疗器械进口至沙特阿拉伯

Unique Device Identification (UDI)

Saudi FDA Fees

No applicable fees for obtaining MDIL.

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Related Services

Unique Device Identification (UDI)

Unique Device Identification (UDI)

医疗器械进口至沙特阿拉伯

Medical Device Establishment License (MDEL), Medical Device Importation License (MDIL)

医疗器械进口至沙特阿拉伯
Unique Device Identification (UDI)

We sincerely thank Bio Standards for outstanding registration support, expert solutions, smooth cooperation, and dedication throughout.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Thank you for your effort and professionalism. We truly appreciate your accuracy, dedication, and the excellent support throughout our collaboration.

Ayman Salama

Semac for medical services

For the past three years, we entrusted all regulatory business to Bio-Standards due to their strong reputation, quality service, caring team, and vast

Eng. Saad Al Gharman

ALMADAR MEDICAL Co.

We have worked with Bio Standards for years and value their professional, experienced, supportive, and punctual team with strong SFDA expertise.

Sami N. Yousef

CenteMed Medical Establishment

Bio-Standards is a highly efficient and professional team. This has been a smooth, successful, and valuable cooperation.

Xiaoyun Chen

Bgi Genomics Co., Ltd

Working with Bio-Standards has been a pleasure. They provided timely guidance on regulations, kept us updated, and ensured smooth market entry into Sa

Pablo Sanchez

Lexington Medical, Inc.

Outstanding experience with Bio-Standards. Strong regulatory expertise, efficient execution, clear communication, and reliable support throughout.

Borja Tórtola

Inbentus Medical Technology

Pleasure working with your team—professional, responsive, and detail-oriented. Smooth, efficient process with strong commitment to quality.

Ali Ghaidan

RMDM

Extremely satisfied with Bio-Standards. Expert, responsive support ensured smooth submissions and helped secure multiple Saudi licenses.

Nicole

Maxigen Biotech Inc.

Professional, reliable support for Saudi market access. Strong expertise, responsiveness, and commitment helped grow our business.

Hiroaki Hashimoto

EIZO Corporation

We are very willing to continue cooperating with your company. Your excellent work, dedicated support, and professionalism last year were appreciated.

Yan (D)

Mindray

We truly appreciate all your efforts and sincerely thank your team for the continuous support and cooperation throughout the process.

Max Zheng

Acon Biotech (Hangzhou) Co.,Ltd.

Wonderful news! Thank you very much for your excellent support, professional assistance, and help with renewing this application successfully.

Charlotte TESTA

Integra LifeSciences Services

Special thanks to Bio Standards for excellent registration support, practical solutions, professional guidance, and efficient problem-solving.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Bio Standards provided responsive, detail-oriented regulatory support that ensured smooth documentation handling and successful Saudi market entry.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

The Bio Standards team handled our MDMA registration exceptionally well with expert guidance, responsive support, and smooth process completion.

Nooraldin Abo Kamal

Meditek Trading Est

We certify that BIO-STANDARDS LLC provided satisfactory SFDA product registration services with swift efforts and professional support in Saudi Arabia

Amrit Gill

Allengers

To BIO-STANDARDS LLC, in appreciation of outstanding regulatory consultation services delivered with professionalism, excellence, and timely support.

Dr. Talal AlGhamdi (D)

Medical ActTect

We thank Bio Standards for their excellent support, professional team, outstanding service, and reliable regulatory and registration expertise.

Dr. Mohammed Shaheen (D)

Keydent est

Having registered products in 40+ countries, we consider Bio Standards among the best consultancies for efficient SFDA registration and Saudi market a

Safwan Abdallah (D)

MicroSafe

Bio-Standards shows strong professionalism, reliability, and excellence. Proactive, communicative, and delivers high-quality results that exceed expec

Maher Bannourah

Koning International

Professional team with strong technical expertise, reliable support, consistent quality service, and trusted long-term cooperation.

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

Huawei values Bio-Standards’ professionalism and efficiency. With strong support, we met Saudi-FDA requirements and achieved our goals.

Huawei

Huawei

Great experience with your team. Professional, timely, and dedicated, with strong understanding of needs and effective solutions.

Mohammed Omer

Julwan For Trading ESt.

Very positive experience with your team. Professional, responsive, and reliable with smooth communication. We value this partnership.

Joanna Lin

Medprin Biotech GmbH

Great experience with Bio Standards for SFDA registration. Strong support, excellent service, and Dana Saad’s responsiveness made it smooth.

Perminder Rupra

Elipse Health Limited

We sincerely thank Bio Standards for outstanding registration support, expert solutions, smooth cooperation, and dedication throughout.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Thank you for your effort and professionalism. We truly appreciate your accuracy, dedication, and the excellent support throughout our collaboration.

Ayman Salama

Semac for medical services

For the past three years, we entrusted all regulatory business to Bio-Standards due to their strong reputation, quality service, caring team, and vast

Eng. Saad Al Gharman

ALMADAR MEDICAL Co.

We have worked with Bio Standards for years and value their professional, experienced, supportive, and punctual team with strong SFDA expertise.

Sami N. Yousef

CenteMed Medical Establishment

Bio-Standards is a highly efficient and professional team. This has been a smooth, successful, and valuable cooperation.

Xiaoyun Chen

Bgi Genomics Co., Ltd

Working with Bio-Standards has been a pleasure. They provided timely guidance on regulations, kept us updated, and ensured smooth market entry into Sa

Pablo Sanchez

Lexington Medical, Inc.

Outstanding experience with Bio-Standards. Strong regulatory expertise, efficient execution, clear communication, and reliable support throughout.

Borja Tórtola

Inbentus Medical Technology

Pleasure working with your team—professional, responsive, and detail-oriented. Smooth, efficient process with strong commitment to quality.

Ali Ghaidan

RMDM

Extremely satisfied with Bio-Standards. Expert, responsive support ensured smooth submissions and helped secure multiple Saudi licenses.

Nicole

Maxigen Biotech Inc.

Professional, reliable support for Saudi market access. Strong expertise, responsiveness, and commitment helped grow our business.

Hiroaki Hashimoto

EIZO Corporation

We are very willing to continue cooperating with your company. Your excellent work, dedicated support, and professionalism last year were appreciated.

Yan (D)

Mindray

We truly appreciate all your efforts and sincerely thank your team for the continuous support and cooperation throughout the process.

Max Zheng

Acon Biotech (Hangzhou) Co.,Ltd.

Wonderful news! Thank you very much for your excellent support, professional assistance, and help with renewing this application successfully.

Charlotte TESTA

Integra LifeSciences Services

Special thanks to Bio Standards for excellent registration support, practical solutions, professional guidance, and efficient problem-solving.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Bio Standards provided responsive, detail-oriented regulatory support that ensured smooth documentation handling and successful Saudi market entry.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

The Bio Standards team handled our MDMA registration exceptionally well with expert guidance, responsive support, and smooth process completion.

Nooraldin Abo Kamal

Meditek Trading Est

We certify that BIO-STANDARDS LLC provided satisfactory SFDA product registration services with swift efforts and professional support in Saudi Arabia

Amrit Gill

Allengers

To BIO-STANDARDS LLC, in appreciation of outstanding regulatory consultation services delivered with professionalism, excellence, and timely support.

Dr. Talal AlGhamdi (D)

Medical ActTect

We thank Bio Standards for their excellent support, professional team, outstanding service, and reliable regulatory and registration expertise.

Dr. Mohammed Shaheen (D)

Keydent est

Having registered products in 40+ countries, we consider Bio Standards among the best consultancies for efficient SFDA registration and Saudi market a

Safwan Abdallah (D)

MicroSafe

Bio-Standards shows strong professionalism, reliability, and excellence. Proactive, communicative, and delivers high-quality results that exceed expec

Maher Bannourah

Koning International

Professional team with strong technical expertise, reliable support, consistent quality service, and trusted long-term cooperation.

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

Huawei values Bio-Standards’ professionalism and efficiency. With strong support, we met Saudi-FDA requirements and achieved our goals.

Huawei

Huawei

Great experience with your team. Professional, timely, and dedicated, with strong understanding of needs and effective solutions.

Mohammed Omer

Julwan For Trading ESt.

Very positive experience with your team. Professional, responsive, and reliable with smooth communication. We value this partnership.

Joanna Lin

Medprin Biotech GmbH

Great experience with Bio Standards for SFDA registration. Strong support, excellent service, and Dana Saad’s responsiveness made it smooth.

Perminder Rupra

Elipse Health Limited

We sincerely thank Bio Standards for outstanding registration support, expert solutions, smooth cooperation, and dedication throughout.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Thank you for your effort and professionalism. We truly appreciate your accuracy, dedication, and the excellent support throughout our collaboration.

Ayman Salama

Semac for medical services

For the past three years, we entrusted all regulatory business to Bio-Standards due to their strong reputation, quality service, caring team, and vast

Eng. Saad Al Gharman

ALMADAR MEDICAL Co.

We have worked with Bio Standards for years and value their professional, experienced, supportive, and punctual team with strong SFDA expertise.

Sami N. Yousef

CenteMed Medical Establishment

Bio-Standards is a highly efficient and professional team. This has been a smooth, successful, and valuable cooperation.

Xiaoyun Chen

Bgi Genomics Co., Ltd

Working with Bio-Standards has been a pleasure. They provided timely guidance on regulations, kept us updated, and ensured smooth market entry into Sa

Pablo Sanchez

Lexington Medical, Inc.

Outstanding experience with Bio-Standards. Strong regulatory expertise, efficient execution, clear communication, and reliable support throughout.

Borja Tórtola

Inbentus Medical Technology

Pleasure working with your team—professional, responsive, and detail-oriented. Smooth, efficient process with strong commitment to quality.

Ali Ghaidan

RMDM

Extremely satisfied with Bio-Standards. Expert, responsive support ensured smooth submissions and helped secure multiple Saudi licenses.

Nicole

Maxigen Biotech Inc.

Professional, reliable support for Saudi market access. Strong expertise, responsiveness, and commitment helped grow our business.

Hiroaki Hashimoto

EIZO Corporation

We are very willing to continue cooperating with your company. Your excellent work, dedicated support, and professionalism last year were appreciated.

Yan (D)

Mindray

We truly appreciate all your efforts and sincerely thank your team for the continuous support and cooperation throughout the process.

Max Zheng

Acon Biotech (Hangzhou) Co.,Ltd.

Wonderful news! Thank you very much for your excellent support, professional assistance, and help with renewing this application successfully.

Charlotte TESTA

Integra LifeSciences Services

Special thanks to Bio Standards for excellent registration support, practical solutions, professional guidance, and efficient problem-solving.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Bio Standards provided responsive, detail-oriented regulatory support that ensured smooth documentation handling and successful Saudi market entry.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

The Bio Standards team handled our MDMA registration exceptionally well with expert guidance, responsive support, and smooth process completion.

Nooraldin Abo Kamal

Meditek Trading Est

We certify that BIO-STANDARDS LLC provided satisfactory SFDA product registration services with swift efforts and professional support in Saudi Arabia

Amrit Gill

Allengers

To BIO-STANDARDS LLC, in appreciation of outstanding regulatory consultation services delivered with professionalism, excellence, and timely support.

Dr. Talal AlGhamdi (D)

Medical ActTect

We thank Bio Standards for their excellent support, professional team, outstanding service, and reliable regulatory and registration expertise.

Dr. Mohammed Shaheen (D)

Keydent est

Having registered products in 40+ countries, we consider Bio Standards among the best consultancies for efficient SFDA registration and Saudi market a

Safwan Abdallah (D)

MicroSafe

Bio-Standards shows strong professionalism, reliability, and excellence. Proactive, communicative, and delivers high-quality results that exceed expec

Maher Bannourah

Koning International

Professional team with strong technical expertise, reliable support, consistent quality service, and trusted long-term cooperation.

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

Huawei values Bio-Standards’ professionalism and efficiency. With strong support, we met Saudi-FDA requirements and achieved our goals.

Huawei

Huawei

Great experience with your team. Professional, timely, and dedicated, with strong understanding of needs and effective solutions.

Mohammed Omer

Julwan For Trading ESt.

Very positive experience with your team. Professional, responsive, and reliable with smooth communication. We value this partnership.

Joanna Lin

Medprin Biotech GmbH

Great experience with Bio Standards for SFDA registration. Strong support, excellent service, and Dana Saad’s responsiveness made it smooth.

Perminder Rupra

Elipse Health Limited

We sincerely thank Bio Standards for outstanding registration support, expert solutions, smooth cooperation, and dedication throughout.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Thank you for your effort and professionalism. We truly appreciate your accuracy, dedication, and the excellent support throughout our collaboration.

Ayman Salama

Semac for medical services

For the past three years, we entrusted all regulatory business to Bio-Standards due to their strong reputation, quality service, caring team, and vast

Eng. Saad Al Gharman

ALMADAR MEDICAL Co.

We have worked with Bio Standards for years and value their professional, experienced, supportive, and punctual team with strong SFDA expertise.

Sami N. Yousef

CenteMed Medical Establishment

Bio-Standards is a highly efficient and professional team. This has been a smooth, successful, and valuable cooperation.

Xiaoyun Chen

Bgi Genomics Co., Ltd

Working with Bio-Standards has been a pleasure. They provided timely guidance on regulations, kept us updated, and ensured smooth market entry into Sa

Pablo Sanchez

Lexington Medical, Inc.

Outstanding experience with Bio-Standards. Strong regulatory expertise, efficient execution, clear communication, and reliable support throughout.

Borja Tórtola

Inbentus Medical Technology

Pleasure working with your team—professional, responsive, and detail-oriented. Smooth, efficient process with strong commitment to quality.

Ali Ghaidan

RMDM

Extremely satisfied with Bio-Standards. Expert, responsive support ensured smooth submissions and helped secure multiple Saudi licenses.

Nicole

Maxigen Biotech Inc.

Professional, reliable support for Saudi market access. Strong expertise, responsiveness, and commitment helped grow our business.

Hiroaki Hashimoto

EIZO Corporation

We are very willing to continue cooperating with your company. Your excellent work, dedicated support, and professionalism last year were appreciated.

Yan (D)

Mindray

We truly appreciate all your efforts and sincerely thank your team for the continuous support and cooperation throughout the process.

Max Zheng

Acon Biotech (Hangzhou) Co.,Ltd.

Wonderful news! Thank you very much for your excellent support, professional assistance, and help with renewing this application successfully.

Charlotte TESTA

Integra LifeSciences Services

Special thanks to Bio Standards for excellent registration support, practical solutions, professional guidance, and efficient problem-solving.

Eng. Yasser Salah

Al-Kawader Scientific Company for Trading & Medical Supplies

Bio Standards provided responsive, detail-oriented regulatory support that ensured smooth documentation handling and successful Saudi market entry.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

The Bio Standards team handled our MDMA registration exceptionally well with expert guidance, responsive support, and smooth process completion.

Nooraldin Abo Kamal

Meditek Trading Est

We certify that BIO-STANDARDS LLC provided satisfactory SFDA product registration services with swift efforts and professional support in Saudi Arabia

Amrit Gill

Allengers

To BIO-STANDARDS LLC, in appreciation of outstanding regulatory consultation services delivered with professionalism, excellence, and timely support.

Dr. Talal AlGhamdi (D)

Medical ActTect

We thank Bio Standards for their excellent support, professional team, outstanding service, and reliable regulatory and registration expertise.

Dr. Mohammed Shaheen (D)

Keydent est

Having registered products in 40+ countries, we consider Bio Standards among the best consultancies for efficient SFDA registration and Saudi market a

Safwan Abdallah (D)

MicroSafe

Bio-Standards shows strong professionalism, reliability, and excellence. Proactive, communicative, and delivers high-quality results that exceed expec

Maher Bannourah

Koning International

Professional team with strong technical expertise, reliable support, consistent quality service, and trusted long-term cooperation.

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

Huawei values Bio-Standards’ professionalism and efficiency. With strong support, we met Saudi-FDA requirements and achieved our goals.

Huawei

Huawei

Great experience with your team. Professional, timely, and dedicated, with strong understanding of needs and effective solutions.

Mohammed Omer

Julwan For Trading ESt.

Very positive experience with your team. Professional, responsive, and reliable with smooth communication. We value this partnership.

Joanna Lin

Medprin Biotech GmbH

Great experience with Bio Standards for SFDA registration. Strong support, excellent service, and Dana Saad’s responsiveness made it smooth.

Perminder Rupra

Elipse Health Limited