ترخيص الإعلان للأجهزة والمستلزمات الطبية (MDAL)

نساعد مصنعي الأجهزة الطبية والمشخصات الطبية المخبرية (IVDs) في الحصول على موافقات MDAL للمواد الإعلانية والترويجية داخل المملكة العربية السعودية.

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مواءمة الحملات الترويجية للأجهزة الطبية مع متطلبات الهيئة العامة للغذاء والدواء السعودية (SFDA)

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تخضع أنشطة الدعاية والإعلان للأجهزة الطبية والمشخصات الطبية المخبرية (IVDs) في المملكة العربية السعودية لمتطلبات الهيئة العامة للغذاء والدواء السعودية (SFDA)،ويشمل ذلك التسويق الرقمي، حملات وسائل التواصل الاجتماعي، الفعاليات التعليمية،مواد التوعية بالمنتجات، والحملات الموجهة للممارسين الصحيين، حيث تتطلب هذه الأنشطة الحصول على موافقة مسبقة قبل النشر أو التوزيع.

تساعد Bio-Standards مصنعي الأجهزة الطبية والمشخصات المخبرية في الحصول على موافقات ترخيص الدعاية والإعلان للأجهزة الطبية (MDAL)،ومواءمة الأنشطة التسويقية والترويجية مع متطلبات SFDA ومعايير السوق السعودي.

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نطاق ترخيص الدعاية والإعلان للأجهزة الطبية (MDAL)

تنطبق متطلبات ترخيص MDAL على أنشطة الدعاية والإعلان للأجهزة الطبية داخل المملكة العربية السعودية، وتشم لما يلي:

الدعاية والإعلان للأجهزة والمستلزمات الطبية الموجهة للجمهور داخل المملكة العربية السعودية.
الحملات التوعوية أو الخيرية المتعلقة بالأجهزة والمستلزمات الطبية.
عرض الأجهزة الطبية في المعارض لأغراض العرض أو الترويج، حيث تخضع لمتطلبات وموافقات الهيئة العامة للغذاء والدواء السعودية (SFDA).
ورش العمل والعروض التقديمية التي تتضمن ادعاءات أو معلومات ترويجية متعلقة بالأجهزة الطبية، والتي يجب أن تمتثل للوائح الدعاية والإعلان المعتمدة من الهيئة.
الإعلان عن الأجهزة الطبية من خلال المؤثرين أو صانعي المحتوى عبر وسائل التواصل الاجتماعي، بما يتطلب الالتزام بالمتطلبات الترويجية المعتمدة من الهيئة.

ولا تنطبق متطلبات ترخيص MDAL على العينات المستوردة المخصصة للعرض فقط، حيث تخضع هذه العينات لمتطلبات استيراد منفصلة صادرة عن الهيئة العامة للغذاء والدواء السعودية (SFDA).

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كيف تساعد Bio-Standards في الحصول على موافقة MDAL؟

تقوم Bio-Standards في إدارة متطلبات موافقة MDAL للمواد الإعلانية والترويجية، بما يشمل:

مراجعة المواد الإعلانية للتأكد من توافقها مع متطلبات الهيئة.
مواءمة الادعاءات الترويجية مع وثائق MDMA المعتمدة.
دعم تقديم طلبات الموافقة الإعلانية.
المساعدة في الامتثال لحملات وسائل التواصل الاجتماعي وحملات المؤثرين.
دعم الموافقات الخاصة بالحملات التوعوية والتعليمية.
التنسيق المباشر مع الهيئة العامة للغذاء والدواء السعودية خلال عملية المراجعة.
تقديم الإرشادات المتعلقة بامتثال المحتوى باللغتين العربية والإنجليزية.

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لماذا تختار Bio-Standards لخدمات ترخيص MDAL؟

خبرة عميقة في أنظمة الهيئة العامة للغذاء والدواء السعودية الخاصة بالأجهزة الطبية.
فهم قوي لمتطلبات الامتثال الإعلاني في المملكة العربية السعودية.
خبرة مثبتة في دعم المصنعين الدوليين.
دعم متكامل بدءًا من موافقات MDMA وحتى الترويج التجاري للمنتجات.
تواصل أسرع وأكثر سلاسة مع الهيئة العامة للغذاء والدواء السعودية.

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روّج للأجهزة الطبية بثقة في المملكة العربية السعودية

يُعد الحصول على موافقة MDMA خطوة مهمة لدخول السوق، بينما تساعد موافقة MDAL على مواءمة الأنشطة التسويقية والترويجية للأجهزة الطبية مع متطلبات الهيئة العامة للغذاء والدواء السعودية (SFDA) داخل المملكة.

تواصل مع Bio-Standards لإدارة متطلبات موافقة MDAL للمواد الإعلانية والترويجية للأجهزة الطبية في السعودية.

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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

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

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

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

Xiaoyun Chen

Bgi Genomics Co., Ltd

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

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.

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

Mohammed Omer

Julwan For Trading ESt.

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

Borja Tórtola

Inbentus Medical Technology

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

Maher Bannourah

Koning International

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

Ali Ghaidan

RMDM

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

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

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

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

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

Huawei

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

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

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

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

Xiaoyun Chen

Bgi Genomics Co., Ltd

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

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.

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

Mohammed Omer

Julwan For Trading ESt.

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

Borja Tórtola

Inbentus Medical Technology

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

Maher Bannourah

Koning International

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

Ali Ghaidan

RMDM

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

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

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

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

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

Huawei

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

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

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

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

Xiaoyun Chen

Bgi Genomics Co., Ltd

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

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.

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

Mohammed Omer

Julwan For Trading ESt.

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

Borja Tórtola

Inbentus Medical Technology

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

Maher Bannourah

Koning International

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

Ali Ghaidan

RMDM

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

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

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

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

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

Huawei

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

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

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

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

Xiaoyun Chen

Bgi Genomics Co., Ltd

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

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.

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

Mohammed Omer

Julwan For Trading ESt.

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

Borja Tórtola

Inbentus Medical Technology

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

Maher Bannourah

Koning International

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

Ali Ghaidan

RMDM

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

Mohammad Alshammari

National Excellence for Business Solutions (NEXCO)

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

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