ترخيص تسويق الأجهزة الطبية (MDMA)

ترخيص تسويق الأجهزة الطبية (MDMA) في السعودية ومتطلبات SFDA

يُعد ترخيص تسويق الأجهزة الطبية (MDMA) موافقة تنظيمية صادرة من الهيئة العامة للغذاء والدواء السعودية (SFDA)، تُمكّن الشركات من تسويق وبيع الأجهزة الطبية والمخبرية (IVDs) داخل المملكة العربية السعودية. كما يدعم هذا الترخيص مواءمة الأجهزة الطبية مع متطلبات الجودة والسلامة قبل طرحها في السوق السعودي.

يُعد ترخيص MDMA متطلبًا أساسيًا لتسويق وبيع الأجهزة الطبية والمخبرية (IVDs) في المملكة العربية السعودية، ودعم دخول المنتجات إلى السوق السعودي وفق متطلبات SFDA.

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خطوات الحصول على ترخيص MDMA للأجهزة الطبية في السعودية

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الخطوة الأولى – مراجعة وثائق ترخيص MDMA

نقوم بمراجعة جميع المستندات بدقة للتأكد من توافقها مع متطلبات الهيئة العامة للغذاء والدواء السعودية.

الخطوة الثانية – دعم ترجمة وثائق ترخيص MDMA

نقدم الإرشاد حول الترجمة المطلوبة للمستندات (تُفضل اللغة الإنجليزية، بينما تُطلب اللغة العربية في حالات محددة فقط).

الخطوة الثالثة – تقديم طلب ترخيص MDMA لدى SFDA

ندعم عملية تقديم الطلب إلكترونيًا عبر أنظمة الهيئة العامة للغذاء والدواء السعودية (SFDA).

الخطوة الرابعة – متابعة طلب ترخيص MDMA مع SFDA

ندعم متابعة الطلب والتواصل مع الهيئة العامة للغذاء والدواء السعودية (SFDA) خلال فترة المراجعة.

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‍فوائد ترخيص MDMA لتسويق الأجهزة الطبية في السعودية

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• الوصول إلى السوق السعودي: دعم بيع وتسويق الأجهزة الطبية والمشخصات المخبرية (IVDs) داخل المملكة العربية السعودية وفق المتطلبات التنظيمية.

• تعزيز الموثوقية: مواءمة المنتج مع متطلبات الجودة والسلامة الخاصة بالهيئة العامة للغذاء والدواء السعودية (SFDA).

• فرص النمو: الاستفادة من نمو قطاع الرعاية الصحية وسوق الأجهزة الطبية في المملكة العربية السعودية.

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‍لماذا تختار Bio-Standards لخدمات ترخيص MDMA في السعودية؟

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•خبرة متخصصة: فهم عميق لمتطلبات الهيئة العامة للغذاء والدواء السعودية (SFDA) ومعايير تجميع المنتجات ضمن طلبات ترخيص MDMA.

• دعم متكامل: دعم العملية من مراجعة الوثائق والترجمة إلىتقديم طلب ترخيص MDMA والتواصل مع الهيئة.

• دعم الامتثال: مواءمة الوثائق مع متطلبات SFDA لتقليل التعقيدات ودعم مسار ترخيص أكثر وضوحًا وكفاءة.

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ابدأ إجراءات ترخيص MDMA في السعودية

تدعم Bio-Standards شركات الأجهزة الطبية والمصنعين الدوليين في الحصول على ترخيص MDMA لتسويق وبيع الأجهزة الطبية والمخبرية (IVDs) داخل المملكة العربية السعودية وفق متطلبات الهيئة العامة للغذاء والدواء السعودية (SFDA).

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الجدول الزمني

المدة الزمنية للحصول على ترخيص MDMA في السعودية

يستغرق طلب ترخيص حوالي 3 إلى 4 أشهر من تاريخ تقديم الطلب إلى الهيئة العامة للغذاء والدواء السعودية (SFDA).
وتستغرق طلبات تجديد أو تحديث ترخيص MDMA حوالي 6 إلى 8 أسابيع من تاريخ تقديم الطلب إلى الهيئة

الصلاحية

صلاحية ترخيص MDMA للأجهزة الطبية في السعودية

تبلغ مدة صلاحية شهادة MDMA ثلاث (3) سنوات للتسجيل والتي تتم عبر مسار تقييم الملف الفني (TFA).
بالنسبة للأجهزة الطبية متوسطة وعالية الخطورة، تصل صلاحية شهادة MDMA إلى حد أقصى ثلاث سنوات،مع مراعاة مدة صلاحية شهادات المطابقة الصادرة من الجهات الدولية المعترف بها إذاكانت أقل من ثلاث سنوات.
يتم احتساب صلاحية شهادة التجديد ابتداءً من تاريخ انتهاء الشهادة السابقة.

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تجديد وتحديث ترخيص MDMA للأجهزة الطبية في السعودية

يمكن بدء إجراءات تجديد ترخيص MDMA قبل 3 أشهر (90 يومًا) من تاريخ انتهاء الترخيص الحالي، ولا يُسمح بإضافة منتجات جديدة ضمن طلب التجديد.
يمكن تقديم طلبات تحديث ترخيص MDMA، سواء تعديل طفيف أو رئيسي، في أي وقت لإبلاغ الهيئة بأي تغييرات في الوثائق الحالية أو لإضافة نماذج منتجات إلى الطلب القائم.

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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