نظام إذن التسويق للأجهزة والمنتجات الطبية (MDMA)

ما هو نظام إذن التسويق للأجهزة والمنتجات الطبية (MDMA)؟

نظام إذن التسويق للأجهزة والمنتجات الطبية (MDMA) هو الموافقة الرسمية الممنوحة من قبل هيئة الغذاء والدواء السعودية والتي تسمح للشركات بتسويق وبيع الأجهزة الطبية وأجهزة التشخيص المختبري (IVDs) في المملكة العربية السعودية. ويضمن أن الأجهزة الطبية الخاصة بك تلبي معايير الجودة والسلامة اللازمة قبل طرحها في السوق.

يعد نظام MDMA ضروريًا لبيع الأجهزة الطبية وأجهزة التشخيص المختبري (IVDs) في المملكة العربية السعودية.

‍

خطوات الحصول على تسجيل MDMA:

الخطوة 1 - مراجعة المستندات: نقوم بتقييم مستنداتك بدقة للتأكد من الامتثال.

الخطوة 2 - مساعدة الترجمة: نقدم المشورة بشأن الترجمات اللازمة (يفضل اللغة الإنجليزية، والعربية فقط لحالات محددة).

الخطوة 3 - تقديم الطلب إلى هيئة الغذاء والدواء السعودية: نتولى عملية تقديم الطلب عبر الإنترنت.

الخطوة 4 - التواصل مع هيئة الغذاء والدواء السعودية: نمثلك طوال عملية مراجعة هيئة الغذاء والدواء السعودية.

‍

‍فوائد الحصول على موافقة MDMA:

الوصول إلى السوق: بيع أجهزتك الطبية بشكل قانوني وآمن في المملكة العربية السعودية.

المصداقية: إثبات جودة المنتج والامتثال التنظيمي.

زيادة فرص النمو: الاستفادة من الدخول لسوق الرعاية الصحية المربح والمتنامي في المملكة.

‍

‍لماذا تختار Bio-Standards؟

الخبرة: نحن نفهم متطلبات هيئة الغذاء والدواء السعودية ومعايير التجميع لتطبيقات MDMA.

الدعم الكامل: نتولى كل شيء، من مراجعة المستندات وترجمتها إلى التقديم والتواصل مع هيئة الغذاء والدواء السعودية.

ضمان الامتثال: نضمن أن مستنداتك تلبي جميع شروط هيئة الغذاء والدواء السعودية، مما يوفر عليك الوقت والمتاعب.

‍

‍

الفترة الزمنية

الصلاحية

التجديد / التحديث

يمكن تقديم طلب التجديد قبل 3 أشهر (90 يومًا) من انتهاء صلاحية ترخيص MDMA الحالي. لا يُسمح بإضافة منتج جديد
يمكن البدء في تحديث التطبيق (الصغرى/الرئيسية) في أي وقت لإخطار الهيئة العامة للغذاء والدواء بأي تغييرات في الوثائق الموجودة أو لإضافة نماذج/منتجات إلى التطبيق الموجود.

‍

تواصل مع فريقنا
Saudi FDA Fees
تبلغ مدة صلاحية شهادة MDMA ثلاث سنوات للتسجيل الذي تم من خلال طريق تقييم الملف الفني (TFA).
تصل مدة صلاحية شهادة MDMA للأجهزة الطبية متوسطة وعالية الخطورة إلى حد أقصى 3 سنوات، مع الأخذ بعين الاعتبار مدة صلاحية شهادات المطابقة الصادرة عن الهيئات الدولية المعترف بها إذا كانت أقل من 3 سنوات.
يتم احتساب صلاحية شهادة MDMA المتجددة من يوم انتهاء صلاحية الشهادة القديمة.

احصل على استشارة مجانية بخصوص:

نظام إذن التسويق للأجهزة والمنتجات الطبية (MDMA)

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

خدماتنا

No items found.
No items found.

"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)

It has been three years since we decided to hand over all the regulatory busines to Bio-Standards. I believe this was the right decision due to the good reputation of Bio-Standards Company, good performance, a caring team, and wide experience in this field.

CEO

ALMADAR MEDICAL

This is to certify that the services provided by BIO-STANDARDS LLC, AL RIYADH, Kingdom of Saudi Arabia, towards SFDA registration of our products are good and satisfactory. We appreciate their efforts for registering our products in the quickest possible time.

Amrit Gill

Allengers

Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents and/or content needed for successful registration of our products on the Saudi market. Much appreciated.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"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 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.

"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'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)

It has been three years since we decided to hand over all the regulatory busines to Bio-Standards. I believe this was the right decision due to the good reputation of Bio-Standards Company, good performance, a caring team, and wide experience in this field.

CEO

ALMADAR MEDICAL

This is to certify that the services provided by BIO-STANDARDS LLC, AL RIYADH, Kingdom of Saudi Arabia, towards SFDA registration of our products are good and satisfactory. We appreciate their efforts for registering our products in the quickest possible time.

Amrit Gill

Allengers

Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents and/or content needed for successful registration of our products on the Saudi market. Much appreciated.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"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 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.

"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'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)

It has been three years since we decided to hand over all the regulatory busines to Bio-Standards. I believe this was the right decision due to the good reputation of Bio-Standards Company, good performance, a caring team, and wide experience in this field.

CEO

ALMADAR MEDICAL

This is to certify that the services provided by BIO-STANDARDS LLC, AL RIYADH, Kingdom of Saudi Arabia, towards SFDA registration of our products are good and satisfactory. We appreciate their efforts for registering our products in the quickest possible time.

Amrit Gill

Allengers

Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents and/or content needed for successful registration of our products on the Saudi market. Much appreciated.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"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 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.

"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'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)

It has been three years since we decided to hand over all the regulatory busines to Bio-Standards. I believe this was the right decision due to the good reputation of Bio-Standards Company, good performance, a caring team, and wide experience in this field.

CEO

ALMADAR MEDICAL

This is to certify that the services provided by BIO-STANDARDS LLC, AL RIYADH, Kingdom of Saudi Arabia, towards SFDA registration of our products are good and satisfactory. We appreciate their efforts for registering our products in the quickest possible time.

Amrit Gill

Allengers

Bio-Standards has been very responsive and extremely attentive to detail when it comes to the documents and/or content needed for successful registration of our products on the Saudi market. Much appreciated.

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"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 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.

"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