نظام إذن التسويق للأجهزة والمنتجات الطبية (MDMA)

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

يعد ترخيص تسويق الأجهزة الطبية (MDMA) أمرًا ضروريًا لبيع الأجهزة الطبية وأجهزة التشخيص المختبري (IVDs) في المملكة العربية السعودية. تساعدك شركة المقاييس الحيوية على التنقل في عملية التسجيل في الهيئة العامة للغذاء والدواء بسلاسة.

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لماذا تختار Bio-Standards؟

- الخبرة: نحن نفهم متطلبات الهيئة العامة للغذاء والدواء ومعايير التجميع لتطبيقات MDMA.

- الدعم الكامل: نحن نتعامل مع كل شيء، بدءًا من مراجعة المستندات وترجمتها وحتى تقديمها والتواصل مع الهيئة العامة للغذاء والدواء.

- ضمان الامتثال: نحن نضمن أن مستنداتك تتوافق مع جميع لوائح الهيئة العامة للغذاء والدواء، مما يوفر عليك الوقت والمتاعب.

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خدماتنا:

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

2- المساعدة في الترجمة: ننصح بالترجمات اللازمة (يفضل اللغة الإنجليزية، والعربية فقط لحالات محددة).

3- تقديم الطلب من الهيئة العامة للغذاء والدواء: نحن نتولى عملية تقديم الطلب عبر الإنترنت.

4- اتصالات الهيئة العامة للغذاء والدواء: نحن نمثلك خلال عملية مراجعة الهيئة العامة للغذاء والدواء.

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فوائد موافقة MDMA:

الوصول إلى الأسواق: قم ببيع أجهزتك الطبية بشكل قانوني وآمن في المملكة العربية السعودية.

المصداقية: إظهار جودة المنتج والامتثال التنظيمي.

إمكانات النمو: الاستفادة من سوق الرعاية الصحية المربح والمتنامي.

الجدول الزمني

- يستغرق طلب ترخيص تسويق الأجهزة الطبية الجديد حوالي 3 إلى 4 أشهر بدءاً من تاريخ تقديم الطلب إلى الهيئة العامة للغذاء والدواء.

- يستغرق تجديد/تحديث طلب ترخيص تسويق الأجهزة الطبية حوالي 6 إلى 8 أسابيع بدءاً من تاريخ تقديم الطلب إلى الهيئة.

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الصلاحية

- صلاحية ترخيص تسويق الأجهزة الطبية هي 3 سنوات للتسجيل المكتمل من خلال مسار تقييم الملف الفني (TFA).

- صلاحية ترخيص تسويق الأجهزة الطبية للأجهزة الطبية المتوسطة والعالية الخطورة تصل إلى 3 سنوات كحد أقصى، مع مراعاة صلاحية شهادات المطابقة الصادرة من الهيئات الدولية المعترف بها إذا كانت أقل من ثلاث سنوات.

- يتم احتساب صلاحية تجديد ترخيص تسويق الأجهزة الطبية من يوم انتهاء الترخيص القديم.

تجديد / تحديث نظام تصنيف المنتجات (PCS)

- يمكن بدء طلب التجديد قبل 3 أشهر (90 يومًا) من انتهاء ترخيص نظام إذن التسويق الحالي. لا يسمح بإضافة منتج جديد

- يمكن البدء في تحديث التطبيق (الفرعي / الرئيسي) في أي وقت لإبلاغ الهيئة العامة للغذاء والدواء بأي تغييرات في الوثائق الموجودة أو لإضافة نماذج/منتجات إلى التطبيق الحالي.

تواصل مع فريقنا
رسوم الهيئة العامة للغذاء والدواء
أساسيات طلب تصريح التسويق من الهيئة العامة للغذاء والدواء رسوم التقييم
جميع الفئة الأولى / A IVD العام (أخرى) / IVD المعفى (TGA) SAR 15,000
جميع الفئة الثانية / الفئة IIa / B الاختبار الذاتي IVD / IVD القابل للقائمة SAR 19,000
جميع الفئات IIb / الفئة III (CA,PAL) / C الملحق الثاني القائمة ب (IVD) SAR 21,000
جميع الفئات الأخرى من الفئة III / Class IV /AIMD / D الملحق الثاني القائمة أ (IVD) / IVD القابلة للتسجيل SAR 23,000
التحديث والتجديد (تعديلات طفيفة) SAR 1,100
تجديد (تحديث شهادة DE) SAR 1,500
التحديث والتجديد (التعديلات الرئيسية) SAR 5,000

"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

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

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

"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)

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

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

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

"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)

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

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

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

"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)

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

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

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

"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