ترخيص الممثل المعتمد للأجهزة الطبية

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هل تحتاج إلى تسجيل جهازك الطبي في المملكة العربية السعودية؟

بصفتك شركة مصنعة للأجهزة الطبية خارج المملكة، فإن الخطوة الحاسمة الأولى هي تعيين ممثل معتمد محلي (AR) يحمل ترخيص ممثل معتمد. وهذا يضمن الامتثال للوائح إدارة الغذاء والدواء السعودية.

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‍‍نحن نبسط اختيار ممثل معتمد محلي:

يمكن أن تكون Bio-Standards ممثلك المعتمد الذي يستحق ثقتك. نحن نتعامل مع كلا النوعين من تفويضات الممثل المعتمد:

- اتفاقية ممثل معتمد في موقع واحد: اتفاقية ممثل معتمد بين الشركة المصنعة وBio-Standards، ويتم استخدام هذه الاتفاقية إذا تم تصنيع المنتجات التي سيتم تسجيلها في موقع واحد.

- اتفاقية ممثل معتمد في مواقع متعددة: اتفاقية ممثل معتمد بين الشركة المصنعة وBio-Standards، ويتم استخدام هذه الاتفاقية إذا تم تصنيع المنتجات التي سيتم تسجيلها في أكثر من موقع، ويجب إدراج جميع المواقع في اتفاقية الممثل المعتمد.
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‍الحصول على موافقة هيئة الغذاء والدواء السعودية أصبحت سهلة
  1. إذا كان المصنع القانوني يقع خارج المملكة العربية السعودية، فيجب التصديق على الاتفاقية على النحو التالي:

البلد العضو في (اتفاقية لاهاي):

"التصديق" الذي تم إصداره من قبل هيئة معتمدة في البلد الأجنبي.

البلد غير العضو في (اتفاقية لاهاي):

أ) غرفة التجارة في البلد الأجنبي.

ب) وزارة الخارجية في البلد الأجنبي.
ج) السفارة السعودية في البلد الأجنبي.
د) وزارة الخارجية السعودية.

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  1. إذا كان المصنع القانوني يقع داخل المملكة العربية السعودية، فيجب التصديق على الاتفاقية من قبل جميع الأطراف التالية:

أ) غرفة التجارة والصناعة.
ب) سفارة الطرف الأجنبي في المملكة.
ج) وزارة الخارجية السعودية.

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‍ركز على عملك، ونحن نتولى المهمة

دع شركة Bio-Standards تتولى التعقيدات المتعلقة بتسجيل اعتماد هيئة الغذاء والدواء السعودية. سنكون خيارك الأمثل في إنجاز المستندات المطلوبة والمصادقة عليها وضمان عملية تسجيل سلسة ومتوافقة مع المتطلبات.

الامتثال المضمون لمتطلبات هيئة الغذاء والدواء السعودية

معرفتنا العميقة في تفويض المستندات المطلوبة تلبي جميع متطلبات هيئة الغذاء والدواء السعودية. كما نتولى عملية المصادقة والترخيص، مما يوفر عليك الوقت والمتاعب.

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الفترة الزمنية

AR license can be attained within 1-2 weeks from the date of submission.

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الصلاحية

No Validity

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التجديد / التحديث

يمكن تقديم طلب تجديد رخصة القيادة قبل شهرين من تاريخ انتهاء صلاحيتها. لا يمكن التقدم بطلب تجديد رخصة القيادة إلا باستخدام تفويض قيادة موثق صالح لعدد سنوات التجديد المطلوبة.

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تواصل مع فريقنا
Saudi FDA Fees

رسوم ترخيص AR: 2600 ريال سعودي سنويًا

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احصل على استشارة مجانية بخصوص:

ترخيص الممثل المعتمد للأجهزة الطبية

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"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