ترخيص الممثل المعتمد للهيئة العامة للغذاء والدواء

هل تحتاج إلى تسجيل جهازك الطبي في المملكة العربية السعودية؟

باعتبارك شركة مصنعة خارج المملكة، فإن الخطوة الحاسمة الأولى هي تعيين ممثل معتمد محلي مرخص (AR). وهذا يضمن الامتثال للوائح الهيئة العامة للغذاء والدواء.

نحن نبسط اختيارك للممثل المعتمد في المملكة:

باعتبارنا خبراء في فهم لوائح الهيئة العامة للغذاء والدواء السعودية، فإن المقاييس الحيوية يمكنها أن تكون ممثل معتمد موثوق به. نحن نتعامل مع كلا النوعين من تفويضات الممثل المعتمد:

- مُصنع واحد: اتفاقية بين شركتك وفريق الخبراء لدينا.

- شركات مصنعة متعددة: اتفاقية تمثل علامات تجارية متعددة داخل شركتك.

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الامتثال المضمون لمتطلبات الهيئة العامة للغذاء والدواء

تضمن معرفتنا المتعمقة أن ترخيص ممثل معتمد خاص بشركتك في السعودية يلبي جميع متطلبات الهيئة العامة للغذاء والدواء. نحن نتعامل أيضًا مع عملية المصادقة على أجهزتك الطبية، مما يوفر لك الوقت والمتاعب.

وفقًا لتعليمات الهيئة العامة للغذاء والدواء، يتطلب تفويض الممثل المعتمد الخاص بك المصادقة عن طريق:

- الغرفة التجارية في بلدك.

- وزارة الخارجية في بلدك.

- السفارة السعودية في بلدك.

- وزارة الخارجية السعودية.

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ركز على عملك، واترك لنا عملية تسجيل منتجك في السعودية

فريق Bio-Standards جاهزون لحل تعقيدات التسجيل في الهيئة العامة للغذاء والدواء. سنكون مرجعك الشامل في ترخيص أجهزتك والمصادقة وضمان عملية تسجيل سلسة ومتوافقة مع شروط الجهات المعنية

الجدول الزمني

يمكن الحصول على ترخيص ممثل محلي معتمد خلال أسبوع إلى أسبوعين من تاريخ التقديم.

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الصلاحية

تجديد / تحديث نظام تصنيف المنتجات (PCS)

يمكن تقديم طلب تجديد ترخيص ممثل معتمد قبل شهرين من تاريخ انتهاء الصلاحية. لا يمكن تطبيق ترخيص ممثل معتمد إلا باستخدام تفويض مصادق عليه وصالح للعدد المطلوب من سنوات التجديد.

تواصل مع فريقنا

"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