Medical Device AR Licensing

.

Need to Register your Medical Device in Saudi Arabia?

‍As an overseas manufacturer, the first crucial step is appointing a local Authorized Representative (AR) with an AR license. This ensures compliance with Saudi FDA regulations.

‍
‍We Simplify Your AR Selection:

‍Bio-Standards, your Saudi FDA regulations experts, can be your trusted AR. We handle both types of AR mandates:

- Single-Site AR agreement: AR Agreement between the manufacturer and Bio-Standards, this agreement to be used if the products that will be registered are manufactured in one site.

- Multiple-Site AR agreement: AR Agreement between the manufacturer and Bio-Standards, this agreement to be used if the products that will be registered are manufactured in more than one site, all the sites should be listed in the AR agreement.
‍

‍Saudi FDA Authentication Made Easy
  1. If the legal manufacturer is located outside the Kingdom of Saudi Arabia, the agreement shall be authenticated as the following:

The country member of (Hague Convention):

“Apostille” that been issued by an accredited body in the foreign country.

The country not member of (Hague Convention):

A) Chamber of Commerce in foreign country.
B) The Ministry of Foreign Affairs in foreign country.
C) The Saudi embassy in the foreign country.
D) The Saudi Foreign Ministry.

‍

  1. If the legal manufacturer is located within the Kingdom of Saudi Arabia, the agreement shall be authenticated by all of the following parties:

A) Chambers of Commerce and Industry.
B) The Embassy of the foreign party in the Kingdom.
C) The Saudi Foreign Ministry.

‍
‍Focus on Your Business, We Handle the Rest

‍Let Bio-Standards navigate the complexities of Saudi FDA registration. We'll be your one-stop place for AR selection, authentication, and ensuring a smooth, compliant registration process.

Guaranteed Compliance with Saudi FDA Requirements

Our in-depth knowledge ensures your AR mandate fulfills all Saudi FDA requirements. We also handle the authentication process, saving you time and hassle.

‍

Timeline

Validity

Renewal / Update

Need to Register your Medical Device in Saudi Arabia?

‍As an overseas manufacturer, the first crucial step is appointing a local Authorized Representative (AR) with an AR license. This ensures compliance with Saudi FDA regulations.

‍
‍We Simplify Your AR Selection:

‍Bio-Standards, your Saudi FDA regulations experts, can be your trusted AR. We handle both types of AR mandates:

- Single-Site AR agreement: AR Agreement between the manufacturer and Bio-Standards, this agreement to be used if the products that will be registered are manufactured in one site.

- Multiple-Site AR agreement: AR Agreement between the manufacturer and Bio-Standards, this agreement to be used if the products that will be registered are manufactured in more than one site, all the sites should be listed in the AR agreement.
‍

‍Saudi FDA Authentication Made Easy
  1. If the legal manufacturer is located outside the Kingdom of Saudi Arabia, the agreement shall be authenticated as the following:

The country member of (Hague Convention):

“Apostille” that been issued by an accredited body in the foreign country.

The country not member of (Hague Convention):

A) Chamber of Commerce in foreign country.
B) The Ministry of Foreign Affairs in foreign country.
C) The Saudi embassy in the foreign country.
D) The Saudi Foreign Ministry.

‍

  1. If the legal manufacturer is located within the Kingdom of Saudi Arabia, the agreement shall be authenticated by all of the following parties:

A) Chambers of Commerce and Industry.
B) The Embassy of the foreign party in the Kingdom.
C) The Saudi Foreign Ministry.

‍
‍Focus on Your Business, We Handle the Rest

‍Let Bio-Standards navigate the complexities of Saudi FDA registration. We'll be your one-stop place for AR selection, authentication, and ensuring a smooth, compliant registration process.

Guaranteed Compliance with Saudi FDA Requirements

Our in-depth knowledge ensures your AR mandate fulfills all Saudi FDA requirements. We also handle the authentication process, saving you time and hassle.

‍

Timeline

Validity

Renewal / Update

Get a proposal

Related Services

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)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

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

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

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)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

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

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

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)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

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

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

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)

"In the past three years, we have entrusted all the Regulatory business to Bio-Standards. I believe this was the right decision due to Bio-Standards' good reputation, Quality of Performance, Caring team, and Vast experience."

CEO

ALMADAR MEDICAL

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

Frank Rooijakkers

KANEKA PHARMA EUROPE NV

"We certify that the services provided by BIO-STANDARDS LLC in Al Riyadh, Kingdom of Saudi Arabia, for SFDA product registration are good & satisfactory. We appreciate their swift efforts in registering our products."

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