Authorized Representation (AR)

Why appoint Teriaqi as your Authorized Representation (AR)?

▪ Regulatory Compliance: ensuring that your products or medical devices comply with the SFDA’s regulations and
standards.
▪ Registration and Documentation: assisting you in the registration process of your medical devices with the SFDA and
maintain accurate records of all related documentation.
▪ Labeling and Packaging: ensuring that product labeling and packaging adhere to SFDA requirements, including language
and safety information.
▪ Communication with SFDA: As an Authorized Representative, We serve as the primary point of contact between the
foreign manufacturer and the SFDA, and handle all matters related to registration requirements, including document
review, ensuring compliance with regulations, addressing regulatory issues, and submitting documents to the Saudi Food
and Drug Authority (SFDA)
▪ Post-Market Surveillance: post-market surveillance and reporting adverse events or product recalls to the SFDA, if
applicable.
▪ Quality Assurance: involved in ensuring that products meet quality and safety standards and coordinating with the SFDA
for inspections and audits.

Manufacturers are presented with two distinct options when appointing an Authorized
Representative (AR)

1l Agreement between a single legal manufacturer and an authorized representative
2l Agreement between an organization representing multiple legal manufacturers within a single company and an
authorized representative

In cases where the legal manufacturer is situated outside the Kingdom of Saudi Arabia, the
agreement shall undergo authentication by the following parties:

1l Chamber of Commerce in foreign country.
2l The Ministry of Foreign Affairs in foreign country.
3l The Saudi embassy in the foreign country.
4l The Saudi Foreign Ministry.

On the other hand, if the legal manufacturer is based within the Kingdom of Saudi Arabia, the
agreement must undergo authentication by the following parties:

1l Chambers of Commerce and Industry.
2l The Embassy of the foreign party in the Kingdom.
3l The Saudi Foreign Ministry.