The driving factors behind the medical device industry are still evolving, as the Gulf Cooperation Council (GCC)’s healthcare expenditure is rising dramatically. To maintain this trajectory, The GCC has developed a portal called Taawon to facilitate the registration and approval of drugs and medical devices in GCC countries.

What is Taawon?

Taawon is a web-based portal that provides information and guidance to importers on the registration and approval process for drugs and medical devices in GCC countries; it also serves as a centralized platform for submitting and assessing applications and supporting documents to hasten the registration process.

Requirements in GCC Countries:

A set of guidelines and regulations for medical devices, called the Gulf Cooperation Council Technical Regulation (GCC-TR), was put in place by the GCC for the assessment, approval, and marketing of medical devices among its member countries. The GCC-TR strives to ensure the quality, safety, and efficacy of medical device regulations within the GCC region.

By submitting their applications and supporting documents to one central location through Taawon, importers can save time and resources; this is because this way, they can avoid navigating the various Regulatory requirements of each GCC country. This portal is anticipated to increase the efficiency and consistency of the GCC’s drug and medical device approval procedures.

It is important to understand that even though Taawon is predicted to make registration simpler for importers, they must still comply with the Regulatory standards of the specific GCC country where they intend to distribute their products. Taawon helps to speed up the procedure, but it does not replace local regulations.

What Information does Taawon Include?

• Regulatory Requirements: Information on the regulations and requirements for registering drugs and medical devices in the GCC countries, including the requirements of GCC-TR.
• Application Forms and Guidance: Access to the forms and guidance needed to complete the application process, including instructions on what information and documentation are required.
• Status Tracking: A feature that allows importers to track the status of their applications and view any requests for additional information, or clarification.
• Communication Tools: A platform for importers to communicate directly with the relevant Regulatory authorities, allowing them to ask questions and receive responses within a stipulated time period.

How to Create an Account in the Portal?

• Go to the Taawon procurement portal website and click on registration.
• Accept the user agreement.
• Fill in the information of the organization and the user.
• Once you have filled in the entire information, the account is created.

Benefits of Taawon:

• It is a centralized portal for accessing all guidelines and regulations.
• It provides a detailed understanding of document preparation.
• It makes way for easy tracking of the application.
• It enables communication with the Regulatory authorities.

Through the centralized Taawon platform, importers who desire to access the GCC markets can do so with ease. Since the GCC countries have a robust Regulatory system in place, obtaining approvals from them can occasionally be difficult and time-consuming since they follow a detailed process to maintain accurate documentation at all times. The importers can opt for an experienced Regulatory partner for appropriate Regulatory strategy and obtaining approvals.

To know more about Taawon, reach out to our Regulatory Experts today!