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Medical device registration

العربية تحت رعاية صاحب المعالي وزير الصحة المهندس خالد بن عبد العزيز

Medical device registration

It is a harmonized medical device registration system in Gulf Health Council between all GCC countries. In our registrations system, no medical device is being registered until safety, performance and quality standards have been met. Description and information related to the device are registered and company manufacturing process is being checked and approved.

The main purposes of the registration system are:

- Register medical devices centrally among GCC countries.

- Harmonizing classification rules for medical devices between GCC countries.

- Establish a new harmonized electronic system that will enhance the registration process by making it more efficient and effective.

- Harmonizing regulations and procedures of medical device registration.

- Enhancing the cooperation between GCC countries in medical device field.

- Following the international standards in site inspection.

Medical device bylaws:

Medical device registration bylaws is a document that represents the framework of the registration process and the guidelines and procedures conducted within the medical device department.

Medical device registration committee:

Competent members of the committee make assessment for medical devices in an unbiased – internationally - harmonized manner. They register medical devices based on their safety, quality and performance. As well as that, continuously update medical device bylaws as per any international change or modifications.

Objectives of the committee:

- Study company dossier and register medical devices accordingly.

- Study companies' requests for making scientific modifications on their medical products.

- Continuously develop medical devices bylaws by adapting to the global changes and new technology innovations.

- Post market vigilance on the marketed registered items to assure safety and quality control.