Alqanoni

Law of Medical Devices and Supplies

Art. 2
Status unknownSaudi ArabiaRegulation

Issued by Ministry of Investment (misa.gov.sa)

The following activities shall be subject to the provisions of this Law: 1. Designing and manufacturing medical devices and supplies. 2. Importing, marketing, distributing, and storing medical devices and supplies. 3. Providing services to verify the conformity of medical devices and supplies with the technical regulations and the Quality Management System, and to verify quality assurance. 4. Verifying clinical studies. 5. Providing technical consultation services in the field of medical devices and supplies. 6. Providing inspection services of medical devices and supplies to ensure their conformity with the technical regulations and standards. 7. Providing maintenance services for medical devices and supplies. 8. Representing a manufacturer located outside the Kingdom.

The Arabic text is the legally binding version. The English translation is provided for guidance only.

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