medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or allevi­ation of disease,
• diag­nosis, monitoring, treatment, alleviation of or com­pensation for an injury e.g. disinfection substances , etc
• inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process e.g. prescription eye glasses , aids for disabled/handicapped people, etc
• supporting or sustaining life,
• con­trol of conception,
• disinfection of medical devices,
• providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

and which does not achieve its primary intended action in or on the human body by pharmaco­logical, immunological or metabolic means, but which may be assisted in its intended function by such means.

The following parties who operate their businesses in Saudi Arabia are invited to enroll.

• Manufacturers of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions .

• Exporters and importers of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions .

• Distributors/vendors of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions .  

Enrollment is online and only limited relevant information will be required. It consists of two main steps, namely;

• Step 1 : Account Creation
• Step 2 : Establishment Enrollment
• Section A : Establishment Information
• Section B : Authorized Person for the Establishment
• Section C : Medical Device Information
• Section D : Post-Market Requirements
• Section E : Application Declaration

1.  Documents require for Section A

• Business Registration Certificate.
• Chamber of Commerce Certificate.

2.  Documents require for Section B

• National Identity or Iqama.
• Official authorization letter from the Owner stamped from the company and approved from the Chamber of Commerce and Industry or legal authorization letter from the Court.

3.  Documents require for Section C

• Products Certificates such as "FDA, ISO, CE, ...etc".

4.  Documents require for Section D

• Quality System Certificate if available.

5   Documents require for Section E

• Declaration Form stamped and signed by the authorized person and approved from Chamber of Commerce & Industry.

You should received an activation code, probably it is in your (junk e-mail). You can get the activation code by clicking on “Resend Activation code” on the left side of the home page.