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Medical Devices Registration Requirements

General Requirements:

1.    Submit Valid Copy of Local Agent / Distributor License.

2.    Submit License (A) Medical Device.

3.    Registration the manufacturer And Agent / Distributor at the national medicine & Poison board records according to the medicines & Poison law 2009.

4.    Fill the Application Form for Medical Devices Registration.

5.    Prepare Medical Devices registration Dossier and must contain all require documents and information complete and correct (The Documents must be in Arabic/ English).

6.    Pay the required fees.

Specific Requirements:

1.    Cover Letter for application request.

2.     Application Form for medical device registration.

3.    Submit international Quality Certificate (FDA, CE… etc.).

4.    Fill Declaration of conformity Form for the product (in NMPB website).

5.    Submit Product description, specification and intend use of medical devices.

6.    Copy of Medical Devices Label (Colored & Clear).

7.    Catalogue.

Notes:

-       In Medical Furniture insure the design safety, international sizes, and materials used in design, paint type, easy to clean and the edges are not convex.

-       Medical Devices accessories subject to import requirements & Guidelines only.