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Introduction
In accordance with the royal decree issued on 25/01/1428H (13 February 2007) which assigned the responsibility for regulating medical devices, in vitro diagnostic devices, prescription eye glasses, contact lenses and their solutions to the Saudi Food and Drug Authority (SFDA).
And the council of ministers decree No. 181 on 03/06/1428H ( 18 June 2007 ) which gives the SFDA full authority to issue guidance that include rules and procedures of registering medical devices establishments and their products.
In fulfillment of article three of the decree which appointed the SFDA to build
a database for all establishments working in the field of medical devices and their
products. The SFDA is pleased to launch the Medical Devices National Registry (MDNR)
to list all Medical Devices Establishments, manufacturers, agents and suppliers dealing with medical devices, in vitro diagnostics, prescription eye glasses, contact
lenses and their solutions and the products they deal with along with their country
of origin and any premarket approval they have from other international regulatory
authority.
What is a medical device?
'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:: MORE
Who Should Enroll?
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.
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Medical Devices National Registry (MDNR)
MDNR is an enrollment scheme for medical devices establishments, manufacturers, agents and suppliers in Saudi Arabia. It is a web-based enrollment system. All applications shall be made on-line. It consists of 2 parts. Part 1 is an account creation. Part 2 requests for information pertaining to medical devices establishments, manufacturers, agents and suppliers with respect to company profile, person responsible, medical devices particulars and pre and post-market details.
MDNR is not an approval system. Assignment of submission number and Registry number does not in any way constitute an admission or agreement by the SFDA to denote approval of an establishment and its products.
Purpose of MDNR
◊To obtain a profile of the Saudi Arabia medical devices industry.
◊To establish a database of all establishments, manufacturers, agents and suppliers working in the field of medical devices, in vitro diagnostics, prescription eye glasses, contact lenses and their solutions .
◊To measure the readiness of medical devices establishments in conforming to the regulatory requirements.
How To Enroll?
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 E:
Application Declaration.
All applications shall be made by using the MDNR online forms and must be accompanied
by relevant supporting documents as required.
Please note that the authenticity of any documents submitted may be verified with
the issuing authority or organization.
Security and Confidentiality of Data
◊All data submitted
online will be protected and encrypted via the MDNR security infrastructure.
All data provided will be used by SFDA.
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