Download MEDICAL DEVICES SECTOR

MEDICAL DEVICES SECTOR
Temporary Medical Devices Clearance Requirements
Developed Date
© Saudi Food and Drug Authority – Official Document
3 MAY 2010
Version 2.0
Temporary Medical Devices Clearance Requirements
Importers of Medical Devices are required to submit the following:
1.
Importers should:
A. register their establishments with the SFDA Medical Device National Registry MDNR.
B. list medical devices with the SFDA MDNR
(Chapter Four, Article Ten, Medical Device Interim Regulation)
2.
3.
4.
5.
Copy of SFDA Establishment License (MDEL)
Airway bill.
Copy of Commercial registration (CR).
Manufacturer’s original invoice stamped by the responsible party for commerce in the country
of origin that includes:
- Invoice Number.
- Manufacture Name.
- Shipment description (name of each item).
- Quantity of each item in shipment.
- Unit price of each item in shipment.
- Model / Part #.
6. Original Certificate of origin stamped by the responsible party for commerce in the country of
origin.
7. P.O Copy Distillation equipments used at health facility or medical Lab.
8. The importer must adhere to the manufacture transport and storage recommendation.
9. Ensure the labeling accompanies each medical device .
-labeling means written, printed or graphic matter :
a) Affixed to a medical device or any of its containers or wrappers.
b) Information accompanying a medical device related to identification, technical
description .
c) Information accompanying a medical device related to its used , but excluding shipping
document . (Chapter 1, Article 1,Medical Devices Interim Regulation)
10. Home used equipments or personal used medical devices must have instruction manual written
in Arabic language .
11. All medical devices must operates at 60 Hz (SASO 182 Standard Voltages And Frequency For
A.C Transmission And Distribution Systems )
© Saudi Food and Drug Authority – Official Document
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12. Medical devices clearance requirements:
10.1 the medical devices shall comply with the relevant regulatory requirements applicable in
one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA.
10.2 The following certificates will be required according to the medical device classifications
and the countries of approval:
USFDA:
 Classification of medical devices:
 Class I
 Class II
 Class III
 Certificates Required:
 510 K (for class I & II)
 PMA (for class III)
Note: certificate to foreign government is not accepted.
EU
 Classification of medical devices:
 Class I
 Class IIa
 Class IIb
 Class III
 Certificates Required:
 Class I without measuring function needs:
 Self declaration
 Class I measuring function and sterile products need:
 Certificate from Conformity Assessment Bodies (CABs)
 Class IIa, IIb &III need:
 Certificate from Conformity Assessment Bodies (CABs)
* CABs is a Conformity Assessment Bodies such as BSI and TUV.
For more information and details, please see below references:
 MMD 93/42/EEC - Medical Devices Directive.
 AIMDD 90/385/EEC- Active Implantable Medical Devices Directive .
IVDD 98/79/EC – (In-Vitro Diagnostic Device Directive) *
* need to be checked by IVD specialists
© Saudi Food and Drug Authority – Official Document
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TGA:
 Classification of medical devices:
 Class I
 Class Iia
 Class IIb
 Class III
 AIMD
 Certificates Required:
 For medical devices other than Class I medical devices that are supplied non-sterile
and/or do not have a measuring function:
 Certificate issued by a European Notified Body to an overseas manufacturer; or
 TGA Conformity Assessment Certificate issued by the TGA; or
 Certificate of conformity issued under the EC-MRA by a recognized European
Conformity Assessment Body to a European manufacturer
 For Active Implantable medical devices:
 Certificate issued by a European Notified Body to a overseas manufacturer; or
 TGA Conformity Assessment Certificate issued by the TGA
 For Invitro diagnostic devices:
 Certificate issued by a European Notified Body to an overseas manufacturer of
invitro diagnostic devices; or
 An International Standards Organization (ISO) 13485 certificate from a recognized
Notified Body.
Japan:
 Classification of medical devices:
 Class I
 Class II
 Class III
 Class IV
 Certificates Required:
 Self declaration (For Class I)
 Third party certification(For Class II)
 Governmental approval necessary (For Class III)
 Third party certification (For Class IV)
© Saudi Food and Drug Authority – Official Document
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