Attestation accompanying Application for Marketing Authorization

[To be printed on Manufacturer Letterhead]

Name and Address of Manufacturer:

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I hereby declare that medical device(s ) and accessory(ies) in this application (No. _ _ _ _ _) complies with:

1. The provisions of the medical device regulations that apply within the GHTF Founding Member
jurisdiction that has been selected as the basis of the application.
2. The specific KSA national provisions within the MEDICAL DEVICES INTERIM REGULATION.

GHTF Founding Member jurisdiction that has been selected as the basis of the application, selected from:
AUSTRALIA / CANADA / EU / JAPAN / USA.
[Please delete if not applicable]

Authorised Signatory:

Name:..........................................

Job Title:.....................................

Signature:....................................

Date:...........................................