S.L. 458.59 · Medical Devices And In-Vitro Diagnostic (S.L. 458.59)
S.L. 458.59 Art. 7Issuing of approval.
(1) The issuing of any approval by the competent authority pursuant to these regulations shall be subject to:
(a) the submission by the applicant and the evaluation of documents, including due diligence documentation, and any other information as may be deemed necessary in order to ensure fulfilment of the authorisation requirements; and
(b) the attainment by the applicant of any authorisation, licence, permit, approval and clearance from the competent authority or any other entity as may be prescribed under these regulations or any other legislation that may be applicable from time to time:
Provided that the competent authority may, at its own discretion, request any additional information it deems necessary for the evaluation of the application.
(2) The withdrawal, revocation, cancellation or expiry of any authorisation issued pursuant to these regulations shall preclude the holder thereof from carrying out the relevant activity.