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Section 45

of Medical Device Act 2012

ActIn forceProvision 45 of 80

Section 45

(1)

An establishment may apply to the Authority for a permit to export a registered medical device in the prescribed form and accompanied by the prescribed fees.

(2)

The Authority may, after considering the application under subsection

(1)

, issue or refuse to issue a permit to export a registered medical device.

(3)

If the Authority decides to issue an export permit, it may impose such conditions as it thinks fit.

(4)

An establishment shall comply with the conditions imposed by the

Authority on the export permit.

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(5)

Any establishment who contravenes subsection (4) commits an offence and shall, on conviction, be liable to a fine not exceeding fifty thousand ringgit or to imprisonment for a term not exceeding six months or to both.